Chef d’équipe principal des données (Senior Data Team Lead)

IQVIA; Victoria; On-site; CAD 80,000 - 100,000; Full time

Job summary

Un fournisseur mondial de services de recherche clinique basé à Victoria recrute un chef de projet de gestion des données pour gérer l'exécution de projets complexes. Le candidat idéal aura une expérience avérée en gestion de données cliniques, des compétences en négociation, et saura travailler au sein d'une équipe dynamique pour garantir la qualité des livrables. Ce poste offre l'opportunité de travailler sur des études à échelle mondiale tout en respectant les exigences réglementaires.

Benefits

Conditions de travail flexibles

Opportunités de développement professionnel

Qualifications

• 7 ans d'expérience directe en gestion de données, dont 5 ans comme chef de projet.
• Compétences avérées en gestion des données et en mise en œuvre d'essais cliniques.
• Capacité à établir des relations de travail efficaces avec les clients et collègues.

Responsibilities

• Gérer de manière autonome l'exécution des projets de gestion des données.
• Assurer la communication avec le client et gérer les obligations contractuelles.
• Former et encadrer le personnel junior en gestion des données.

Skills

Compétences en gestion de projet

Capacité de négociation

Connaissance des bonnes pratiques cliniques

Education

Baccalauréat en sciences de la santé, sciences cliniques, biologiques ou mathématiques

Tools

Logiciels de gestion de données

Job description

French Version

Aperçu du poste

• Gérer de manière autonome la réalisation de bout en bout des services de gestion des données pour des projets à service unique ou multiple, en veillant à ce que les produits livrés soient de qualité, dans le respect des délais et du budget, et à la satisfaction du client. Fournir une expertise complète en matière de gestion des données à l’équipe de gestion des données cliniques (GDC) afin de fournir des produits de gestion des données de haute qualité qui répondent aux besoins des clients. Assurer la direction de l’équipe et la guider dans les domaines de la planification, de l’exécution et de la clôture du projet, de la gestion financière, de la communication et des résultats intermédiaires. Le candidat peut assumer le rôle de chef d’équipe de données (Data Team Lead, DTL), de chef de programme, de responsable de centre client et / ou un rôle de leadership dans une tâche spécifique relative à la GDC (par exemple, expert en la matière [EM]). Se conformer aux bonnes pratiques cliniques (BPC), aux lignes directrices réglementaires applicables, aux modes opératoires normalisés (MON), aux politiques et, le cas échéant, aux documents d’orientation de la GDC.

La gestion de la clientèle

• Faire office de point de contact principal pour le client en ce qui concerne les produits de gestion des données.
• Gérer plusieurs études ou programmes d’études de grande envergure (éventuellement à l’échelle mondiale). Fournir un encadrement et un soutien de haut niveau aux DTL sur plusieurs études / programmes d’études de grande envergure à l’échelle mondiale.
• Apporter une compétence en matière de gestion de projet en travaillant avec les gestionnaires de données des clients, les décideurs clés et les membres de l’équipe interne afin de gérer les améliorations continues des processus, la remontée des problèmes, les projections de la charge de travail et de fournir une expertise technique.
• Mener des négociations directes avec le client, par exemple en ce qui concerne les délais, les aspects financiers, les processus et les ressources.
• Entretenir de solides relations avec les clients.
• Assurer une communication transparente avec le client et la direction d’IQVIA afin de gérer et de respecter les obligations contractuelles de manière indépendante.

La gestion des services

• Organiser régulièrement des réunions avec le coordinateur des opérations de données (Data Operations Coordinator, DOC) et / ou les membres de l’équipe des opérations de données afin de s’assurer que les étapes sont respectées et que les résultats sont de qualité.
• Fournir une formation et un développement sur l’expertise en gestion de données aux membres juniors de l’équipe.
• Mettre en place une communication forte avec l’équipe des opérations de données, les responsables fonctionnels, les chefs de projet et toutes les autres personnes concernées.
• Gérer de manière autonome la prestation de services de gestion des données en s’appuyant sur des processus de gestion des données complets et sur une expertise technique dans l’exécution des projets.
• Servir de point de référence pour les problèmes de données non résolus.
• Collaborer de manière indépendante avec les gestionnaires de données des clients, les fournisseurs et les membres de l’équipe interne pour résoudre les problèmes.
• Veiller à ce que les ressources appropriées soient désignées pour atteindre les objectifs fixés pour le projet.
• Créer et / ou réviser et approuver tous les documents du plan de gestion des données (PGD).
• Veiller à ce que le service et la qualité répondent aux spécifications convenues selon le PGD et le contrat / l’énoncé des travaux.
• Mettre en œuvre des plans proactifs de gestion de la qualité dans le cadre de plusieurs projets / programmes / comptes clients. Gérer les performances des services et faire preuve de leadership pour identifier les causes profondes des problèmes et mettre en œuvre des mesures correctives.
• Rechercher continuellement des opportunités pour améliorer le service.
• Élaborer et collaborer avec l’équipe pour mettre en œuvre un plan de réorganisation et de changement (éventuellement sur l’ensemble d’un compte client)
• Assurer le suivi et la résolution en temps opportun des problèmes de conformité.
• Servir d’expert en la matière (EM)
• Fournir un encadrement et une expertise dans une tâche ou une technologie de la GDC spécifique.
• Servir de responsable de centre client pour un ou plusieurs clients.
• Former et encadrer le personnel junior du DTL en matière d’expertise en gestion des données.
• Le candidat peut coordonner le travail des employés moins expérimentés du DTL.
• Maintenir de manière indépendante des bases de données et des systèmes de suivi internes.

Soutien à la gestion financière et au développement des affaires

• Gérer de manière indépendante l’énoncé des travaux / le budget.
• Passer en revue les rapports financiers mensuels et participer à l’examen des projets, le cas échéant.
• Identifier les tâches qui sont hors de portée et suivre les ordres de modification jusqu’à leur achèvement.
• Participer aux négociations sur les prix pour l’ensemble des comptes clients.
• Agir en tant que chef de projet pour des projets de gestion de données à service unique, y compris le suivi financier, la comptabilisation des produits et la facturation.
• Soutenir de manière indépendante le processus d’appel d’offres (examiner les documents d’appel d’offres, les prix, assister à la défense de l’offre).

Autres

• Apporter de manière indépendante des améliorations de processus et des solutions à l’équipe GDC / au département GDC.
• Diriger une équipe spécialisée ou une équipe mondiale ou locale responsable des meilleures pratiques.
• Transmettre les enseignements tirés de l’expérience et / ou les présenter dans le cadre d’un ou plusieurs ateliers sur la GDC.
• Gérer le développement et la mise en œuvre d’une nouvelle technologie ou d’un nouvel outil.
• Présenter lors de conférences professionnelles et / ou publier des articles dans des revues professionnelles.
• Apporter un examen et un avis d’expert dans le cadre de l’élaboration, de la révision et de la mise à jour des procédures opérationnelles de base et des instructions de travail.
• Effectuer d’autres tâches selon les directives du gestionnaire fonctionnel.

Formation

• Baccalauréat en sciences de la santé, sciences cliniques, biologiques ou mathématiques, ou dans un domaine connexe requis.
• 7ans d’expérience directe en gestion de données, dont 5ans ou plus en tant que chef de projet GDC. Une combinaison adéquate d’éducation, de formation et d’expérience.
• Expérience préalable et compétence avérée dans la gestion de la mise en œuvre de multiples essais mondiaux tout au long du cycle de vie relatif à la gestion des données (c’est-à-dire des essais de grande envergure portant sur au moins 1000patients).
• Aptitudes avérées en matière de gestion des données et connaissance approfondie du processus de gestion des données (par exemple, domaine thérapeutique, connaissance approfondie des processus de gestion des données, rapprochement des EIG, rapprochement des fournisseurs de données externes, gestion des données des laboratoires locaux et / ou nouvelles technologies).
• Expérience préalable et compétence avérée dans la gestion autonome de négociations complexes avec les clients et de réunions de défense des offres.
• Connaissance des procédures opérationnelles et des instructions de travail et capacité de les appliquer dans la pratique.
• Connaissance des bonnes pratiques cliniques et des directives réglementaires pertinentes.
• Compréhension approfondie du processus de développement clinique de médicaments.
• Capacité à établir et à entretenir des relations de travail efficaces avec les collègues, les gestionnaires et les clients.
• Connaissance de la terminologie médicale, de la pharmacologie, de l’anatomie et / ou de la physiologie.

English Version

• Job Overview
• Independently manage end-to-end delivery of data management services for single / multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, Customer Site Manager, and / or a leadership role in a specific CDM task (e.g., Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

Essential Functions

Client Management :

• Serve as primary point of contact for customer on data management deliverables.
• Manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global studies / programs of global studies Provide leadership and senior support to DTLs on multiple large global studies / programs of global studies.
• Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.
• Lead direct negotiations with customer, e.g., timelines, financial, process, resources.
• Maintain strong customer relationships.
• Ensure open communications with customer and IQVIA management to independently manage and meet contractual obligations.

Service Management :

• Meet with Data Operations Coordinator (DOC) and / or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables.
• Provide training and development on data management expertise to junior team members.
• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders.
• Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
• Serve as the escalation point for unresolved data issues.
• Independently work with client data managers, vendors, internal team members for resolution
• Ensure appropriate resources are assigned to meet project deliverables.
• Create and / or review and sign-off on all data management plan (DMP) documents.
• Ensure service and quality meet agreed upon specifications per the DMP and contract / SOW.
• Implement proactive quality management plans across multiple projects / programs / customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions.
• Continuously look for opportunities to improve service.
• Develop and work with team to implement plan to re-organize and drive change (possibly across a customer account)
• Ensure timely follow-up and resolution of compliance issues.
• Serve as Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology.
• Serve as customer site lead for one or more customers.
• Train and mentor junior DTL staff in DM expertise
• May coordinate the work of more junior DTL staff.
• Independently maintain internal tracking databases and systems

Financial Management / Business Development Support :

• Independently manage SOW / budget
• Review financial reports monthly and participate in project reviews as requested.
• Identify out of scope tasks and track change orders to completion.
• Participate in pricing discussions across customer account.
• Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing.
• Independently support RFP process (review RFP documents, pricing, attend bid defense)

Other :

• Independently bring process improvements and solutions to the CDM team / CDM department
• Lead a focus team or global or local best practice team.
• Communicate lessons learned and / or present in CDM workshop(s)
• Manage the development and implementation of new technology or tool.
• Present at professional conferences and / or publish articles in professional journals.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions.
• Perform other duties as directed by the functional manager.

Qualifications

Please note that requirements for this position do not align with an Analyst, Architect Data Entry, Design, Engineering, IT, or Research role. Applicants that do not meet the requirements for the position will not be considered.

• Bachelor's Degree Health, clinical, biological, or mathematical sciences, or related field Req
• 7 years direct Data Management experience, including 5 or more years as a CDM project lead. Equivalent combination of education, training, and experience.
• Previous experience and proven competence in managing delivery of multiple global trials through full DM life cycle (i.e., large trials of at least 1000 patients).
• Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and / or new technology).
• Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently. Knowledge of Medical Terminology, Pharmacology, Anatomy, and / or Physiology.
• Knowledge of operating procedures and work instructions and the ability to apply them in practice.
• Knowledge of Good Clinical Practices and relevant regulatory guidelines.
• Comprehensive understanding of clinical drug development process.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
• Knowledge of Medical Terminology, Pharmacology, Anatomy, and / or Physiology.

Note

IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se concentre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez

IQVIA est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap, l’âge, l’état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d’adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d’adaptation, nous vous encourageons à contacter notre équipe d’acquisition de talents au

Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures, et non pas pour remplacer la prise des décisions par les membres de notre équipe.

English Version

• Job Overview
• Independently manage end-to-end delivery of data management services for single / multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, Customer Site Manager, and / or a leadership role in a specific CDM task (e.g., Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

Essential Functions

Client Management :

• Serve as primary point of contact for customer on data management deliverables.
• Manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global studies / programs of global studies Provide leadership and senior support to DTLs on multiple large global studies / programs of global studies.
• Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.
• Lead direct negotiations with customer, e.g., timelines, financial, process, resources.
• Maintain strong customer relationships.
• Ensure open communications with customer and IQVIA management to independently manage and meet contractual obligations.

Service Management :

• Meet with Data Operations Coordinator (DOC) and / or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables.
• Provide training and development on data management expertise to junior team members.
• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders.
• Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
• Serve as the escalation point for unresolved data issues.
• Independently work with client data managers, vendors, internal team members for resolution
• Ensure appropriate resources are assigned to meet project deliverables.
• Create and / or review and sign-off on all data management plan (DMP) documents.
• Ensure service and quality meet agreed upon specifications per the DMP and contract / SOW.
• Implement proactive quality management plans across multiple projects / programs / customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions.
• Continuously look for opportunities to improve service.
• Develop and work with team to implement plan to re-organize and drive change (possibly across a customer account)
• Ensure timely follow-up and resolution of compliance issues.
• Serve as Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology.
• Serve as customer site lead for one or more customers.
• Train and mentor junior DTL staff in DM expertise
• May coordinate the work of more junior DTL staff.
• Independently maintain internal tracking databases and systems

Financial Management / Business Development Support :

• Independently manage SOW / budget
• Review financial reports monthly and participate in project reviews as requested.
• Identify out of scope tasks and track change orders to completion.
• Participate in pricing discussions across customer account.
• Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing.
• Independently support RFP process (review RFP documents, pricing, attend bid defense)

Other :

• Independently bring process improvements and solutions to the CDM team / CDM department
• Lead a focus team or global or local best practice team.
• Communicate lessons learned and / or present in CDM workshop(s)
• Manage the development and implementation of new technology or tool.
• Present at professional conferences and / or publish articles in professional journals.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions.
• Perform other duties as directed by the functional manager.

Qualifications

Please note that requirements for this position do not align with an Analyst, Architect Data Entry, Design, Engineering, IT, or Research role. Applicants that do not meet the requirements for the position will not be considered.

• Bachelor's Degree Health, clinical, biological, or mathematical sciences, or related field Req
• 7 years direct Data Management experience, including 5 or more years as a CDM project lead. Equivalent combination of education, training, and experience.
• Previous experience and proven competence in managing delivery of multiple global trials through full DM life cycle (i.e., large trials of at least 1000 patients).
• Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and / or new technology).
• Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently. Knowledge of Medical Terminology, Pharmacology, Anatomy, and / or Physiology.
• Knowledge of operating procedures and work instructions and the ability to apply them in practice.
• Knowledge of Good Clinical Practices and relevant regulatory guidelines.
• Comprehensive understanding of clinical drug development process.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
• Knowledge of Medical Terminology, Pharmacology, Anatomy, and / or Physiology.

Note

IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se concentre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez

IQVIA est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap, l’âge, l’état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d’adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d’adaptation, nous vous encourageons à contacter notre équipe d’acquisition de talents au

Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures, et non pas pour remplacer la prise des décisions par les membres de notre équipe.

English Version

• Job Overview
• Independently manage end-to-end delivery of data management services for single / multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, Customer Site Manager, and / or a leadership role in a specific CDM task (e.g., Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

Essential Functions

Client Management :

• Serve as primary point of contact for customer on data management deliverables.
• Manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global studies / programs of global studies Provide leadership and senior support to DTLs on multiple large global studies / programs of global studies.
• Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.
• Lead direct negotiations with customer, e.g., timelines, financial, process, resources.
• Maintain strong customer relationships.
• Ensure open communications with customer and IQVIA management to independently manage and meet contractual obligations.

Service Management :

• Meet with Data Operations Coordinator (DOC) and / or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables.
• Provide training and development on data management expertise to junior team members.
• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders.
• Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
• Serve as the escalation point for unresolved data issues.
• Independently work with client data managers, vendors, internal team members for resolution
• Ensure appropriate resources are assigned to meet project deliverables.
• Create and / or review and sign-off on all data management plan (DMP) documents.
• Ensure service and quality meet agreed upon specifications per the DMP and contract / SOW.
• Implement proactive quality management plans across multiple projects / programs / customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions.
• Continuously look for opportunities to improve service.
• Develop and work with team to implement plan to re-organize and drive change (possibly across a customer account)
• Ensure timely follow-up and resolution of compliance issues.
• Serve as Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology.
• Serve as customer site lead for one or more customers.
• Train and mentor junior DTL staff in DM expertise
• May coordinate the work of more junior DTL staff.
• Independently maintain internal tracking databases and systems

Financial Management / Business Development Support :

• Independently manage SOW / budget
• Review financial reports monthly and participate in project reviews as requested.
• Identify out of scope tasks and track change orders to completion.
• Participate in pricing discussions across customer account.
• Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing.
• Independently support RFP process (review RFP documents, pricing, attend bid defense)

Other :

• Independently bring process improvements and solutions to the CDM team / CDM department
• Lead a focus team or global or local best practice team.
• Communicate lessons learned and / or present in CDM workshop(s)
• Manage the development and implementation of new technology or tool.
• Present at professional conferences and / or publish articles in professional journals.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions.
• Perform other duties as directed by the functional manager.

Qualifications

Please note that requirements for this position do not align with an Analyst, Architect Data Entry, Design, Engineering, IT, or Research role. Applicants that do not meet the requirements for the position will not be considered.

• Bachelor's Degree Health, clinical, biological, or mathematical sciences, or related field Req
• 7 years direct Data Management experience, including 5 or more years as a CDM project lead. Equivalent combination of education, training, and experience.
• Previous experience and proven competence in managing delivery of multiple global trials through full DM life cycle (i.e., large trials of at least 1000 patients).
• Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and / or new technology).
• Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently. Knowledge of Medical Terminology, Pharmacology, Anatomy, and / or Physiology.
• Knowledge of operating procedures and work instructions and the ability to apply them in practice.
• Knowledge of Good Clinical Practices and relevant regulatory guidelines.
• Comprehensive understanding of clinical drug development process.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
• Knowledge of Medical Terminology, Pharmacology, Anatomy, and / or Physiology.

Note

IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se concentre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez

IQVIA est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap, l’âge, l’état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d’adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d’adaptation, nous vous encourageons à contacter notre équipe d’acquisition de talents au

Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures, et non pas pour remplacer la prise des décisions par les membres de notre équipe.

English Version

• Job Overview
• Independently manage end-to-end delivery of data management services for single / multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, Customer Site Manager, and / or a leadership role in a specific CDM task (e.g., Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

Essential Functions

Client Management :

• Serve as primary point of contact for customer on data management deliverables.
• Manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global studies / programs of global studies Provide leadership and senior support to DTLs on multiple large global studies / programs of global studies.
• Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.
• Lead direct negotiations with customer, e.g., timelines, financial, process, resources.
• Maintain strong customer relationships.
• Ensure open communications with customer and IQVIA management to independently manage and meet contractual obligations.

Service Management :

• Meet with Data Operations Coordinator (DOC) and / or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables.
• Provide training and development on data management expertise to junior team members.
• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders.
• Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
• Serve as the escalation point for unresolved data issues.
• Independently work with client data managers, vendors, internal team members for resolution
• Ensure appropriate resources are assigned to meet project deliverables.
• Create and / or review and sign-off on all data management plan (DMP) documents.
• Ensure service and quality meet agreed upon specifications per the DMP and contract / SOW.
• Implement proactive quality management plans across multiple projects / programs / customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions.
• Continuously look for opportunities to improve service.
• Develop and work with team to implement plan to re-organize and drive change (possibly across a customer account)
• Ensure timely follow-up and resolution of compliance issues.
• Serve as Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology.
• Serve as customer site lead for one or more customers.
• Train and mentor junior DTL staff in DM expertise
• May coordinate the work of more junior DTL staff.
• Independently maintain internal tracking databases and systems

Financial Management / Business Development Support :

• Independently manage SOW / budget
• Review financial reports monthly and participate in project reviews as requested.
• Identify out of scope tasks and track change orders to completion.
• Participate in pricing discussions across customer account.
• Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing.
• Independently support RFP process (review RFP documents, pricing, attend bid defense)

Other :

• Independently bring process improvements and solutions to the CDM team / CDM department
• Lead a focus team or global or local best practice team.
• Communicate lessons learned and / or present in CDM workshop(s)
• Manage the development and implementation of new technology or tool.
• Present at professional conferences and / or publish articles in professional journals.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions.
• Perform other duties as directed by the functional manager.

Qualifications

Please note that requirements for this position do not align with an Analyst, Architect Data Entry, Design, Engineering, IT, or Research role. Applicants that do not meet the requirements for the position will not be considered.

• Bachelor's Degree Health, clinical, biological, or mathematical sciences, or related field Req
• 7 years direct Data Management experience, including 5 or more years as a CDM project lead. Equivalent combination of education, training, and experience.
• Previous experience and proven competence in managing delivery of multiple global trials through full DM life cycle (i.e., large trials of at least 1000 patients).
• Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation, management of local laboratory data, and / or new technology).
• Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independently. Knowledge of Medical Terminology, Pharmacology, Anatomy, and / or Physiology.
• Knowledge of operating procedures and work instructions and the ability to apply them in practice.
• Knowledge of Good Clinical Practices and relevant regulatory guidelines.
• Comprehensive understanding of clinical drug development process.
• Ability to establish and maintain effective working relationships with coworkers, managers, and customers.
• Knowledge of Medical Terminology, Pharmacology, Anatomy, and / or Physiology.

Note

IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé. IQVIA se concentre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez

IQVIA est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap, l’âge, l’état matrimonial ou tout autre statut protégé par la loi applicable. Des mesures d’adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d’adaptation, nous vous encourageons à contacter notre équipe d’acquisition de talents au

Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures, et non pas pour remplacer la prise des décisions par les membres de notre équipe.

English Version

• Job Overview
• Independently manage end-to-end delivery of data management services for single / multi-service projects, ensuring quality deliverables on time and within budget, to customer satisfaction. Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Provide leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables. May perform role of Data Team Lead (DTL), Program Lead, Customer Site Manager, and / or a leadership role in a specific CDM task (e.g., Subject Matter Expert (SME). Comply with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.

Essential Functions

Client Management :

• Serve as primary point of contact for customer on data management deliverables.
• Manage multiple large studies or program of studies (possibly global) Provide leadership and senior support to DTLs on multiple large global studies / programs of global studies Provide leadership and senior support to DTLs on multiple large global studies / programs of global studies.
• Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.
• Lead direct negotiations with customer, e.g., timelines, financial, process, resources.
• Maintain strong customer relationships.
• Ensure open communications with customer and IQVIA management to independently manage and meet contractual obligations.

Service Management :

• Meet with Data Operations Coordinator (DOC) and / or Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverables.
• Provide training and development on data management expertise to junior team members.
• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders.
• Independently manage DM service delivery with comprehensive DM process and technical expertise in executing projects
• Serve as the escalation point for unresolved data issues.
• Independently work with client data managers, vendors, internal team members for resolution
• Ensure appropriate resources are assigned to meet project deliverables.
• Create and / or review and sign-off on all data management plan (DMP) documents.
• Ensure service and quality meet agreed upon specifications per the DMP and contract / SOW.
• Implement proactive quality management plans across multiple projects / programs / customer account. Manage service performance and provide leadership to identify root causes of issues and implement remedial actions.
• Continuously look for opportunities to improve service.
• Develop and work with team to implement plan to re-organize and drive change (possibly across a customer account)
• Ensure timely follow-up and resolution of compliance issues.
• Serve as Subject Matter Expert (SME)
• Provide leadership and expertise in a specific CDM task or technology.
• Serve as customer site lead for one or more customers.
• Train and mentor junior DTL staff in DM expertise
• May coordinate the work of more junior DTL staff.
• Independently maintain internal tracking databases and systems

Financial Management / Business Development Support :

• Independently manage SOW / budget
• Review financial reports monthly and participate in project reviews as requested.
• Identify out of scope tasks and track change orders to completion.
• Participate in pricing discussions across customer account.
• Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing.
• Independently support RFP process (review RFP documents, pricing, attend bid defense)

Other :

• Independently bring process improvements and solutions to the CDM team / CDM department
• Lead a focus team or global or local best practice team.
• Communicate lessons learned and / or present in CDM workshop(s)
• Manage the development and implementation of new technology or tool.
• Present at professional conferences and / or publish articles in professional journals.
• Provide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructions.
• Perform other duties as directed by the functional manager.

Expiry

IsExpired = false