Clinical Data Analyst M/F

AB Science; Paris; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

Une entreprise leader dans la recherche pharmaceutique recherche un gestionnaire de données cliniques pour assurer l'intégrité et la cohérence des données essentielles aux essais cliniques. Vous contribuerez au développement et aux opérations des documents d'étude tout en travaillant en étroite collaboration avec les équipes cliniques et de pharmacovigilance. Nous recherchons un candidat diplômé, avec une forte expérience en gestion de données, prêt à relever des défis dans un environnement dynamique.

Qualifications

• Diplôme universitaire en pharmacie, pharmacologie ou sciences de la vie.
• Minimum 5 ans d'expérience en essais cliniques.
• Certification de codage MedDRA ou WHODD un plus.

Responsabilités

• Assurer la cohérence des données cliniques pour les rapports d'études.
• Développer et suivre les délais pour respecter les jalons de gestion des données.
• Participer à la formation et à la gestion des processus au sein de l'équipe de révision des données cliniques.

Connaissances

Connaissance du processus de développement clinique

Compétences en gestion de données cliniques

Collaboration et communication

Formation

Université de premier cycle en pharmacie, pharmacologie ou sciences de la vie

Outils

SQL

MS Access

SAS

Excel

Word

Power Point

Description du poste

• Ensure the clinical consistency of data used for statistical analyses and clinical study reports
• Clinical data to be check includes (but not limited to): laboratory results, adverse events, medical history, vital signs, efficacy measurements and treatments.
• Follow-up the resolution of detected issues/inconsistencies via queries process
• Participate to the development and maintenance of core study documents pertaining to the section, e.g. the CRF, CRF Completion Guidelines, Data Validation Specifications, Data Management Plan, Data Review Plan etc.
• Ensure Clinical Data Management input to other relevant strategic study documents (i.e. Data Management Operation Plan) and vendor contracts (i.e. central lab data transfer agreement)
• Detect important medical events.
• Perform reconciliation of SAE and AE of Special Interest between the Pharmacovigilance database and the Clinical Study Database.
• Detect the forbidden concomitant treatments as per study protocol.
• Develop and track timelines to ensure data management milestones are met in coordination with the Clinical and Pharmacovigilance Team.
• Archive documents in the clinical data management TMF
• Participate to the training and process management within the Clinical Data Review team.
• Support the Quality Management System (QMS) by participating in the life cycle of procedure and other applicable documents, declaring non-compliances encountered in the daily operations and following the associated corrective and preventive plans, alerting if necessary and suggesting any possible optimization of the processes.
• Function as section representative in audits and regulatory inspections.
• Ensure the completion of MedDRA and WHODD Coding of medical terms and concomitant medications in a timely manner, and, by following the company guidelines.
• Increase functional effectiveness by supporting departmental efforts to simplify and standardize procedures, sharing best practices and participating in or leading continuous improvement efforts.
• Facilitate and/or participate in management and functional area meetings, contributing expertise when necessary through formal or informal presentations.
• Support the database programming aspect of the data review plan, including programming of data review reports and regulatory documents.

Requirements

• Male or female with University degree (MSc or PhD) in Pharmacy, Pharmacology, Life Sciences or related discipline.
• At least 5 years of experience in Clinical trials, preferably in Clinical Data Management.
• Knowledge of clinical development process.
• Understanding of regulatory guidelines in a pharmaceutical research setting, including ICH GCP training.
• Sound familiarity with Office automation tool (i.e. Excel, Word, Power point)
• Knowledge of database programming tool is a plus (i.e. SQL, MS Access, SAS, etc.)
• MedDRA coding certification is a plus
• WHODD coding certification is a plus
• Based in Paris
• Salary & package to define according skills and experience