Study Start Up Manager, IQVIA Biotech

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

Job summary

A global leader in clinical research services is seeking a candidate for a role focused on managing site activation and regulatory activities for clinical studies. The ideal applicant should have a Bachelor's degree in Life Sciences, along with 7 years of experience in a clinical environment. Strong negotiation and communication skills are essential for ensuring successful project delivery. This position is based in Kirkland, Canada, offering a dynamic work environment.

Qualifications

• 7 years’ relevant experience in a scientific or clinical environment, including experience in an international role.
• Thorough understanding of the regulated clinical trial environment.
• Demonstrated proficiency in using systems and technology.

Responsibilities

• Direct and manage the delivery of site activation and maintenance for projects.
• Develop and maintain the Management Plan according to the Scope of Work.
• Provide regulatory strategy and solutions for submissions.

Skills

Negotiation skills

Communication skills

Team player

Leadership skills

Organizational skills

Education

Bachelor's Degree in Life Sciences or related field

Job description

Overview

At IQVIA Biotech, we partner with visionary biotech companies to transform innovation into patient impact. With dedicated teams, deep therapeutic expertise, and a biotech-tailored delivery model, we accelerate clinical development from early phase through global registrational studies.

Responsibilities

• Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.
• Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.
• Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required.
• Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.
• Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
• Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team.
• Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
• Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.
• Execute operational strategy/expectations for maintenance of clinical study approvals, authorizations and review/negotiation of contracts and essential documents.
• Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable).
• Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.
• May take a lead role in developing long standing relationships with preferred IQVIA customers.
• Deliver presentations/training to clients, colleagues and professional bodies, as required.
• May be involved in activities related to monthly study budget planning and reviews.

Qualifications

• Bachelor's Degree Life sciences or related field (Required).
• 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
• Strong negotiation and communication skills with ability to challenge.
• Excellent interpersonal skills and strong team player.
• Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects.
• Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process.
• Demonstrated proficiency in using systems and technology to achieve work objectives.
• Good regulatory and/or technical writing skills.
• Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines.
• Good leadership skills, with ability to motivate, coach and mentor.
• Good organizational and planning skills.
• Ability to exercise independent judgment taking calculated risks when making decisions.
• Good presentation skills.
• Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
• Excellent understanding of study financial management.
• Proven ability to work on multiple projects balancing competing priorities.

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 consacre 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 https://jobs.iqvia.com

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 [e-mail], afin qu’IQVIA puisse soutenir votre participation au processus de recrutement.

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at: [e-mail], so that IQVIA can support your participation in the recruitment process.

Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.