Senior Project Manager (Madrid / Valencia / Remote)

buscojobs España; Valencia; A distancia; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

A leading global company is seeking an Associate Medical Director to provide essential medical support for clinical trials within the Pharmacovigilance department. This role involves overseeing study protocols, ensuring compliance with medical standards, and acting as a liaison between sponsors and internal teams. The ideal candidate will have a medical degree and experience in clinical research, contributing to impactful health outcomes.

Formación

• Experience in clinical trials and pharmacovigilance.
• Strong understanding of GCP guidelines and SOPs.
• Ability to lead and educate teams effectively.

Responsabilidades

• Provide medical leadership to study teams and create clinical trial protocols.
• Review and approve clinical documents required for trials.
• Monitor clinical studies to ensure subject safety.

Conocimientos

Medical Leadership

Clinical Trial Protocols

Safety Evaluation

Regulatory Compliance

Educación

Medical Degree

Descripción del empleo

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale.

Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer.

We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies.

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital, and decentralized clinical trial services.

Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Discover Impactful Work: The (Associate) Medical Director will provide medical support and advice for clinical trials and safety evaluation within the PPD Pharmacovigilance department.

A Day in the Life :

1. Provide medical leadership to study teams, including creating clinical trial protocols while implementing the latest scientific information.
2. Review and approve study protocols, amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviations, and other clinical documents required for conducting trials.
3. Monitor clinical studies in real-time to ensure medical validity of primary endpoints and subject safety, identifying issues early.
4. Address customer concerns proactively and correct issues in consultation with the Global Medical Indication Lead.
5. During protocol review, collaborate with internal teams on procedural and budgetary considerations, especially regarding amendments.
6. Work with other functions to close gaps and address issues promptly and effectively.
7. Serve as the primary liaison between the sponsor and internal departments during all study phases.
8. Educate investigator sites through protocol-specific lab procedures presentations at investigator meetings.
9. Manage daily activities during clinical trials to resolve issues and answer queries.
10. Act as the medical contact for stakeholders: interact with investigators, respond to IRB and Health Authority questions, prepare and present materials to study committees, and train site staff and CRAs on new indications.
11. Ensure compliance with all medical aspects by adhering to SOPs and GCP guidelines.