Profesor Arte 3D Para Videojuegos (Senior)

Richemont; Comunidad Valenciana; Presencial; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

An established industry player is seeking an Associate Medical Director to enhance clinical trial outcomes through expert medical leadership. In this pivotal role, you will oversee the development and implementation of clinical trial protocols, ensuring compliance with regulatory standards while addressing stakeholder concerns. Your expertise will guide study teams in delivering impactful health solutions, making a difference in communities worldwide. Join a dynamic team that values innovation, collaboration, and dedication to improving health outcomes globally.

Formación

• Proven experience in medical leadership and clinical trial management.
• Strong understanding of pharmacovigilance and regulatory compliance.

Responsabilidades

• Provide medical support and leadership for clinical trials and safety evaluations.
• Review and approve clinical study documents ensuring compliance and safety.

Conocimientos

Medical Leadership

Clinical Trial Protocol Development

Pharmacovigilance

Regulatory Compliance

Stakeholder Communication

Educación

Medical Degree

Postgraduate Qualification in Clinical Research

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 and 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 necessary for conducting trials.
3. Monitor clinical studies in real-time to ensure medical validity of primary endpoints and subject safety, identifying medical 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 regarding procedural and budgetary considerations and adapt to protocol amendments as needed.
6. Work with other functions to close gaps and resolve issues promptly and effectively.
7. Serve as the main liaison between sponsors and internal departments during all study phases.
8. Educate investigator sites by delivering protocol-specific lab procedures presentations during investigator meetings.
9. Manage daily activities during trials to resolve issues and answer queries.
10. Act as the medical point of contact for stakeholders: interact with investigators, respond to IRB and Health Authority inquiries, prepare and present materials to study committees, and provide medical training at investigator meetings and CRA training for new indications.
11. Ensure compliance with all medical aspects by adhering to SOPs and GCP guidelines.