Principal Investigator (Lübeck)
Key Responsibilities
- Act as Principal Investigator across Phase I-IV clinical trials, with a particular focus on vaccine studies.
- Provide medical leadership and oversight throughout the full clinical trial lifecycle.
- Ensure participant safety, welfare, and protocol compliance at all times.
- Conduct and supervise screening, enrolment, eligibility assessments, and study visits.
- Review adverse events, serious adverse events, and safety data.
- Ensure studies are conducted in accordance with ICH-GCP, local regulations, and sponsor requirements.
- Maintain oversight of source documentation, data quality, and protocol adherence.
- Collaborate closely with Clinical Research Coordinators, Study Nurses, Sub-Investigators, and Clinical Operations teams.
- Participate in sponsor meetings, site visits, audits, and regulatory inspections.
- Support patient recruitment and retention strategies.
- Contribute to site growth initiatives and evaluation of future research opportunities.
- Mentor junior investigators and clinical research staff where appropriate.
Requirements
Essential
- Medical Doctor (MD) qualification.
- Full medical registration/licensure in Germany or eligibility to practice.
- Previous experience in clinical research as a Principal Investigator, Sub-Investigator, or Research Physician.
- Strong understanding of ICH-GCP guidelines and clinical trial regulations.
- Ability to make sound medical decisions in a research environment.
- Excellent communication and stakeholder-management skills.
- Fluent English language skills.
Desirable
- Experience within vaccine, infectious disease, immunology, public health, or preventative medicine studies.
- Prior responsibility for participant safety review and adverse event assessment.
- Experience interacting with sponsors, CROs, ethics committees, and regulatory authorities.
- GCP certification.
- German language skills.
What Is Offered
- Salary up to €135,000 per annum.
- Opportunity to work on a high-profile vaccine programme with significant public health impact.
- Established clinical research infrastructure and dedicated site support.
- Exposure to cutting-edge vaccine development and international sponsors.
- Strong long-term career progression opportunities within clinical research leadership.
- Collaborative and scientifically driven working environment.
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