Job Title: Clinical Research Physician / Principal Investigator (Internal Medicine – Diabetes & Gastroenterology)
Location: Germany (Site-based or hybrid depending on trial location)
Employment Type: Contract position offering between 12-24 hours.
Start Date: Immediately
About the Role:
We are seeking an experienced Clinical Research Physician to act as the Principal Investigator (PI) for a clinical trial in internal medicine, with a particular focus on diabetes and gastrointestinal disorders. The successful candidate will provide medical oversight, ensure compliance with clinical protocols, and safeguard patient safety throughout the duration of the study.
Key Responsibilities:
* Serve as Principal Investigator (PI) for a clinical trial conducted in Germany, focused on diabetes and gastroenterological conditions.
* Provide medical leadership and oversight of all aspects of the clinical trial, including patient recruitment, informed consent, protocol adherence, and safety monitoring.
* Act as the primary medical point of contact for regulatory bodies, ethics committees, and sponsor representatives.
* Oversee and ensure the accuracy and completeness of clinical documentation, including Case Report Forms (CRFs), source data, and adverse event reporting.
* Collaborate with internal and external stakeholders, including site staff, monitors, CROs, and sponsor medical teams.
* Ensure compliance with GCP, ICH, local regulatory requirements, and institutional SOPs.
* Participate in feasibility assessments, site initiation, monitoring visits, and audits as required.
* Lead or support medical review meetings and contribute to the interpretation of clinical trial data.
Qualifications:
* Medical Degree (MD or equivalent) with full registration and license to practice medicine in Germany.
* Board certification in Internal Medicine, Endocrinology, Gastroenterology, or a related field is highly desirable.
* Prior experience acting as Principal Investigator or Sub-Investigator in interventional clinical trials.
* Strong understanding of Good Clinical Practice (GCP) and relevant regulatory guidelines.
* Excellent clinical judgment and ability to assess benefit-risk balance in patient care within the clinical trial context.
* Strong communication and interpersonal skills in both German and English (written and spoken).
Preferred Experience:
* Previous experience in clinical research related to diabetes and/or gastrointestinal disorders.
* Familiarity with electronic data capture (EDC) systems and clinical trial documentation standards.
* Experience in collaborating with CROs or sponsors in a trial setting.