Job Title: Associate Medical Director- Oncology ,Sponsor-Dedicated (m/w/d)
Job Location: Frankfurt/Main, Germany
Job Location Type: Home-based
Job Contract Type: Full time
Job Seniority Level:
The Study Physician is a critical global role responsible for assuming medical oversight of clinical trials within Clinical Development & Operations. This position requires a qualified and clinically experienced physician who will provide comprehensive medical expertise throughout all phases of the trial—from preparation and conduct to reporting. The Study Physician ensures state-of-the-art medical oversight from the Trial Design Outline (TDO) kickoff through to the Clinical Trial Report (CTR) and serves as a core member of both the Trial Team and the Evidence Network Team.
Study Physician services
Medical Content Oversight:
- Responsible for medical content in Clinical Trial Protocols (CTPs).
- Collaborates with Project Management, Patient Safety, Medical Writers, and trial/evidence teams.
- Provides medical input for CTP updates.
Risk-Based Quality Management:
- Defines medically critical data/processes and associated risks.
- Contributes to Integrated Quality and Risk Management Plan (IQRMP).
- Participates in risk discussions during trial conduct.
Clinical Quality Monitoring:
- Co-authors Clinical Quality Monitoring Plan (CQMP).
- Aligns CQMP with IQRMP-identified risks and mitigations.
Protocol Deviations Management:
- Provides medical input on important protocol deviations (iPDs).
- Reviews and supports decisions on iPDs using advanced systems.
Clinical Quality Communication:
- Proactively addresses and communicates clinical quality issues.
Trial Documentation and Milestones:
- Contributes to timely preparation of core trial documents and milestones.
Data Management Input:
- Designs eCRFs and translates medical questions into electronic data capture.
- Develops “Information for CRF Completion” (ICC) and Data Review Plans.
- Specifies lab parameters and contributes to Data Transfer Agreements and alerts.
Patient-Facing and Trial-Level Documents:
Responsible for medical content in Patient Information and Informed Consent, Trial Monitoring Manual, Communication and Training Plans and Trial Statistical Analysis Plan (TSAP)
Reporting and Narratives:
Contributes to Patient Narrative preparation.
Participates in planning and reviewing medical sections of Clinical Trial Reports.
Qualifications
Medical degree from an accredited and internationally recognized medical school.
Typically requires a minimum of 5-7 years' experience in clinical medicine.
Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
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 committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
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