Clinical Trial Physician – Phase I, EMEA
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Job Description
Clinical Trial Physician providing medical leadership for phase I trials at Thermo Fisher Scientific. Monitoring study safety, interpreting clinical data, and guiding cross-functional teams.
Responsibilities:
- Provide medical leadership to study teams
- Create clinical trial protocols using the latest scientific information
- Contribute to site selection and review and approval of study protocols and amendments
- Review Clinical Study Reports, Informed Consent Forms, Case Report Forms, protocol deviation decisions, and other clinical documents
- Conduct real-time medical monitoring of clinical studies
- Ensure medical validity of primary endpoints and study subject safety
- Identify, escalate, and correct medical issues in consultation with the Global Medical Indication Lead
- Interpret clinical trial data for regulatory documents, manuscripts, and other publications
- Act as medical point of contact for internal and external stakeholders
- Interact with investigators and answer IRB and Health Authority questions
- Prepare and present material to study executives and independent safety committees when applicable
- Provide medical training to site staff and CRA training in new indications
- Ensure study compliance for medical aspects by applying SOPs and GCP
- Collaborate with cross-functional study team members on medical risks, issues, and results
- Harmonize site/IRB/RA answers, eligibility decisions, and protocol deviation decisions when multiple physicians work on a protocol
Requirements:
- Medical Doctor
- Relevant specialty education preferred, such as neurology, hematology, dermatology, immunology, rheumatology, internal medicine, or pediatrics
- Some experience in industry preferred
- Excellent English, written and spoken
- Ability to travel
- Proven interpersonal skills to lead a study team and provide medical advice and evaluations
- Proactive problem-solving and negotiation skills
- Sensitivity to different cultural needs in a global organization
- Strong communication and collaboration skills
- Ability to gather decision information, negotiate, and communicate decisions and actions
- Understanding and application of relevant SOPs and GCP
Benefits:
- Healthy and balanced work environment
- Collaboration and development opportunities
- Ability to work as part of a global team
- Meaningful work contributing to life-changing therapies and improved health outcomes
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