Clinical Trial Physician - Phase I (Client-Dedicated), EMEA
Thermo Fisher Scientific
Description du poste
About the role
Thermo Fisher Scientific is hiring a Clinical Trial Physician for a client-dedicated Phase I study in EMEA. The role provides medical leadership to the study team, working closely with a cross-functional team to deliver reliable, high-quality study data within time and budget. The schedule is standard (Monday to Friday) and the work is done from the office.
Key responsibilities
- Create clinical trial protocols and contribute to site selection, and take part in reviewing and approving protocols, amendments, CSRs, ICFs, CRFs, protocol deviation decisions and other clinical documents.
- Monitor studies in real time: ensure the medical validity of each primary endpoint and subject safety, escalate issues early with the Global Medical Indication Lead, and interpret data for regulatory documents, manuscripts and publications.
- Act as medical point of contact for internal and external stakeholders: interact with investigators, answer IRB and health authority questions, train site staff and CROs at investigator meetings, and present to the study executive and independent safety committee.
- Ensure study compliance with medical aspects by applying relevant SOPs and GCP, and collaborate with the study team so risks, issues and results are clear to everyone.
- If more than one physician works on the protocol, act as primus inter pares and harmonise answers to site and IRB questions, eligibility and protocol deviation decisions.
Required profile
- Medical doctor; relevant specialty education preferred (neurology, haematology, dermatology, immunology, rheumatology, internal medicine, paediatrics).
- Some industry experience preferred.
- Excellent written and spoken English and the ability to travel.
Required skills
- Proven ability to lead a study team, give medical advice and exercise judgement on what to escalate.
- Problem-solving, negotiation and strong communication skills, including in a matrix organisation.
- Sensitivity to the cultural needs of a global organisation.
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