Study Physician

Required skills

A physician trained in a clinical setting is required, with few years of active clinical practice; a medical thesis and a specialization in internal medicine or general practice are desirable First experience in the pharmaceutical industry or a CRO in medical or project related functions, ideally in Clinical Development or Clinical Operations, is an advantage Strong understanding of Health Authority regulations, the BI Code of Conduct, Corporate Medicine SOPs and major industry association codes is expected First experience with ICHGCP and relevant regulatory guidance is valuable; experience as a clinical trial investigator is an additional asset Strong ability to set direction, innovate, and communicate in a global environment with diverse internal and external stakeholders

Responsibilities

provide end-to-end medical support, guiding all clinical trial activities from TDO kickoff to the final Clinical Trial Report, and ensuring consistently high medical quality; manage the medical content of Clinical Trial Protocols, collaborating closely with CTL, CPL, Patient Safety and the trial team to deliver accurate, compliant, and scientifically strong CTPs; define trial specific clinical quality monitoring concepts, contribute to project standards, and identify critical data and processes for risk-based quality management within the Integrated Quality and Risk Management Plan; be accountable for the medical content of key study documents, including the Trial Communication Plan, Trial Training Plan and Vendor Oversight Plan; ensure medical accuracy in protocol deviation reviews and CQMP execution; lead ongoing medical data review, provide input into eCRF design, automated query rules, patient information, informed consent materials, and laboratory alert settings; be the main contact person for medical queries, supporting feasibility, recruitment and retention, contributing to regulatory responses, and preparing medical content for adjudication processes, DSMB interactions, and Steering Committee meetings

Seniority

Domain

Clinical Development – Therapeutic Areas