Clinical Research Medical Advisor

Copenhagen, Denmark (Hybrid) #LI Hybrid

We are seeking a Clinical Research Medical Advisor to provide clinical strategic and tactical leadership in the country to support GDD trials, clinical development plans which change the world, concept sheets/protocols and other clinical documents. You will closely collaborate with the Trial Monitoring Organisation and Medical Affairs to ensure successful allocation, fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and mitigation plan.

This role will work directly with the GDD CD&A/Clinical Execution/CRMA team and reports to the Clinical Research Medical Head.

Key Responsibilities:
• Managing and day-to-day support provided in program/trial level quality issues, deviations and quality events management.
• Co-owning start-up phase and the recruitment plan for development clinical trials with the local TMO organization.
• Providing robust indication and protocol training to CRAs and CSEs, and other functions in the country as needed.
• Providing protocol, Risk management plan & disease training as appropriate, and externally at Investigator’s Meetings or scientific venues to support recruitment and trial awareness.
• Assessing the clinical feasibility of implementing a clinical trial protocol based on regional/local medical practice using physician interviews, local databases (RWE, payer data, patient association feed-back, etc.) and analysis of the competitive environment.
• Reviewing country or site specific Informed Consent Forms (ICF) and ensure accuracy of translation of information related to Development clinical trials /NIBR PoC studies when translated into the local language, including the patient narrative where appropriate.