Closely collaborates with the Trial Monitoring Organisation to ensure fast clinical trial start up, recruitment according to planned timelines, early identification of potential delays and robust recruitment mitigation plan. Co-own start-up phase and the recruitment plan for development clinical trials with the local TMO organization.
Provides robust indication and protocol training to CRAs and CSEs, and other functions in the country as needed; Provide protocol, Risk management plan & disease training as appropriate, and externally at Investigator s Meetings or scientific venues to support recruitment and trial awareness.
Assess 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 feedback, etc.) and analysis of the competitive environment
Provide medical/clinical assistance to TMO and site for IEC/IRB Interactions; Support Ministry of Health interaction (or local Board of Health) as required
Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical/clinical input as appropriate as this relates to global development clinical trials and NIBR PoC trials.
Support planning, implementation and follow-up of regulatory agency inspections and internal audits
Review and try to resolve local medical issues / questions and, if feasible, support TMO with recruitment/ operational issues that arise during the entire course of the study - if necessary support the discussion of issues to global teams.
Perform local AE review for development compounds and provide general medical support for safety issues
Role Requirements
At least 3 Years clinical development experience in pharmaceutical industry
Sound understanding of the overall clinical development and ICH/GCP
Ability to manage a study from the medical/clinical perspective, and a demonstrated capability to problem solve and mediate complex clinical / medical / operational issues
Agility to move fast across different therapeutic areas and indications Scientific degree (medical degree highly desirable);
Trained in relevant aspects of clinical drug development including GCP, local regulatory requirements and data privacy laws. Subspecialty training desirable, but not required.
