This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
Review and oversight of the adequacy of other clinical assessments (as appropriate)
Clinical development plan, clinical protocol development, study planning and initiation
Provide medical input during development and updates to the clinical development plan
Provide medical input during clinical protocol development and Informed Consent Document (ICD)
Medical review of country feedback during protocol feasibility to ensure understanding and mitigation of any feedback which may impact future protocol compliance, risks to subject safety or data integrity
Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level
Provide medical input to the study team for study specific control plans
Ensure medical requirements are accurately defined during CRO/vendor selection to ensure study is conducted consistent with protocol requirements and/or clinical development plan expectations
Develop and maintain peer to peer relationships with healthcare professionals at clinical trial sites
Participate and lead site staff training or retraining when medical input is required
Interact with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level
Act as a point of contact for medical questions at site level and responsible for clarifications to site personnel to interpretation of protocol and knowledge of medical practice
Participate in medical interactions with opinion leaders, regulatory agencies, payers in development of clinical plan and protocols
Interact with data monitoring committees, end point adjudication committees, steering committees when medical questions/problems are surfaced which require feedback input from the study team
Develop, participate and lead study team training or retraining when medical input is required
Conduct medical review and interpretation of efficacy and safety data during study conduct
Oversight and as necessary remediation of risks identified during risk assessment and mitigation planning which require oversight by a medically qualified individual
Provide project team with medical advice for other program related activities which are not related to a specific clinical study
Review on regular basis SAE reports for early identification of potential safety issues
Liaise regularly with RMMs when assigned to the study to ensure knowledge sharing and global consistency in medical oversight activities
Medical review of efficacy and safety data in support of development of top-line report and clinical study report in collaboration with the study team
Provide medical advice and oversight to the study team or clinical program in response to audits or inspections
May co-author abstracts, posters, presentation sand publications
Requirements:
M.D. or equivalent medical qualification (refer to Global Clinical Leadership Team definition of ‘medically qualified individual’)
Proven ability to get results in a matrixed management environment
Knowledgeable of the commercial and environmental issues that drive clinical programs
Regulatory awareness – proven track record of proactive management of regulatory issues related to protocols and programs, including comprehensive experience of interactions with regulatory authorities