Participate in cross functional trial team meetings and Medical Monitoring focused meetings
Responsible for creation, review and maintenance of study level plans such as medical review plan and safety management plan.
Perform medical review and provide summary of data review, safety reporting and trending analysis according to medical monitoring plan and relevant SOPs.
Review adverse events for relationship to treatment. Review SAEs and support related document creation such as SUSAR/PLS, LL
Review data for medical correctness, clarity, and consistency. Review all data required for events/lab abnormalities. Query data as needed. Write draft narratives for CSR as required.
Establish relationships with clinical trial sites to discuss protocol questions and enrolment challenges
Support development of training materials for and perform training
Contribute to clinical development plans, trial protocols and takes support development of clinical study reports as required for specific trial
Plan and organize and support Eligibility and Data Adjudication Meetings as required per protocol
Maintain close interactions with Clinical Scientists and Physicians across programs
Assists the SRP for Regulatory Affairs in determining requirements for any corrective actions or health authority reporting
Reviews medical literature and related new technologies
May be asked to assess medical publications emerging from the Team and its affiliates
Qualifications
MD (or equivalent) in relevant area with appropriate post-doctoral training and board certification.
Specific experience in TA area or indications may be required (i.e. experience in Immunology related indications).
3+ years experience in the pharmaceutical industry conducting clinical trials.
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
Strong IT skills in appropriate software and company systems.
Willingness to travel with overnight stay away from home according to business needs.
Proficient in speaking and writing in English. Effective communication skills, oral and written.
