Project Director responsible for overseeing end - to - end delivery of significant programmes at Expleo. Defining, implementing and managing strategies for client projects.
About the role
- Director of Medical Review Scientist at GSK managing oncology studies with a focus on medical review and data integrity. Leading clinical data reviews and mentoring junior MR scientists.
Responsibilities
- Responsible for the medical consistency and robustness of clinical data that cannot be processed by computerized means: Iterative, in-stream, standardized data review that employs medical judgment, with intent to ensure data accurately and completely reflect the clinical course of participant(s) in the study
- Review and contribute to study-related documents such as protocols, medical monitoring plans, statistical analysis plans, data management plan, eCRFs, eCRF completion guidelines, database edit checks, risk-based monitoring plans, etc.; may contribute to site training activities and supporting the study team and CRO personnel regarding all MR-related aspects of the trial
- During study set-up phase, in collaboration with the Data Management and Clinical Development team, the MR Scientist develops a Medical Review Plan (MRP) for the study, which details the scope of the medical review and appropriate timelines s/he performs on the study data. This review requires a holistic approach within and across study participants, and a deep understanding of the study protocol, patient population, and medical knowledge. The medical review will encompass participant eligibility, protocol adherence, medical consistency, safety checks, as well as efficacy checks when appropriate. The MRP is a “living document” and will be updated and adapted as the study progresses, in collaboration with the Data Management and Clinical Development teams
- Assist in setting up medical review tools that support medical review throughout the study, such as reviewing the specifications, identifying critical variables, and performing user acceptance testing (UAT) During the data collection phase, the MR Scientist executes medical review for which s/he is responsible as defined in the MRP during the set-up phase Collaborate with the Centralized Monitoring team to identify key study risks based on the iterative medical review Support medical coders to ensure consistency and accuracy of adverse events, medical history, and concomitant medication coding Review statistical program outputs (i.e., tables, figures, and listings – or TFLs) during study to identify inconsistencies in data capture and areas that need to be addressed by the CTMRT Accountable to the Clinical Study Team for: review of medical-related protocol deviations, raising and responding to medical queries in the database, analysis of trends for data inconsistencies and flagging areas that require additional site training, etc. May be responsible for developing site training materials to address those issues Participate and contribute to weekly core study team meetings and update the teams on the status of medical review, trend analysis, etc Identifies program, trial or data risks, creates, and implements mitigation strategies in collaboration with the Clinical Study Team as appropriate Support the Data Management team in ensuring the eCRFs and eCRF completion guidelines accurately reflect the patient population under study and the scope of the protocol Require a close collaboration with the study’s Clinical Development team (i.e., Study Physician, Clinical Scientist) as well as Patient Safety to discuss/review complex medical questions and concepts
Requirements
- Bachelors in Life Science degree with 8+ years of industry and 3+ years of experience in Oncology or, in lieu, relevant clinical experience and demonstrated capabilities and experiences
- Experience with data review/interpretation, study design and the clinical development process
- Experience using electronic data capture (EDC) systems, query management, and Medical Review tools
- Knowledge of regulatory requirements to support registration, including knowledge and adherence to GCP principles
- Expert communicator (i.e., excellent command of spoken and written English) with outstanding presentation skills are essential
- Must be able to work productively in a fast-paced collaborative environment with a positive attitude.
Benefits
- Flexible working hours
- Professional development opportunities
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Tech skills
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