Associate Director, Medical Review Scientist

Site Name: Warsaw Posted Date: Feb 14 2023 GSK is expanding the Oncology Clinical Development organization and we are seeking experienced professionals to join our exciting journey. GSK Oncology has a commitment to the discovery and development of new oncology therapies with the life-changing potential of helping patients with cancer, specifically in three areas of cancer research: Tumor Cell Targeting, Immuno-Oncology and Synthetic Lethality. Oncology Clinical Development is further expanding a specialized Clinical Trial Medical Review Team (CTMRT) that is wholly integrated within the global Oncology Clinical Development function and is composed of Medical Review (MR) Scientists and MR Physicians. CTMRT staff, composed of Clinical Scientists and Physicians, is integrated seamlessly with the core study team and is highly valued Medical Review subject matter experts (SMEs) with a focus on excellence in content and delivery of instream medical review with the goal of delivering a complete, robust, and medically accurate data package. The CTMRT works with fellow Oncology Clinical Development staff from a centralized work location that has close ties with other functions located at the local site. In this role as an Associate Director, MR Scientist you will be responsible for performing medical review activities across multiple oncology studies with a wide range of therapeutic modalities and tumor types. This role will be based at the GSK Warsaw, Poland site. You can learn more about the GSK Poland Hub here This role will give YOU the opportunity to work on key activities to progress YOUR career, these responsibilities include some of the following: 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 Collaborate with the Centralized Monitoring team to identify key study risks based on the iterative medical review During the data collection phase, the MR Scientist executes medical review in line with the MRP for which s/he is responsible as defined during the set-up phase Assist in setting up medical review tools that will support medical review throughout the study, such as reviewing the specifications, identifying critical variables, and performing user acceptance testing (UAT) During study set-up phase, in collaboration with Data Management and the 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 will perform 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 Review study-related documents such as: Protocol, Data Management Plan, eCRFs and eCRF completion guidelines, database edit checks, etc. Support study team regarding all MR-related aspects of trial, including studies completed by external CRO vendor 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 issues identified Participate and contribute to weekly core study team meetings and update the teams on the status of medical review, trend analysis, etc 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 to discuss/review complex medical questions and concepts as needed May participate in writing initial Clinical Study Report narratives or narratives in support of an Independent Data Monitoring Committee (IDMC) Manage timelines and deliverables as the CTMRT team member across multiple studies Why you? Basic Qualifications: Bachelors in Life Science degree with 5+ years of industry 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 and adherence to Good Clinical Practice principles Proficient communicator (i.e., good command of spoken and written English) with excellent presentation skills Must be able to work productively in a fast-paced collaborative team environment with a positive attitude Demonstrated track record of quality decision-making and creative problem resolution in critical situations, based on assessment of all relevant supporting and conflicting information/factors and understanding of the wider context; willingness to think out of the box Preferred Qualifications: Advanced degree (e.g. MS, PhD, PharmD) or equivalent experience Oncology clinical development experience Advanced understanding of clinical development and/or marketed support to recommend, influence, and implement improvements to processes Why GSK? We also offer: Contract of employment Career at one of the leading global healthcare companies Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit) Company Car Life insurance and pension plan Private medical package with additional preventive healthcare services for employees and their eligible Sports cards (Multisport)
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