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Chief Medical Review Strategist

2 tygodni temu

Warszawa, Mazovia, Polska GlaxoSmithKline Pełny etat

Job Overview

We are seeking a highly skilled and experienced Director, Medical Review Scientist to join our Oncology Clinical Development organization. This is an exciting opportunity to work on key activities that progress your career and contribute to the discovery and development of new oncology therapies.

About the Role

The successful candidate will be responsible for performing medical review activities across multiple oncology studies with a wide range of therapeutic modalities and tumor types. You will also mentor Associate Director MR Scientists and collaborate with fellow Oncology Clinical Development staff from a centralized work location.

Key Responsibilities

  1. Responsible for the medical consistency and robustness of clinical data that cannot be processed by computerized means.
  2. 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.
  3. 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.
  4. 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.
  5. Collaborates with the Data Management and Clinical Development team to identify program, trial or data risks, creates, and implements mitigation strategies.
  6. Supports 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.
  7. Requires 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.

Why You?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  1. Bachelors or Masters 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.
  2. Experience with data review/interpretation, study design and the clinical development process.
  3. Expert communicator (i.e., excellent command of spoken and written English) with outstanding presentation skills are essential.
  4. Must be able to work productively in a fast-paced collaborative environment with a positive attitude.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  1. Advanced degree (e.g. PhD, PharmD) or 10+ year of experience or, in lieu, relevant clinical experience and demonstrated capabilities and experiences.
  2. Advanced understanding of clinical development and/or marketed support to recommend, influence, and implement improvements to processes.