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 four areas of cancer research: Tumor Cell Targeting, Immuno-Oncology, Oncology Cell & Gene Therapy, and Synthetic Lethality.
The Clinical Trial Medical Review Team (CTMRT) is an integral part of the global Oncology Clinical Development and consists of Medical Review (MR) Scientists and MR Physicians.
CTMRT staff is seamlessly embedded withing the core study team and comprises highly valued Medical Review Subject Matter Experts (SMEs), with a strong focus on excellence in both the content and execution of in-stream medical review. The team’s primary goal is to deliver a complete, robust, and medically accurate data package.
CTMRT collaborates closely with colleagues from Oncology Clinical Development while operating from a centralized location that maintains strong connections with other local site functions.
In this role 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 or Canada - Ontario - Mississauga - Milverton Drive.
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
- Review and contribute to 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
- 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.
- 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 the data collection phase, the MR Scientist executes medical review in line with the Medical Review Plan (MRP) for which s/he is responsible as defined during the set-up phase
- Collaborate with the Centralized Monitoring team to identify key study risks based on the iterative medical review
- Accountable to the Clinical Study Team for: review of medically 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
- Support medical coders to ensure consistency and accuracy of adverse events, medical history, and concomitant medication coding
- Participate and contribute to 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 member across multiple studies
- Provide mentorship and guidance to other CTMRT members
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?
At GSK we offer a wide range of additional benefits:
Career at one of the leading global healthcare companies
Hybrid work ( 2/3 days per week from the office)
Contract of employment
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)
Possibilities of development within the role and company’s structure
Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).
Supportive community and integration events
Modern office with creative rooms, fresh fruits every day
#LI-GSK
#LI-Hybrid
As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at [email protected] to discuss your needs.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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