Ville : Toronto

Catégorie : Autre

Industrie : Healthcare

Employeur : GSK

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.

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, integrate seamlessly with the core study team and are 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 Canada, Mississauga site.  

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 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. 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 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 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 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:

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

• 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:

The following characteristics would be a plus:

• 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. 

#Li-Hybrid

Pourquoi GSK?
Allier science, technologie et talent pour vaincre ensemble la maladie.

GSK est une entreprise biopharmaceutique mondiale dont la mission est de réunir la science, la technologie et le talent pour prendre ensemble de l'avance sur les maladies. Nous visons à avoir un impact positif sur la santé de 2,5 milliards de personnes d'ici la fin de la décennie, en tant qu'entreprise prospère et en croissance où les gens peuvent s'épanouir. Nous prenons de l'avance sur les maladies en les prévenant et en les traitant grâce à l'innovation dans les médicaments spécialisés et les vaccins. Nous nous concentrons sur quatre domaines thérapeutiques : les maladies respiratoires, l'immunologie et l'inflammation; l'oncologie; le VIH; les maladies infectieuses – pour avoir un impact à grande échelle sur la santé.

Les gens et les patients partout dans le monde comptent sur les médicaments et les vaccins que nous produisons; c'est pourquoi nous nous engageons à créer un environnement où nos employés peuvent s'épanouir et se concentrer sur ce qui compte le plus. Notre culture, qui repose sur l'ambition pour les patients, la responsabilité de la portée et le fait de faire ce qui est juste, constitue la base de la manière dont nous tenons nos engagements ensemble pour les patients, les actionnaires et nos employés.

GSK est un employeur offrant l'égalité des chances. Cela garantit que tous les candidats qualifiés recevront une considération égale pour l'emploi sans distinction de race, de couleur, de religion, de sexe (y compris la grossesse, l'identité de genre et l'orientation sexuelle), de statut parental, d'origine nationale, d'âge, de handicap, d'informations génétiques (y compris les antécédents médicaux familiaux), de service militaire ou de toute autre base interdite par la loi fédérale, étatique ou locale. GSK s'engage à accueillir les personnes handicapées. Si vous avez besoin d'un aménagement à n'importe quelle étape du processus de candidature ou si vous souhaitez plus d'informations sur nos politiques d'aménagement, veuillez nous contacter à canada-recruitment@gsk.com. Veuillez ne pas envoyer de CV à cette adresse e-mail et postuler plutôt via le processus de candidature en ligne de cette annonce.

Avis important destiné aux services/agences de placement

GSK n’accepte pas les propositions des services/agences de placement en vue de pourvoir les postes affichés dans le présent site. Ces services/agences doivent s’adresser au service d’approvisionnement/des ressources humaines de GSK pour obtenir une autorisation écrite avant de lui proposer des candidats. Cette autorisation est une condition préalable à toute entente (orale ou écrite) entre le service/l’agence de placement et GSK. Sans cette autorisation écrite, toute mesure de la part du service/de l’agence de placement doit être considérée comme avoir été appliquée sans le consentement ni l’entente contractuelle de GSK. Par conséquent, GSK ne peut pas être tenue responsable des honoraires attribuables à de telles mesures ni à quelque recommandation que ce soit de la part du service/de l’agence de placement en ce qui concerne sa proposition de candidature en vue de pouvoir un poste annoncé dans le présent site.