Bristol Myers Squibb Clinical Site Manager in Uxbridge, United Kingdom
Bristol Myers Squibb (BMS) has one of the richest biopharmaceutical pipelines in the industry. We are a company that is forward thinking, a company in which diversity and inclusion are at the forefront of how we view our talent and how we work. Our science is second to none and our core behaviours enable us to perform our role with Passion, Innovation, Speed and Accountability. Bristol-Myers Squibb is looking for a Clinical Site Manager based in Uxbridge, UK.
The Clinical Site Manager role is responsible for the successful delivery of clinical trials run in the UK, Belgium, the Netherlands and Ireland. The role covers the operational management of the study locally, ensuring adherence to internal and external study requirements. Key point of contact for study communication with clinical trial sites, Site Monitors, CTAs, Global Project Manager, Regulatory and Medical departments.
o Oversees local project team, communicating key study information (globally or on a country level) between appropriate team members e.g. Site Monitors, Site Managers, Clinical Trial Associates, Line Managers, Hub Unit Manager, and Protocol Manager to ensure that site management activities, protocol execution and study documentation are in compliance with study timelines, ICH-GCP guidelines, BMS SOPs and local regulatory guidelines or regulations.
o Responsible for recruitment and timeline target setting at country level for assigned studies.
o Coordinates site selection activities by providing guidance and by collaboration with other key stakeholders (e.g. Medical, Line Managers and Hub Unit Manager, Clinical Trial Assistant, Contract Administrators and Site Monitor(s))
o Manages country level and site level budgets and payments including study related invoice approval and quarterly reconciliation of study budgets.
o Oversight of site and country level electronic study file including periodic review to ensure documents are accurate and complete.
o Actively participates and presents in Investigator Meetings and/or Site Initiation Visits as required.
o Prepares the CAPA for site audits. Drives their review and implementation.
o Co-monitors sites as required, especially prior to audits and inspections.
o Reviews Visit reports and takes action within the timelines specified, resolving and/or escalating issues appropriately.
o Proactively identifies and resolves issues noted during site management which impact the overall protocol timelines and informs the appropriate BMS team members and coordinates follow-up.
o Responsible for ethics submission documentation including drafting of application forms and Informed Consent Forms, ensuring all appropriate reviews and approvals are in place.
o Effectively coordinates with other departments: regulatory, pharmacovigilance, medical, drug supply, external vendors etc, as required.
o Effectively uses available tools and systems to gather information needed to manage site and study activities, generate reports to provide feedback to the appropriate BMS team members (e.g. Site Monitor(s), Line Managers, Hub Unit Manager, Protocol Manager and Medical Monitor).
o Provides on-going training and mentoring to team members using informal and/or formal presentations. Serves as a resource for colleagues. Understands how the issues of a single study can impact the overall project and contributes to establishment of best practices through coaching and feedback.
o Leads or participates as an active member of cross functional teams, task forces, or local and global initiatives
Successful candidate will:
o Have a thorough understanding of all aspects of the clinical research process.
o Have a thorough understanding of ICH-GCP guidelines and European regulatory guidelines or regulations as they apply to protocol/site management.
o Be able to effectively apply project management skills to plan for study milestones and keep all stakeholders informed of study progress.
o Adapt well to ambiguous and complex work environment, balancing multiple priorities. Able to multi task, manage time and prioritize effectively
o Be skilled in the use of technology (Outlook, Word, Excel, Powerpoint, EDC, eTMF, CTMS, IVRS/IRT etc).
o Have a Bachelor’s degree in Life Sciences, Allied Health, Pharmacy, Nursing and clinically related or relevant experience.
Why should you apply:
o You will help patients in their fight against serious diseases.
o You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
o You’ll get a very competitive salary and a great benefits package including an annual bonus, pension contribution, family health insurance, 25 days annual leave, life insurance, on site gym and gain-sharing bonus.
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We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.