Bristol Myers Squibb Clinical Site Manager in Solna (Sweden), Sweden
Bristol-Myers Squibb is looking for a Clinical Site Manager to drive and support the clinical trials within the Nordics region. R&D suppose a key point in our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases – the person working on this innovative development in the pharmaceutical industry could be you!
Manage all steps in a clinical trial execution from country profiling, site feasibility and site selection, target setting, hub commitment, study start-up, site activation, study recruitment & maintenance and database lock to final study closure.
Effectively applies project management skills, uses available tools and systems to gather information needed to manage study activities.
Managing and/ or coordinating the submission of initial and ongoing documents to the relevant IRB/MOH and/or other regulatory bodies for approval or acknowledgment.
Effectively coordinates Hub cross functional teams and acts as the main point of contact for a Hub with internal and external stakeholders.
Ensure Hub is Inspection ready and prepares the CAPA for Hub audit level findings. Drives CAPA review and implementation.
Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
Ensures database locks are met at a site and appropriate site management support for central teams during Database Locks.
Leads/ drive issue and risk management at site, country and study level, set up contingency plans and escalate to the appropriate internal and/ or external stakeholders.
Works closely with other study team members in the coordination of study activities to meet the appropriate timelines at the site/protocol level and escalate as needed witch could have impact on the overall protocol timelines.
Adapts well to ambiguous and complex work environment, balancing multiple tasks and prioritize effectively.
Bachelor’s degree in Science or similar
Similar experience working as a Site Manager or Senior CRA within the pharmaceutical industry
Project management skills
Knowledge of ICH-GCP is required
Good oral and written English communication skills
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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.