Clinical Site Manager

Clinical Site Manager

Bristol-Myers Squibb

Solna, 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!

Responsibilities:

  • 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.

Requirements:

  • 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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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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