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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting with heart? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people with heart.

Senior Study Manager (FSP)

Job ID 72253BR United Kingdom - Any Region - Home Based
The Senior Study Manager (SSM) has responsibility for one or more studies of moderate complexity generally with responsibility for all study management aspects of assigned studies
  • The SSM leads and manages the tactical execution of one or more clinical studies from study startup through database release and inspection readiness to ensure timely delivery of quality study data.
  • The SSM provides quality oversight to the Contract Research Organization (CRO) and of the CRO deliverables related to study execution
  • The SSM may also input to and support compilation of sections to Clinical Study Reports
  • The SSM will provide leadership to the teams in the setting of realistic recruitment targets and delivery milestones as the single point of accountability for detailed study start-up and monitoring plans and for delivery to the agreed plans
  • The SSM is a core member of the Study Team and will represent the CRO on matters of study execution
  • The SSM works with functional lines and directly with CRO line functions to resolve or triage site level issues
  • The SSM will drive decision making and work closely with the Clinical Study Team Lead (CSTL) to provide input to operational strategy
  • For studies where more than one SSM is assigned, may be required to act as ‘lead’ SSM and will coordinate activities of the other SSMs assigned

Qualifications

Role Requirements:
  • BS/Nurse – minimum of 5 years relevant experience
  • MS/PhD – minimum of 3 years relevant experience
  • Extensive global clinical trial/study management experience
  • Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations
  • Demonstrated study management/leadership experience
  • Demonstrated oversight of CROs
  • Demonstrated experience in managing per subject costs, vendor and ancillary, and monitoring costs projections and spend
  • Understands how to work with vendors to accomplish tasks
  • Ability to interpret study level data and translate and identify risks
  • Ability to proactively identify and mitigate risks around site level in study execution
  • Understands feasibility of protocol implementation
  • Country level cultural awareness and strong interpersonal skills
  • Keen problem-solving skills
  • Excellent communication skills, both written and verbal
  • Must be fluent in English
  • Detail oriented and possesses technical expertise (e.g., spreadsheets, metrics, and data flow management)

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