Clinical Study Manager

Remote - United States

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Did you know?

Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.

Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit www.fortrea.com .

Why settle for one thing when you can have everything? Fortrea gives you the best two for one opportunity for career growth. Who doesn’t want twice the perks - working at one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus.

Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. Our reach is global - extending to 60+ countries making us one of the largest FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you.

We are seeking a Clinical Study Manager who will support team with study budget planning and management and accountable for external spend related to study execution.

Responsibilities

• Works closely with Clinical Operations Program Leader(s), Global Program Management, and Finance to ensure on a regular basis that budgets, enrollment, and gaiting are accurate
  
• Communicates study status, cost and issues to Clinical Operations Program Lead(s); serve as escalation point for third party vendors managed by Strategic Partner and/or other CROs
  
• Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner/CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted
  
• Specific areas of sponsor oversight include, but are not limited to:
  
  o Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring
  
  o Conduct Oversight Monitoring Visits, as applicable
  
  o Review and endorsement of relevant study plans, as applicable
  
  o Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes
  
  o Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study
  
  o Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies
  
  o Review and ownership of trial operational data (e.g. CTMS)
  
  o Reviewing and oversight of internal trial reports
  
• In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and CSR.
  
• Ensure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.
  
• Site relationship management
  
  

Requirements :

• Bachelor’s Degree or international equivalent required ; Life Sciences preferred
  
• 5+ years’ experience in pharmaceutical industry and/or clinical research organization, including 3+ years of clinical study management/oversight, including significant study management support experience
  
• Experience in either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs
  
• Experience in more than one therapeutic area preferred
  
• Knowledge in global regulatory and compliance requirements for clinical research, including US CFR , EU CTD , and ICH GCP
  
• Awareness of local country requirements also required
  
• Demonstrated successful experience in project/program management and matrix leadership E.g. timeline/budget management
  
• Vendor selection and oversight experience required
  
• Patient enrollment and oversight experience required
  
• Experience leading inspection readiness required
  
• Experience leading study close-out required
  
• Effective communication skills
  
• Excellent teamwork, organizational, interpersonal, and problem-solving skills
  
• Fluent business English (oral and written)
  
  

Travel Requirements:

• Up to 20 % travel, including overnight and international travel required
  
  

Pay Range: $129,000 - $165,000/year

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable. For more detailed information, please click here .

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