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Study Manager, Global Study Operations

San Rafael, CA 94901

Posted: 04/18/2025 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 618969 Is job remote?: Yes Country: United States

Job Description


Responsibilities include but are not limited to:
  • Overall study execution oversight
  • Provide leadership, guidance, and direction to GSO staff assigned to studies
  • Lead cross-functional Study Execution Team (SET) meetings
  • Collaborate with cross-functional study members to drive and execute on study deliverables, documents, and plans
  • Proactively identify, manage, and communicate cross functional study issues, risks and mitigations in a timely manner
  • Provide regular study quality and progress updates to key stakeholders as needed
  • Monitor and act upon study metrics; review trend-identification and analysis and provide targeted follow up where appropriate
  • Collaborate with other Study Managers to ensure consistency and maintenance of the various study plans within a program
  • Collaborate with People and Process Managers of the Study Specialist staff to support team member productivity and career growth
  • Other responsibilities Include:
    • Contribute to the Study protocol and Informed Consent Form (ICF) development
    • Management of GSO Study Timelines
    • Management of CRO and Vendors
    • Management of Study Lifecycle (start-up, enrollment, maintenance and close-out)
    • Oversight of Drug / Investigational Product (IP) process
    • Management of Study Budget
    • Oversight of Feasibility, Recruitment and Enrollment
    • Oversight of Study Outcome and Data Deliverables
  • Lead or participate in program or study-specific projects that have a wider impact
  • Collaborate with study managers/cross-functional team members to implement department process change and efficiencies

Requirements:
  • BA/BS/BSc
  • 5 years’ work experience in life sciences or medically related field, including at least 3 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical, or CRO setting.

Core:
  • Decision Making and Problem Solving
  • Influence and Organizational Awareness
  • Agility and Proactivity 
  • Leadership
  • Communication and Collaboration 

Technical
  • Data Analysis and Interpretation
  • Study Management and Execution 
  • Compliance and Quality
  • Drug Development and Study Design 
  • Product and Therapeutic Area Knowledge
  • Knowledge of managing all phases of clinical trials (Early Clinical Development/Ph 1 through Post Approval studies)

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About San Rafael, CA

Ready to take the next step in your career? Explore our job opportunities in the vibrant San Rafael, California area! Nestled in Marin County, San Rafael offers a perfect blend of picturesque landscapes, cultural attractions such as the Marin Veterans' Memorial Auditorium and the Marin History Museum, and a thriving culinary scene with diverse eateries like Sol Food and Terrapin Crossroads. This charming city also boasts easy access to outdoor adventures at China Camp State Park and opportunities to appreciate local art at the Falkirk Cultural Center. Join us in San Rafael, where career growth meets undeniable charm – apply now and discover your next career move in this dynamic region!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.