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Study Manager, Global Study OperationsMedasource • San Rafael, CA
Study Manager, Global Study Operations

Study Manager, Global Study Operations

Medasource • San Rafael, CA
30+ days ago
Job type
  • Permanent
  • Temporary
Job description

Position: Study Manager, Global Study Operations

Location: Remote

Contract Duration: 6-month contract with high likelihood of extension up to 2 years

Start Date: ASAP

Key Responsibilities:

  • 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

Qualifications:

  • 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.

Study Manager, Global Study Operations San Rafael, CA

For over 16 years, Medasource has established and maintained relationships that are designed to meet your IT staffing needs. Whether it’s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company’s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Medasource finds the people best-suited for your business. When you work with us, we work with you. That’s the Medasource promise.

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Study Manager, Global Study Operations • San Rafael, CA

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