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Study Manager, Global Study Operations

Job ID: 25-08285
Job Title: Study Manager, Global Study Operations
Duration: 12 months, 40 hrs/week
Location: San Rafael, CA; Hybrid/Remote

This role can be either in house (San Rafael-based), hybrid, or remote.
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

Within the role the candidate is expected to show and have proficiency and experience in the following competencies:
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)
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