Study Manager, Global Study Operations

Intelliswift Software • San Rafael, CA

278d

About The Position

The Study Manager, Global Study Operations is responsible for the overall execution oversight of clinical studies. This role can be performed in-house at the San Rafael location, or in a hybrid or fully remote capacity. The position requires leadership and guidance to the Global Study Operations (GSO) staff assigned to various studies, ensuring that all study deliverables, documents, and plans are executed effectively. The Study Manager will lead cross-functional Study Execution Team (SET) meetings and collaborate with team members to proactively identify and manage study issues, risks, and mitigations. Regular updates on study quality and progress will be provided to key stakeholders, and the manager will monitor study metrics to ensure timely follow-up and action where necessary. Additionally, the role involves contributing to the development of study protocols and informed consent forms, managing study timelines, budgets, and lifecycle processes, and overseeing feasibility, recruitment, and enrollment efforts.

Requirements

• Proficiency in decision making and problem solving
• Strong influence and organizational awareness
• Agility and proactivity in managing studies
• Demonstrated leadership skills
• Excellent communication and collaboration abilities
• Experience in data analysis and interpretation
• Knowledge of study management and execution
• Understanding of compliance and quality standards
• Familiarity with drug development and study design
• Knowledge of managing all phases of clinical trials (Early Clinical Development/Ph 1 through Post Approval studies)

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
• 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

What This Job Offers

• Job Type: Full-time
• Industry: Professional, Scientific, and Technical Services