Associate Director, Data Operations - San Francisco, CA, United States - Torrey Pines Solutions

Description

• Recruit, manage, train and develop staff.
• Motivate and manage team members through setting of individual goals, providing on-going feedback, and performance evaluations.
• Delegate and provide general oversight of collaborations by providing program management level guidance to direct reports.
• Provide matrix support for staff in Clinical Operations on design initiatives to enable critical thinking, planning, prioritization, adherence to study needs and escalation as needed.
• Oversee staff expenditures.
• Manage resources according to department strategy.
• Review staff deliverables.
• Program Management, Cross-Functional Leadership & Collaboration:
• Strategically represent Clinical Operations on cross-FMI initiatives and governance committees (LCT).
• Oversee Sponsored research including protocol and consent development, IRB submissions and interactions with Regulatory Authorities.
• Initiate contracting discussion with legal and external collaborator and maintain a comprehensive knowledge of each executed agreement to ensure progress against deliverables.
• Meet with internal stakeholders on alignment and towards achievement of project goals, adequate resource availability for delivery on commitments.

• Establish strong partnership/relationship with internal and external stakeholders.
• Support partnership negotiations as opportunities for improvements arise.
• Ensure consistent execution of Clinical Operations strategy, processes and procedures:
• Contribute to design and development of Clinical Operations strategy.
• Identify and mitigate against study risks, partnering with the appropriate internal stakeholders to document any deviations, and analyze/build solutions as appropriate.
• Support regulatory authority and Sponsor audits and inspections.
• Escalate compliance issues/risks to Clinical Operations, Medical and biopharma leadership.
• Create and execute monthly, quarterly and annual financial, capacity and resource planning with department leadership team in close collaboration with Finance and HR Business Partners.
• Collaborate with internal Technology team in prioritization for development, testing and roll-out of new and updated systems and delegation of appropriate tasks to Principal and/or Senior CPL.
• Contribute to the development and execution of Clinical Operations goals and initiatives:
• Sponsor departmental or cross-functional projects and initiatives.
• Lead and/or sponsor internal initiatives to improve Clinical Operations processes and tools.
• Maintain knowledge of current GCP and CGP regulations and guidelines and company policies, SOPs and procedures.