Associate Director, Clinical Operations

The Associate Director of Clinical Operations will service the Clinical Program Director for assigned Global Development Team(s) (GDT); overseeing clinical trial execution and operational strategy. This role will have line management responsibilities for Clinical Operations team members including but not limited to Clinical Project Managers and Sr. CRAs and will foster a collaborative and high-performing environment while maintaining oversight of CROs, study execution, ensuring data integrity, regulatory compliance and adherence to budget parameters and timelines . 

Job Responsibilities: 

• Clinical Program Management: lead the planning, execution, and monitoring of clinical trials, ensuring that trials are conducted in accordance with clinical development planning, regulatory guidelines, and Good Clinical Practice (GCP).

• Clinical Trial Oversight: Oversee the clinical trial life cycle, from study design to study completion. This includes strategy development, trial progress monitoring, and risk management. Provide guidance and support to clinical teams on trial execution, risk mitigation and problem-solving.  

• Risk Mitigation: Identify and address any operational risks, implementing corrective and preventative actions as necessary to keep trials on track.

• Vendor Management: Oversee the selection and maintain oversight of external vendors such as CROs and/or other service providers, ensuring adherence to timelines and quality standards. Manage assigned CRO relationships; serve as an escalation point for study teams (e.g. performance challenges, timeline delays etc) and drive resolution with CRO counterpart(s). Contribute to development of governance charters and participate in governance meetings.  

• Collaboration: Work closely with cross-functional teams, including Regulatory, Safety, and Clinical Development to ensure alignment on clinical development strategy and execution.

• Budget & Resource Management: Monitor budgets and resource allocation for clinical trials, ensuring that trials are conducted efficiently and within budget. Responsible for annual (and quarterly updates) for assigned Clinical Program(s).

• Clinical Trial Reporting: Support the preparation of clinical trial reports, regulatory submissions, and other documents required for clinical trial progress or regulatory review.

• Process Development and Continuous Improvement: Contribute to process development and improvement initiatives, ensuring that clinical operations remain efficient, scalable, and adaptable to the evolving needs of the organization. Will be assigned as process owner for sub-set of department processes.  
  Line Management: Will have line management responsibilities for Clinical Operations team members including but not limited to Clinical Project Managers and Sr. CRAs