Associate Director, Clinical Operations

Role Overview

• Reporting to the Director of Clinical Operations, this individual contributes to the development and implementation of strategic direction of clinical trials, acts as study team lead for Clinical Operations and is responsible for delivery of all clinical trial operational activities, across one or more studies.
• Accountable for overall management of clinical trials, including providing strategic direction to the study team, to meet corporate goals and timelines
• Collaborate with the Clin Development to assess study progress, ensure proper study conduct and adherence to the protocol
• Central role maintaining relationships with other internal functions, strategic partners and CROs
• Oversee functional deliverables to support program objectives, identify risks to study timelines, propose mitigations, and implement solutions with team and management support
• Communicate program status, cost, and issues to senior management
• Monitor global regulatory intelligence for international industry practices for operational efficiency and compliance
• Responsible for the coordination of team meetings, as assigned, with both internal and external partners
• Serve as a clinical trial lead for one or more trials and responsible for implementation, planning, and execution of clinical trial activities
• Cultivate and maintain strong relationships with investigators, and trial site managers and other site staff, as applicable
• Participates in the selection of vendors and manages their activities.
• Organize investigator meetings, as needed
• Coordinate timely data review to identify trends and discrepancies
• Responsible for all aspects of site management from feasibility, selection, start-up, maintenance, and close out
• Select, assess, and approve sites for activation
• Contribute to study budget, including regular forecasting and internal reporting
• Review invoices against scope of work and work completed to date, and to identify and communicate variances
• Responsible for management of CRO and vendors to support clinical operations contracted for the assigned study/studies

Requirements

• BA/BS required in a scientific / medical field, or equivalent work experience
• 8
• 10 years of industry experience
• Demonstrated ability to successfully manage and support clinical trial deliverables from start-up through close-out, including all financial tracking and reporting activities.
• Understanding of clinical trial design, protocol development and review
• Extensive experience with cross-functional leadership and clinical teams, including data review, database lock and study reporting activities
• Vendor management experience required given many accomplishments will come from external resources
• Experience in oncology studies is preferred
• Experience in maintenance of a submission ready eTMF required
• Experience in Quality Assurance, SOP (Standard Operating Procedure), and study plan writing, CAPA (corrective and preventative action) preparation and closure
• Experience with investigator-initiated and industry-sponsored studies
• Strong knowledge of GCP (Good Clinical Practice) and working knowledge in ICH (International Conference on Harmonization) (International Conference on Harmonization) GCP (Good Clinical Practice) E6 R2 regulations
• Knowledge of GDPR (General Data Protection Regulation) and how to apply appropriate practices to clinical trials
• Leadership ability and further potential to build relationships in a matrix environment, ability to multi-task in a dynamic and fast paced environment
• Excellent interpersonal, written, and verbal skills required
• Working experience / knowledge of timeline management tools (e.g., Smartsheet)

Tech Stack

• Google Cloud Platform

Benefits

• annual bonus
• stock-based long-term incentives
• medical, dental, and vision benefits
• retirement
• wellness stipend
• flexible time off