REQ 294 AD, Clinical Operations

About the role

The Associate Director, Clinical Trial Operations plays a crucial role in ensuring high-quality clinical trial data is delivered efficiently, cost-effectively, and aligned with corporate objectives. This role oversees the execution of clinical trial protocols, manages external vendors, and collaborates with cross-functional teams.

Responsibilities

• Manage/oversee the conduct and execution of an assigned clinical trial and associated activities in accordance with Good Clinical Practices (GCP) and relevant national and international requirements.
• Identify, review, and select appropriate investigational sites and vendors.
• Manage and oversee CROs and selected study vendors, ensuring they meet predetermined program milestones according to budget and timeline.
• Work closely with study team to prepare and maintain manuals, forms, plans, and documents, and participate in internal cross-functional study team meetings.
• Contribute to the writing and review of clinical documents such as protocols, informed consents, investigator brochures, and clinical study reports.
• Ensure compliance with GCP and global regulatory guidelines.
• Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial.
• Recommend and implement innovative processes to improve and impact clinical trial management and deliverables including contingency plans.
• Ensure clinical studies are executed within projected budget, on time, and with highest quality.
• Support the development and management of clinical site budgets and vendor contracts, including review of invoices for accuracy.
• Work with Data Sciences to create and implement study-specific tools to ensure clean data and timely data entry.
• Write and/or review clinical operations SOPs and related quality documents including, but not limited to, training, tools, templates, CRO manuals, and vendor oversight plans.

Requirements

• Direct, prior experience with selecting and managing global CROs and other key vendors.
• Prior experience (either in leadership or as a regional lead) in global Phase 3 studies is required.
• Prior experience in managing, retaining, and developing clinical operations personnel is preferred.
• Current knowledge and understanding of FDA and ICH Guidelines, including Good Clinical Practices (GCP) E6(R2) requirements.
• Able to interact and influence effectively with multi-functional teams at all levels of the organization within Development.
• Proficient with word processing, spreadsheet and database software, clinical and financial systems.
• Familiarity with drug development processes across all phases of development (early to late stage).
• Travel will be required for clinical investigative site visits, vendor visits, meetings, and presentations.