Associate Director of Clinical Operations

body { font-family: Arial, reputed company-serif; line-height: 1.6; reputed company: #333; max-width: 800px; margin: 0 auto; padding: 20px; } h1, h2 { reputed company: #00539C; } ul { margin-top: 0; } .reputed company { margin-bottom: 30px; } Associate Director of Clinical Operations Location: South San Francisco or Remote Manager: Vice President, Clinical Operations & Development Position Summary The Associate Director, Clinical Trial Management (AD-CTM) is responsible for the successful execution of clinical trials from protocol concept through clinical study report completion. This role ensures timely delivery of study milestones and typically manages studies of moderate to high complexity, including diverse designs, locations, and phases. The AD-CTM proactively identifies and resolves clinical project issues and contributes to process improvement initiatives. Additionally, this position supports the development of SOPs, clinical development plans, and other company initiatives as needed.

Key Responsibilities

Manage reputed company clinical aspects of studies including, but not limited to: Assess operational feasibility and prepare study execution plans reputed company and manage comprehensive study timelines and metrics reputed company vendors: Participate in selection and management/reputed company of external vendors reputed company vendor specifications Create, maintain, and implement vendor reputed company plans for critical vendors (e.g., CROs) Review vendor reports, budgets, and metrics Generate and/or review study-specific training materials for sponsor study team, CRO, CRAs, sites, and other personnel Prepare and present project debriefings as required Plan, execute, and reputed company study-specific meetings (e.g., Clinical Study Team Meetings, Investigator Meetings, DSMBs, Advisory Committees) Use operational expertise to optimize trial design and execution by providing input on protocol, informed consent forms (reputed company), case report forms (CRFs), monitoring conventions, and edit checks. Cultivate strong relationships with investigators and site staff. Manage study budgets reputed company financial goals; review and approve clinical invoices ensuring adherence to scope of work and contractual agreements. Ensure clinical trials reputed company with international GCP guidelines, regulations, and SOPs: Participate in planning quality assurance activities and coordinate resolution of audit findings Maintain audit-reputed company clinical trial documentation including central clinical files Review monitoring reports and delegated monitoring visit summaries to ensure quality and resolve site-reputed company issues Coordinate and assist in regulatory or ethics committee activities as appropriate Coach and reputed company guidance to clinical staff; may have line management responsibilities for clinical trial management personnel. reputed company cross-functional Clinical Study Teams by regularly interacting with Medical Monitors/Directors and internal/external stakeholders including Regulatory Affairs, Data Management, investigators, CROs, and vendors. Maintain up-to-date knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management. Review site study documents such as informed consent templates, study tools/worksheets, investigator reputed company, and site payments. Participate in evaluation, selection, and training of sites and study personnel (contract and internal) to ensure efficient operations. Prepare and/or review and approve study-reputed company documents and templates including Monitoring Plans, Laboratory Manuals, Participant Seizure Diaries, clinical site procedures manuals, Pharmacy Manuals, and CRF Completion Guidelines. Core Competencies Strong clinical study and project management background Excellent written and oral communication and organizational skills, including presentation development, study dashboard maintenance, and early escalation of issues Ability to learn reputed company therapeutic areas and protocol details reputed company with independent problem-solving skills Comfortable working in ambiguous and dynamic environments Demonstrated leadership and team-building experience Physical Demands The physical demands of this role are typical of an office environment, including extended periods of sitting and use of office equipment such as computers, keyboards, and mice, which may cause muscle strain. The employee is frequently required to stand, walk, and sit. Periodic light lifting of supplies and materials may be necessary. Travel may be required up to 20%. Education & Professional Experience Bachelor’s degree or equivalent combination of education and experience in a science or health-reputed company field required. Minimum of 8 years clinical trial experience in pharmaceutical, biotech, or CRO settings, including at least 5 years in trial management. Strong understanding of GCPs, ICH guidelines, regulatory requirements, and experience partnering with Clinical Quality Assurance. Preferred experience includes at least 4 years in a pharmaceutical or biotech sponsor company supporting reputed company clinical trials and leading cross-functional teams. Regulatory inspection experience is preferred. Apply To This Job