The Associate Director of Clinical Operations will have program-level accountability for clinical trials timelines, budgets, quality, and ensuring compliance with Good Clinical Practice (GCP) and may mentor and manage Clinical Trial Managers and other clinical operational staff in the execution of clinical trials.
This role works closely with Medical Monitors, cross-functional representatives, CROs, and other study vendors to ensure successful completion of all clinical study activities and project deliverables within the required time frame and budget.
Responsibilities - Partner with Clinical Operations leaders on strategy for successful implementation and execution of clinical trials
- Ensure trials are carried out according to the study protocol, SOPs, and ICH/GCP guidelines/regulations and study specific manuals and procedures
- Independently and strategically develop and manage the trial's timelines, study budget, key deliverables, and risk/mitigation strategies
- Ensure appropriate management and escalation of challenges regarding the trials' milestones, metrics, and critical path
- Manage clinical operational staff including hiring, performance development, training, and mentoring
- Lead or support the identification and management of CROs and other third-party study vendors
- Track and ensure optimization of site startup activities and activation, subject enrollment, data collection, and study closeout
- Develop site recruitment, enrollment, and engagement strategies
- Identify, select, and monitor performance of investigational sites; ensure accurate and timely site visit reports
- Manage and improve performance of third-party vendors and field CRAs to ensure compliance with study protocol and consistency with scope of work
- Manage the budgets and payments for CROs and investigative sites
- Lead the development and provide clinical operations expert input into of trial materials (e.g., protocol, informed consent forms, case report forms (CRF), CRF completion guidelines, monitoring guidelines, site initiation visit materials, site tools and worksheets, product administration guidelines)
- Develop and maintain good working relationships with investigators and study staff
- Ensure completeness and inspection readiness of Trial Master Files
- Oversee investigational product release packages and investigational product accountability
- Perform clinical data review of data listings and summary tables, including query generation
- Other duties as assigned
Qualifications - Bachelor's degree or equivalent in the life sciences
- At least 10 years of clinical operations experience in the pharmaceutical industry with significant knowledge of GCP/ICH guidelines and the clinical development process
- At least 3 years of experience managing industry sponsored pharmaceutical clinical trials as a sponsor employee (experience managing at least one global Phase 3 trial is highly preferred)
- At least 2 years of experience leading, managing, and mentoring clinical operational staff and cross-functional teams
- Ability to plan, organize and conduct clinical trials with minimum oversight
- Significant experience managing CROs and other vendors and assessing performance and finances (e.g., invoice review, change order management, and budget reforecasting)
- Strong interpersonal, communication (written and verbal), and prioritizing/organizational skills
- Demonstrated ability to work independently and as part of a multi-functional study team
- Able to motivate a team to work effectively
- Able to solve problems under pressure
- Self-motivated and able to work effectively in a matrix/team environment
- Must be willing to travel domestically and internationally (approximately 20-30%), as needed
