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 all clinical aspects of studies including, but not limited to:
  • Assess operational feasibility and prepare study execution plans
  • Develop and manage comprehensive study timelines and metrics
  • Oversee vendors:
    • Participate in selection and management/oversight of external vendors
    • Develop vendor specifications
    • Create, maintain, and implement vendor oversight 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 lead 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 (ICF), case report forms (CRFs), monitoring conventions, and edit checks.
• Cultivate strong relationships with investigators and site staff.
• Manage study budgets within financial goals; review and approve clinical invoices ensuring adherence to scope of work and contractual agreements.
• Ensure clinical trials comply with international GCP guidelines, regulations, and SOPs:
  • Participate in planning quality assurance activities and coordinate resolution of audit findings
  • Maintain audit-ready clinical trial documentation including central clinical files
  • Review monitoring reports and delegated monitoring visit summaries to ensure quality and resolve site-related issues
  • Coordinate and assist in regulatory or ethics committee activities as appropriate
• Coach and provide guidance to clinical staff; may have line management responsibilities for clinical trial management personnel.
• Lead 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 contracts, 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-related 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 complex therapeutic areas and protocol details
• Resourceful 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-related 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 complex clinical trials and leading cross-functional teams.
• Regulatory inspection experience is preferred.