Summary:
The Director, Clinical Data Management (CDM) is responsible for leading and executing the organization’s CDM strategy in alignment with overall company objectives. This role provides oversight of assigned operational areas, including financial performance, across multiple delivery models such as Functional Service Provider (FSP), Full-Service, and stand-alone CDM engagements for designated sponsors.
The Director ensures the consistent delivery of high-quality services, driving customer satisfaction and operational excellence. This position provides leadership and guidance to the CDM team while ensuring compliance with all applicable Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) ICH Guidelines, regulatory requirements, and sponsor-specific standards.
Serving as a primary liaison between clients and internal stakeholders, the Director leverages deep expertise in clinical data management, operations, and financial oversight to understand business needs, inform decision-making, and support efficient day-to-day execution.
Essential Duties and Responsibilities include the following. Other duties may be assigned at the company’s sole discretion.
- Lead the execution of CDM and broader company strategies, ensuring alignment with organizational goals.
- Provide oversight of CDM delivery across assigned regions and service models (FSP, Full-Service, Stand-Alone).
- Manage assigned sponsor financials and/or department, as requested
- Create, oversee, and participate in department and company initiatives.
- Responsible for selection, training, development and performance management of reporting staff
- Resourcing of staff and/or projects (direct staff or vendor/supplier)
- Ensure team deliverable are completed on time and with high quality
- Ensure metric goals for assigned sponsor(s) are met or exceeded, proactively managing and mitigating risks
- Influence cross-functional leadership participation to ensure sponsor and/or project goals are effectively supported
- Support business development activities such as contracts, proposals, bid defense meetings, conferences and work to obtain new business, as requested
- Participate in and/or contribute to sponsor and/or regulatory audits/inspections
- Review, update and/or create SOPs as needed.
- Manage statements of work, vendor contracts, and partner accountability.
- Ensure proper testing, documentation, and process monitoring.
- May be a core member of governance meetings, participating and/or attending, as required.
- Ability to travel up to 30% as needed.
- Perform other duties as required.
Qualifications & Educational Requirements:
- Bachelor’s degree in life sciences, pharmacy, or related field preferred.
- Minimum of 7 years of functional clinical data management (CDM) work experience and 6+ years of management experience preferred.
- A combination of 5+ years of functional CDM experience and 5+years of management experience may also be considered.
- Broad knowledge of drug development processes, metabolic experience preferred
- Understanding of global clinical development budgets and relationship to productivity targets
- Knowledge of effective clinical data management practices
- Vendor management experience (preferred)
- Ability to quickly analyze and resolve technical issues
- Strong analytical, problem solving, project management, and stakeholder management skills
Skills, Knowledge, and Abilities:
- Experience working with Electronic Data Capture (EDC) systems and vendor platforms, including knowledge of URL testing requirements.
- Experience working with global and cross-functional teams.
- Strong project management skills.
- Proven leadership and management experience.
- Experience with resource planning and team staffing.
- Commercial experience supporting proposals, bidding, or bid defense.
- Experience supporting sponsor governance meetings and relationship kick-off meetings.
- Strong written and verbal communication skills.
- High attention to detail and strong organizational skills.
- Strong computer skills, including proficiency with Microsoft Office and data management systems.
- Ability to prioritize work and manage multiple projects simultaneously.
- Able to make decisions effectively in dynamic or evolving environments.
- Flexible, collaborative team player.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stoop, kneel, crouch, or crawl.
