Team Lead, EDC Programmer

The Team Lead, EDC Programmer is responsible for leading a team of EDC Programmers while actively participating in the design, development, testing, and maintenance of Electronic Data Capture (EDC) systems to support clinical trials. This role ensures high-quality, regulatory-compliant clinical data collection systems and contributes to the overall success of clinical research initiatives. Responsibilities include (but are not limited to): setting priorities, allocating resources, driving process improvements, and training personnel to facilitate the EDC Programmer needs of global clinical projects.

Primary Purpose:

• Lead and manage a team of EDC Programmers to achieve global business needs.
• Develop databases for clinical studies using approved EDC software systems.
• Ensure compliance with departmental standards and study protocols.

Team Leadership and Management:

• Provide leadership in accordance with company policies, procedures, and applicable laws and regulations.
• Encourage and foster employee development through mentorship and training.
• Set priorities, allocate resources, and drive process improvements.
• Conduct team meetings, one-on-one meetings, and maintain ongoing communication with team members.
• Foster an environment where the giving and receiving of feedback is encouraged.
• Provide input on recruitment, performance reviews, and disciplinary actions.
• Orient, train, and/or mentor new members to the team, as needed.

Database Design and Development:

• Design, build, test, and maintain clinical databases, including forms, edit checks, CRF standard libraries, EDC modules, and standard system reports.
• Lead team reviews and User Acceptance Testing to validate database specifications.
• Ensure data quality through edit checks, form logic, and data validation.
• Manage user and site administration, including setting up roles, permissions, and training requirements.

Quality Control and Compliance:

• Verify completeness of study deliverables and maintain all required study documentation.
• Ensure compliance with Good Clinical Practice (GCP), 21 CFR Part 11, and other relevant regulations.

Database Support:

• Provide expertise for problem-solving with clinical database technology, capabilities, and functionality.
• Support development and review of Standard Operating Procedures (SOPs) and work guidelines to promote consistency.
• Identify additional opportunities for standardization and departmental efficiency.
• Troubleshoot and resolve EDC-related issues, including escalation of study-specific functional issues, tool/vendor issues, testing and validation needs, enhancement requirements, and custom functions.

Collaboration:

• Work closely with clinical stakeholders to align on project needs and ensure data integrity.
• Provide technical assistance and training to technical and non-technical personnel.

Required:

• Bachelor’s degree in Computer Science, Life Sciences, or a related field or comparable work experience.
• Minimum 7 years experience in a clinical data management or EDC programming role, with at least 2 years in a leadership or mentorship role
• Prior experience in the conduct of clinical studies, preferably in the medical device industry.
• Prior EDC configuration experience with platforms such as Zelta, Veeva Vault EDC, Medidata Rave, or similar software.
• Experience with custom functions, integrations, or scripting within EDC platforms
• Working knowledge of FDA and other regulatory requirements that may impact global clinical projects.

Preferred:

• Knowledge of SQL or other programming languages used in data management.
• Familiarity with CDISC/CDASH standards.

Competencies & Soft Skills:

• Strong problem-solving skills, logical thinking, and attention to detail.
• Effective communication and collaboration abilities.
• Excellent organizational, leadership, and problem-solving skills.
• Ability to manage multiple projects in a regulated environment.
• Ability and desire to work in a collegial team atmosphere, including communicating and working constructively with colleagues.