Demo

Team Lead, EDC Programmer

Cook Medical
Lafayette, IN Full Time
POSTED ON 4/1/2025
AVAILABLE BEFORE 4/30/2025
Overview

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.

Responsibilities

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

Qualifications

  • 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.

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