• Team Lead, EDC Programmer

    Cook Medical (West Lafayette, IN)


    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.

    Qualifications

    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.

     

    Requisition ID2025-16324

     

    Posting Date1 month ago(3/31/2025 9:04 AM)

     

    Job Location(s)West Lafayette IN United States

     

    Job LocationsUS-IN-West Lafayette

     

    Position TypeFull Time

     

    CompanyCook Research Inc.

     

    CategoryClinical