Team Lead, EDC Programmer at Cook Research Inc. in West Lafayette, Indiana

Job Description:

Team Lead, EDC Programmer

Requisition ID 2025-16324

Posting Date 2 hours ago (3/31/2025 4:04 PM)

Job Location(s) West Lafayette IN United States

Job Locations US-IN-West Lafayette

Position Type Full Time

Company Cook Research Inc.

Category Clinical

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.

• 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.

• 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.

• 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.

• 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.

• 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.

• Knowledge of SQL or other programming languages used in data management.


• Familiarity with CDISC/CDASH standards.

• 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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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.