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 Date2 weeks 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