Clinical Database Programmer(CF)
The Clinical Database Programmer (CF) at eClinical Solutions is responsible for providing technical support and oversight for the implementation of the Medidata Clinical Cloud (MCC). This role involves maintaining a project-level perspective and effectively communicating as the MCC subject matter expert on technical and functional electronic data capture programming and data management activities, timelines, and deliverables.
Key responsibilities include designing, developing, and testing clinical databases, which encompasses creating forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions, and standard and custom reports. The programmer will perform peer reviews for studies built by other Clinical Database Programmers and ensure the development, maintenance, and compliance of database builds and EDC standards in support of clinical studies. Additionally, the role involves managing timely and quality deliverables for assigned protocols or studies and functioning as an EDC Subject Matter Expert by providing guidance and best practice recommendations to data management and operations teams.
The ideal candidate should possess a bachelor's degree or equivalent work experience, with at least 2 years in the pharmaceutical or biotechnology industry. Experience with requirements gathering, design and specification development of case report forms (CRFs), edit checks, site queries, and a solid understanding of database structures and programming languages are essential. Proficiency in Microsoft Office applications, specifically MS Project and MS Excel, is required. Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology is preferred. Technical skills should include proficiency in C# programming language, expert knowledge of Medidata Clinical Cloud (MCC), especially Rave EDC capabilities and best practices, and familiarity with clinical systems and technologies such as ePRO, IVRS/IWRS, and CTMS.
eClinical Solutions offers a dynamic work environment that fosters professional growth and development. Employees have the opportunity to work on innovative projects that contribute to accelerating clinical research and bringing life-changing therapies to patients faster. The company values diversity and inclusion, providing a supportive culture where team members can thrive and make a meaningful impact in the healthcare industry.