Senior Clinical Data Manager

Role: Senior Clinical Data Manager responsible for end-to-end data management activities in clinical studies, from startup to closeout. Objectives include developing data cleaning strategies, leading data review efforts, and ensuring data quality and compliance. Core responsibilities encompass project management, authoring key documentation (e.g., Data Management Plans, review guidelines), overseeing data review and reconciliation, performing User Acceptance Testing (UAT) of EDC systems, managing user access, and facilitating cross-functional collaboration with Clinical, Programming, and Regulatory teams. Also involved in process improvement initiatives to update SOPs and work practices. Requirements: minimum 5 years of clinical data management experience within pharma or medtech, deep understanding of clinical trial processes, FDA/ICH guidelines, GCDMP, and CDISC standards. Hands-on experience with EDC systems (e.g., MedNet, Rave, Veeva), strong analytical, problem-solving, and communication skills, and a Bachelor’s degree in a scientific or technical discipline. Preferred qualifications include familiarity with Ophthalmology therapeutic area and experience with CRF and edit check creation. The role demands multiple task handling across phases of clinical development, emphasizing data quality assurance and cross-team collaboration.