Job Description

About EMA Wellness EMA Wellness is a market leader providing clinical data capture, analytics, and adjudication solutions to pharma companies and CROs undertaking clinical trials. Founded in 2018, the company has experienced exponential growth since 2024. The Opportunity This is an exceptional opportunity to join a healthcare technology company fast emerging as the market leader in CNS clinical trials. Reporting to the EVP of Operations, the Clinical Data Manager (CDM) will work directly with the DPO, head of product, CTO, and CEO to evolve and in some cases drive data strategy and implementation. The CDM will be responsible for the overall data management of clinical trials, ensuring the accuracy, completeness, and compliance of clinical trial data with study protocols, company SOPs, and regulatory guidelines. This role involves defining data specifications, managing and implementing all data transfers to CROs and sponsors, and managing quality control of data collection in worldwide clinical research programs. Duties and Responsibilities Provide ownership of the data management lifecycle, from data collection to database lock. Develop and implement data validation checks (edit checks) and procedures. Collaborate in study start-up activities, including the Data Management Plan and Data Transfer Specifications. Serve as the primary data management contact for internal and external stakeholders. Ensure compliance with study protocols, ICH‑GCP, regulatory requirements, and CDISC/SDTM standards. Maintain thorough documentation of all data management processes and decisions, ensuring audit readiness. Implement quality control procedures throughout the data management process. Provide clean, scalable data sets for advanced clinical analytics. Drive and implement AI tools to create more scalable data transfers and higher data quality. Success Metrics Mitigation of EDC, CRO and sponsor queries. Successful DTS transfer to CRO and/or sponsor according to timelines and quality expectations. Adherence to SOPs and limited data quality findings in sponsor and CRO audits. Effective management across platform, product, clinical, and delivery business units. Requirements and Expectations Experience with clinical trial data at a CRO, vendor (eCOA or EDC), or sponsor. Experience with eCOA and clinical trial source data. Experience supporting clinical trial data analytics. Experience in CNS clinical trials. Bachelor’s degree with proven experience as a Clinical Data Manager or in a relevant data management role. Familiarity with data standards (e.g., CDISC, SDTM, CDASH) is preferred, as is knowledge of GCP and 21 CFR part 11 requirements. Good communication skills, with the ability to work across multiple teams. Ability to manage multiple projects in a fast‑growing company without compromising required processes and quality control. Seniority Level Mid‑Senior level Employment Type Full‑time Job Function Research, Analyst, and Information Technology Industries: IT Services and IT Consulting #J-18808-Ljbffr EMA Wellness

Job Tags

Similar Jobs