#992 - Clinical Data Manager III

Job brief - Opportunity only available for Latam professionals. We are looking for a Clinical Data Manager III to independently lead data management activities for complex clinical studies or multiple studies within a program. The Clinical Data Manager III will serve as a primary data management contact for cross-functional teams, support regulatory inspection readiness, and provide guidance to junior data management staff. Responsibilities Independently manage end-to-end data management activities for assigned clinical trials or program components. Lead the development, review, and approval of data management deliverables, including: Data Management Plans (DMPs) / eCRF specifications and completion guidelines/ Edit check and validation specifications / Data transfer and reconciliation specifications. Oversee study database design, build, testing, and maintenance within EDC systems. Monitor ongoing data quality, manage queries, and perform trend analysis to proactively resolve data issues. Coordinate and oversee external vendors, CROs, and internal teams for data collection, reconciliation, and validation activities Ensure timely database locks and delivery of data to Biostatistics and Statistical Programming for analysis Maintain compliance with internal SOPs, ICH guidelines, CDISC standards (SDTM), and FDA/EMA regulatory requirements. Prepare and maintain inspection-ready documentation, supporting audits and health authority inspections. Collaborate cross-functionally with Clinical Operations, Biostatistics, Programming, Medical Writing, and Regulatory Affairs. Identify risks to data quality or study timelines and implement mitigation strategies. Provide guidance, mentorship, and informal training to junior data management staff. Contribute to continuous improvement initiatives, including development of templates, tools, and standard processes. Requirements Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or a related discipline; advanced degree preferred. 4–5 years of clinical data management experience in the pharmaceutical, biotechnology, or CRO environment. Solid understanding of clinical trial processes and the end-to-end data management lifecycle. Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault CDMS) In-depth knowledge of CDISC standards (SDTM) and data submission requirements. Experience supporting database locks and regulatory submissions (e.g., NDA, BLA, MAA) Working knowledge of applicable regulatory guidance (e.g., ICH E6, ICH E9, FDA/EMA guidance) Proven ability to manage complex studies or multiple trials concurrently. Strong analytical, organizational, and time management skills. Excellent written and verbal communication skills, with ability to interact with cross-functional teams and external vendors. High attention to detail, quality, and documentation standards. What we do offer Salary in USD . 100% Remote work. Type of contract: Independent contractor with Venon Solutions LLC. Contract Duration: Long-term contract. Paid Holidays f rom the US Calendar. 2 weeks of Paid Time Off ( PTOs ). Working hours: EST, full-time, fully committed.