#978 - Clinical Data Manager II

Job brief - Opportunity only available for Latam professionals. We are looking for a Clinical Data Manager II to support and independently manage data management activities for clinical development programs within the Data Management organization. The candidate will play a key role in delivering high-quality, compliant, and submission-ready clinical data , serving as a functional partner to cross-functional stakeholders and supporting regulatory inspection readiness. Responsibilities Independently manage data management activities for assigned clinical studies from study start-up through database lock. Develop, review, and maintain key data management deliverables, including: Data Management Plans (DMPs), eCRF specifications and completion guidelines, edit check and validation specifications, and data transfer specifications. Lead study database design, build, testing, and maintenance activities within EDC systems. Oversee routine data review, query management, trend analysis, and issue resolution. Coordinate and manage data reconciliation activities with internal teams and external vendors (e.g., labs, ECG, imaging). Support interim analyses, database locks, and final data delivery to Biostatistics and Statistical Programming. Ensure all data management deliverables are accurate, traceable, and inspection-ready in compliance with SOPs, ICH guidelines, CDISC standards, and FDA/EMA requirements. Collaborate cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Medical Writing, and Regulatory Affairs. Support preparation for audits and regulatory inspections and contribute to inspection responses related to data integrity and data handling. Manage and oversee external vendors or CRO data management activities as assigned. Identify data quality risks and proactively propose mitigation strategies. Contribute to the continuous improvement of data management standards, processes, templates, and tools Requirements Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or a related discipline; advanced degree preferred. 3 years of experience in clinical data management within a pharmaceutical, biotechnology, or clinical research organization. Strong understanding of clinical trial data management processes and the end-to-end clinical development lifecycle. Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault CDMS). Working knowledge of CDISC standards (SDTM) and their application in regulatory submissions. Familiarity with applicable regulatory guidance (e.g., ICH E6, ICH E9, FDA/EMA expectations). Experience supporting database locks and contributing to regulatory submissions (e.g., NDA, BLA, MAA). Strong organizational and time management skills with the ability to manage multiple studies or priorities. Excellent written and verbal communication skills. High attention to detail and strong documentation and compliance practices 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.