#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 from the US Calendar.
• 2 weeks of Paid Time Off (PTOs).
• Working hours: EST full-time, fully committed.