#992 - Clinical Data Manager III

Opportunity only available for Latam professionals.

About the role

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.

Benefits

• Salary in USD.
• 100% Remote work.
• Paid Holidays from the US Calendar.
• 2 weeks of Paid Time Off (PTOs).

Schedule

• Working hours: EST, full-time, fully committed.

Pay

Type of contract: Independent contractor with Venon Solutions LLC.

Contract Duration: Long-term contract.