Senior Clinical Data Specialist (Remote – Costa Rica)

About the role

We are seeking a Senior Clinical Data Specialist to join our Clinical Data Management team. Based in Costa Rica and working remotely, you will act as the subject‑matter expert for local laboratory data, ensuring accurate, timely, and compliant delivery of lab results across a global portfolio of clinical studies.

Key responsibilities

• Lead and oversee local lab data activities for both in‑house and outsourced studies.
• Partner with CROs, vendors, and clinical sites to guarantee high‑quality lab data collection, transfer, reconciliation, and query resolution.
• Support study startup, maintenance, and database lock activities related to local labs.
• Maintain local lab analytes, LNR entries, and data standards.
• Represent local lab data management in project team meetings as the expert.
• Identify and implement process improvements, automation, and data‑quality enhancements.
• Ensure compliance with ICH‑GCP, FDA regulations, and internal standards.

Required profile

• Bachelor’s degree in health sciences, life sciences, technology, or related field, or equivalent experience.
• Minimum 3 years of experience in Clinical Data Management or drug development.
• Strong knowledge of local laboratory data management best practices and technologies.
• Proven experience working with CROs and external vendors.
• Solid understanding of clinical trial documents and processes.
• Ability to manage multiple studies and priorities simultaneously.
• Must be currently based in Costa Rica.

Required skills

• Laboratory data management systems
• CRO and vendor coordination
• ICH‑GCP compliance
• FDA regulatory knowledge
• Experience with NDA/CTD submissions (preferred)

What we offer

• Collaborative global environment with high scientific standards.
• Opportunities for career growth in clinical data management and drug development.
• Culture that values innovation, quality, and continuous improvement.