Sr Clinical Data Specialist
Clinical Data Management
📍 Location: Colombia (Colombia–based candidates only)
We are shaping the future of medicine through science, data, and collaboration. We are looking for a Sr Clinical Data Specialist based in Colombia to join our Clinical Data Management (CDM) team and play a key role in delivering high‑quality clinical trial data across a global portfolio.
About the role
In this role, you will be the subject‑matter expert for local laboratory data, ensuring accurate, timely, and compliant lab data delivery across clinical studies. You’ll work closely with internal teams, CROs, and vendors, contributing to study success from startup through database lock.
This is an excellent opportunity for a data management professional located in Costa Rica who enjoys cross‑functional collaboration, vendor oversight, and continuous process improvement.
What you’ll do
- Lead and oversee local lab data activities for in‑house and outsourced clinical studies
- Partner with CROs, vendors, and clinical sites to ensure high‑quality lab data collection, transfer, reconciliation, and query resolution
- Support study startup, maintenance, and database lock activities related to local labs
- Maintain and manage local lab analytes, LNR entries, and lab data standards
- Represent Local Labs Data Management in project team meetings as a subject matter expert
- Collaborate with Clinical Operations, Biometrics, Medical, and Regulatory teams
- Identify opportunities to improve processes, automation, and data quality
- Ensure compliance with ICH‑GCP, FDA regulations, and internal standards
What you bring
- Bachelor’s degree (health sciences, life sciences, technology, or related field) or equivalent experience
- 3+ years of experience in Clinical Data Management or drug development
- Strong knowledge of local lab data management best practices and technologies
- Experience working with CROs and external vendors
- Solid understanding of clinical trial documents and processes
- Ability to manage multiple studies and priorities simultaneously
- Strong communication, collaboration, and problem‑solving skills
- Experience with NDA/CTD submissions is a plus
- ✅ Must be currently based in Colombia
Why join
- Work in a collaborative, global environment with high scientific standards
- Opportunity to grow your career in Clinical Data Management and drug development
- A culture that values innovation, quality, and continuous improvement
Learn more about our EEO & Accommodations request here.
Originally posted on Himalayas