Roles & Responsibilities
• Act as the primary point of contact for internal teams, sponsors, and external vendors
• Manage clinical data timelines, deliverables, and project milestones
• Ensure data integrity and quality across EDC and ePRO systems
• Perform clinical data review, ePRO review, query generation, resolution, and reconciliation
• Support database transfers, data exports, and migrations
• Prepare and maintain Data Management Plans (DMP), CRF specifications, and training documents
• Participate in Site Initiation Visits (SIVs) and conduct site trainings
• Support User Acceptance Testing (UAT) and product launches
• Ensure compliance with GCP, ICH, HIPAA, GDPR, FDA 21 CFR Part 11, and Annex 11
• Assist in internal and external audits and respond to compliance findings
• Explore and support innovative approaches for remote and decentralized clinical trials
Qualification
• Undergraduate degree from an accredited university
• Preferred background in Life Sciences, Pharmacy, Biotechnology, or Computer Science
Experience
• 0–10 years of experience in Clinical Data Management, Clinical Research, or CRO environment
• Exposure to clinical trials, observational studies, or registries preferred
Skills
• Hands-on knowledge of EDC, ePRO, and EHR systems
• Familiarity with data standards such as CDISC, SDTM, FHIR, and OMOP
• Knowledge of MedDRA and WHO Drug coding dictionaries
• Strong understanding of clinical trial data workflows
• Good project management and organizational skills
• Strong communication and problem-solving abilities
• Ability to work independently in a remote environment
Preferred Skills
• Experience in rare diseases, gene therapy, or long-term follow-up studies
• Experience working with central labs or specialty vendors
• Exposure to digital health tools or mobile applications
About the Organisation
A leading organization in clinical research and healthcare data solutions, focused on delivering high-quality, compliant, and innovative clinical data management services to support global clinical trials.
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