Advertisement
Are you passionate about clinical data management jobs in India and eager to make an impact in the healthcare research industry? A leading organization is hiring Associate / Senior Associate, Clinical Data Management (Remote – India). This role involves managing clinical trial data, electronic data capture (EDC), and patient-reported outcomes (ePRO) to ensure data integrity and compliance with global standards. If you have experience in clinical research, data management, and regulatory compliance, this could be your perfect career move.
📝 Job Responsibilities
As an Associate / Senior Associate, Clinical Data Management, your key duties will include:
- Acting as the point of contact for internal and external stakeholders.
- Managing data timelines, deliverables, and project milestones.
- Ensuring data integrity across EDC and ePRO systems.
- Performing clinical and ePRO data reviews, query management, and reconciliation.
- Supporting database transfers, exports, and migrations.
- Preparing documentation such as Data Management Plans, CRF specifications, and training materials.
- Participating in Site Initiation Visits (SIVs) and site trainings.
- Supporting user acceptance testing (UAT) and product launches.
- Ensuring compliance with GCP, ICH, HIPAA, GDPR, FDA 21 CFR Part 11, and Annex 11.
- Assisting in audits and responding to compliance checks.
- Exploring innovative approaches for remote clinical trial monitoring.
🎓 Qualifications & Skills
Education
- Undergraduate degree from an accredited university (Life Sciences, Pharma, Computer Science preferred).
Experience
- 0–10 years of professional experience in clinical research, data management, or CRO roles.
- Exposure to observational research, registries, and clinical trial protocols.
- Familiarity with EDC, ePRO, EHR systems, and data standards (CDISC, SDTM, FHIR, OMOP).
- Knowledge of MedDRA and WHO Drug coding dictionaries.
- Strong project management, communication, and problem-solving skills.
Preferred
- Experience in rare diseases, gene therapy, or long-term follow-up studies.
- Previous work with central or specialty labs/vendors.
- Digital or mobile app exposure.
🌟 Benefits of Joining
- 100% Remote – work from anywhere in India.
- Exposure to innovative digital health research tools like iTakeControl.
- Opportunity to collaborate with biotech clients and global CRO teams.
- Career growth in clinical data management and regulatory operations.
- Training and development in advanced healthcare technologies.
Advertisement
Advertisement
