Manager – Clinical Research
Location: Felix Hospital, Greater Noida
Department: Clinical Research
Reporting To: COO / Medical Director
Job Summary
Felix Hospital is seeking an experienced Manager – Clinical Research to establish and lead the Clinical Research department. The incumbent will be responsible for managing clinical trials, ensuring regulatory compliance, coordinating with investigators, sponsors, CROs, Ethics Committees, and internal stakeholders while maintaining the highest standards of Good Clinical Practice (GCP) and regulatory requirements.
Key Responsibilities
- Build and manage the hospital's Clinical Research function.
- Develop relationships with sponsors, CROs, pharmaceutical, biotechnology, and academic partners to expand clinical trial opportunities.
- Conduct feasibility assessments, site readiness, trial start-up, and study activation.
- Manage trial documentation, SOPs, regulatory submissions, informed consent forms, approvals, and essential study files.
- Coordinate Ethics Committee submissions, NDCTR, CDSCO, and CTRI compliance.
- Oversee patient screening, recruitment, enrollment, follow-up, and protocol adherence.
- Monitor study milestones, deviations, adverse events, CAPA, and audit readiness.
- Prepare sponsor updates, dashboards, management reports, and trial progress reports.
- Coordinate with Pharmacy, Laboratory, Nursing, Finance, Legal, and Administration teams for seamless trial execution.
- Support sponsor monitoring visits, regulatory inspections, and audits.
Qualifications
- B.Pharm with M.Sc. in Clinical Research (MBA in Hospital Administration preferred).
- GCP Certification is mandatory.
- Additional certifications in NDCTR 2019, Human Subject Protection, Regulatory Affairs, Pharmacovigilance, or Clinical Trial Management will be an added advantage.
Experience
- 4–8 years of experience in Clinical Research, Clinical Operations, Site Management, or Regulatory Coordination.
- Experience in clinical trial start-up, ethics committee submissions, sponsor communication, and regulatory documentation.
- Strong knowledge of NDCTR, CDSCO, CTRI, ICH-GCP, and clinical research processes.
Skills
- Clinical Trial Management
- Regulatory Compliance
- Documentation & Audit Readiness
- Ethics Committee Coordination
- Sponsor & CRO Management
- Patient Recruitment
- Project Management
- Leadership & Team Coordination
- Excellent Communication & Stakeholder Management
Healthcare/Hospital experience is mandatory.
Apply Now:
Interested candidates can share their updated resume with Deepanshu (HR) at +91 96436 53928.
Work Location: In person
