Key Responsibilities
A. Clinical Strategy and Planning
· Develop clinical evaluation strategies for new and existing medical devices.
· Prepare Clinical Evaluation Plan (CEP), Clinical Investigation Plan (CIP), Study Protocols, CRFs, Informed Consent Forms, etc.
· Identify clinical evidence requirements based on device classification and regulatory pathway.
B. Clinical Investigations (Pre- and Post-Market)
· Lead end-to-end execution of clinical studies including feasibility, pilot, pivotal, PMS, PMCF, registry studies.
· Site identification, feasibility assessment, investigator selection and qualification.
· Able to perform initial CA and EC submissions, amendment, notification, progress and safety report submissions, contract negotiations without direct supervision.
· Ensure compliance with ISO 14155:2020, ICH-GCP, and NDCT-2019 guidelines.
· Collaborate with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocol and study outlines and subsequently driving identified initiatives.
C. Clinical Operations and Oversight
· Lead clinical Budgeting and Financial management, including preparation and negotiation of trial budgets, oversight of vendor contracts and clinical study agreements, management of investigator and site payments.
· Draft clinical study agreements, insurance documents, and ensure operational compliance across trial activities.
· Initiate, monitor and closeout clinical studies in accordance with MDCG, ICH-GCP guidelines and NDCT-2019 and Biotek SOPs.
D. Regulatory Support
· Support preparation of technical documentation for regulatory submissions (CDSCO, US FDA, EU MDR).
· Prepare CER (Clinical Evaluation Report), PMCF plans/reports, summary of safety & clinical performance (SSCP).
· Provide clinical evidence for 510(k), PMA, CE Marking, and Indian regulatory filings
E. Data Management & Reporting
· Oversee data collection, monitoring, and verification across study sites.
· Perform risk-benefit analysis and clinical literature review.
· Prepare interim and final clinical study reports (CSR) and statistical summaries.
F. Investigator & Site Management
· Train investigators, coordinators, and site staff on study protocol and GCP.
· Conduct site initiation, monitoring, and close-out visits.
· Manage adverse event reporting, safety documentation, and vigilance activities.
G. Cross-Functional Collaboration
· Provide clinical inputs during product design & development (as per ISO 13485 and risk management per ISO 14971) and Support KOL engagement and scientific communication.
H. Post-Market Clinical Follow-up (PMCF)
· Conduct surveys, registries, complaint analysis, and real-world evidence studies.
· Maintain robust Post-Market Surveillance (PMS) system.
I. Documentation and Compliance
· Prepare and Maintain TMF and Clinical documents per QMS, ISO 13485, ISO14971, ICH, GCP
Skills & Competencies
Technical Skills
· Strong knowledge of ISO 14155, ICH-GCP, ISO 13485, ISO 14971.
· Experience in study design, biostatistics, and clinical data interpretation.
· Hands-on experience with Clinical Evaluation Reports and PMCF documentation.
· Understanding of medical device regulations (CDSCO, FDA, EU MDR).
·Qualification & Experience
· Education:
o Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, or related field.
o Ph.D in clinical research or Additional certification in Clinical Research is a plus.
· Experience:
o 10+ years in Clinical Research, specifically in medical devices.
o Experience in conducting clinical investigations as per ISO 14155, ICH is mandatory.
o Experience in Orthopedics, Implants, Surgical Devices, Diagnostics, or similar device categories preferre
Contact person
Ansuya Satish/ Mahek Hindocha
98243 50317 / 98984 08648
[email protected]