Position Summary

The Manager - Clinical Research is responsible for planning, designing, executing, and managing clinical investigations for medical devices in accordance with regulatory requirements (CDSCO, EU MDR 2017/245, ISO 14155, ICH-GCP, NDCT-2019, and others), global clinical standards, and internal quality systems. The role ensures generation of robust clinical evidence to support product safety, performance, regulatory approvals, and post-market surveillance.

Key Responsibilities

A. Clinical Straegy 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 preperation 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

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).

Behavioural Skills:

- Excellent communication and scientific writing.

- Strong project-management and leadership capabilities.

- Vendor & stakeholder management.

- Detail-oriented, analytical thinker.

- Ability to handle audits and regulatory inspections confidently.

Qualification & Experience:

Education:

- Master's degree in Life Sciences, Biomedical Engineering, Pharmacy, Biotechnology, or related field.

- Ph.D in clinical research or Additional certification in Clinical Research is a plus.

Experience:

- 10+ years in Clinical Research, specifically in medical devices.

- Experience in conducting clinical investigations as per ISO 14155, ICH is mandatory.

- Experience in Orthopaedics, Implants, Surgical Devices, Diagnostics, or similar device categories preferred.

Additional Requirements

- Willingness to travel for site monitoring.

- Ability to manage multiple studies simultaneously.

- Strong ethical orientation and patient-safety focus.