Clinical Research Manager

Company : Manufacturer, exporter, distributor, and supplier of orthopedic and arthroscopic medical devices . Their products include a wide range of orthopedic implants, surgical instruments, arthroscopy equipment, reconstruction nails, and joint replacement components.

Position : Manager - Clinical Research

Job 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 Planing

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

Desired Profile :

Education:

• B.E. - Biomedical Engineering /B.Pharm / M.Pharm or related field.
• 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 Orthopaedics, Implants, Surgical Devices, Diagnostics, or similar device

Contact

RIna Arun