Assistant Manager- (purchase) Strategic Sourcing

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