Job description

Role Summary

A Clinical Operations Associate (COA) Shall play a vital role in supporting the in-house daily operations, and clinical documentation of products including for the Clinical Investigations as per the ISO 14155:2020 Appendix E and IMDRF STED Module V. The COA will ensure that all documents are accurate, organized, and compliant with ISO 14155:2020 Appendix E, EU MDR 2017, India Medical Device Rules 2017, Schedule 7 and 8, and Standard Operating Procedures (SOPs).

Key Result Areas

- Product Clinical Module Management as per IMDRF STED Module V

- Creation of product clinical file and make an audit-readiness check every 3 months. Publish the document list every alternate week.

- Ensure periodical updates of the Clinical Risk Management File and its synchronization with the product Risk Management file when either of these are updated

- Ensure availability of all accurate, organized, and complete documents in the Product Clinical Module File, as per IMDRF STED module V, ensuring all the documents are complaint for submissions

- Clinical Investigation Documentation & File Management:

- Create a folder structure with appropriate sharing rights for Essential Clinical Investigation Documentation Files (ECIDF) as per Annex E of ISO 14155:2020 and India MDR 2017, Schedule 7, and Investigator Site Files (ISF) as per Veeva IDF model 2020.

- Maintain the ECIDF and ISF and ensure audit readiness at all points in time. Publish a weekly report for document checks.

- Ensure all essential study documents are collected, reviewed, and properly archived, as per the Valuable Documentation Practice guidelines and meet requirements of ISO 13485 QMS.

- Support the creation and maintenance of study metrics trackers, reports, and dashboards.

- Invoicing and payments management for clinical investigations with respect to the clinical sites.





- Study Startup & Execution:

- Assist in the preparation, tracking, and submission of regulatory documents (e.g., informed consent forms).

- Coordinate with vendors for clinical supplies, such as laboratory kits or investigational products.

- Assist with the coordination of investigator meetings and site initiation visits (SIV).

- Site Liaison & Support:

- Act as a point of contact for clinical sites for administrative requests, such as missing documentation or enrollment updates.

- Assist with the tracking of site-specific payments.

- Compliance & Quality Control:

- Review study documents and data for accuracy and completeness.

- Assist with audit preparation and ensure compliance with ICH-GCP guidelines.

Required Skills & Qualifications

- Education: A bachelor’s degree in medicine, pharmacy, nursing or biomedical Engineering or Master’s degree in a relevant life sciences field such as biology, toxicology, biotechnology or statistics

- Experience: Previous experience minimum 1 year as a CTA, Study Coordinator, or similar role within Medical Device Company or a CRO, with understanding of ISO 14155:2020.

- Knowledge: Strong understanding of ISO 14155:2020, India MDR Schedule 7, DIA 3.x TMF model, ISO 14155:2020 ECIDF model, IMDRF STED methodology etc.

- Technical Skills: Proficiency in Microsoft Office Suite (OneDrive, Sharepoint, Excel and Word)

- Soft Skills:

- Attention to Detail: High level of accuracy in document review.

- Communication: Excellent interpersonal skills for interacting with internal and external stakeholders.

- Organizational Skills: Ability to manage multiple tasks, prioritize, and meet tight deadlines.

Job Snapshot

Updated Date

26-08-2026

Job ID

JOB11019

Division

MedTech Office

Location

Zydus Medtech Private Limited|ZMPL Office, Ahmedabad, Gujarat, India

Employee Type

P-P8-Probationer-HO Executive

📌 Clinical Operations Associate (India)
🏢 Zydus Group
📍 India