Clinical Operations Specialist

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 Good 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.