Clinical Operations Associate - Medical Device Clinical Research

Why This Role Matters

Clinical operations professionals play a crucial role in ensuring that clinical investigations for medical devices are conducted efficiently, ethically, and in compliance with regulatory requirements. They help maintain accurate documentation, coordinate study activities, and support the successful execution of clinical trials. The Clinical Operations Associate – Medical Device Research role focuses on supporting clinical investigation documentation and operational processes. This ensures that clinical studies follow regulatory standards and that all study-related records are properly organized and audit-ready. Another key aspect of the role is maintaining clinical documentation according to global standards. Proper document management is essential for regulatory submissions, safety monitoring, and maintaining the credibility of clinical research. In addition, clinical operations associates collaborate with investigators, regulatory teams, and vendors to support study initiation, execution, and completion. Their work ensures smooth coordination between study sites and internal teams. Overall, this role contributes significantly to the development and evaluation of safe and effective medical devices.

Job Description

The Clinical Operations Associate is responsible for supporting the daily operations and documentation activities related to medical device clinical investigations. Professionals in this role manage clinical documentation files, ensure compliance with regulatory standards, and maintain organized clinical records for product clinical modules. The role also involves coordinating study activities such as regulatory document preparation, vendor coordination, and investigator meeting support. Additionally, clinical operations associates maintain study trackers, support clinical investigation documentation, and ensure that all study records are audit-ready according to regulatory guidelines. They also assist in communication with clinical sites and help track site documentation, payments, and operational updates to ensure smooth clinical study execution.

Key Features of the Role:

• Entry-level opportunity in medical device clinical research.
• Involvement in clinical investigation documentation and study operations.
• Exposure to global regulatory standards and clinical research processes.
• Opportunity to work with clinical sites, investigators, and research teams.
• Experience with clinical trial documentation and audit readiness.
• Position within the MedTech division of Zydus Lifesciences Limited.

Responsibilities

• Manage product clinical modules according to IMDRF STED Module V requirements.
• Create and maintain product clinical files and ensure periodic audit readiness.
• Maintain and update clinical risk management documentation.
• Ensure that all product clinical documentation is accurate and compliant for regulatory submissions.
• Create and maintain essential clinical investigation documentation files.
• Organize investigator site files and maintain proper document archiving.
• Support study metrics tracking, reporting, and dashboard creation.
• Assist with invoicing and payment management for clinical investigation sites.
• Coordinate regulatory document preparation including informed consent forms.
• Assist with investigator meetings and site initiation visits.
• Serve as a point of contact for administrative communication with clinical sites.
• Support audit preparation and ensure compliance with Good Clinical Practice guidelines.

Required Qualifications

• Strong understanding of clinical research documentation and regulatory compliance.
• Knowledge of clinical trial documentation standards.
• Ability to maintain accurate and organized clinical records.
• Strong attention to detail and analytical skills.

Educational Requirements

• Bachelor’s degree in medicine, pharmacy, nursing, or biomedical engineering.
• Master’s degree in life sciences such as biology, biotechnology, toxicology, or statistics may also be considered.

Experience and Skills

• Entry-level role suitable for fresh graduates or candidates with up to 1 year of experience.
• Experience as a Clinical Trial Assistant (CTA) or study coordinator is beneficial.
• Knowledge of medical device clinical investigation standards such as ISO 14155.
• Familiarity with Medical Device Rules 2017 preferred.
• Proficiency in Microsoft Office tools including Excel, Word, SharePoint, and OneDrive.
• Strong organizational and communication skills.

Salary Insights

Clinical Operations Associates in India typically earns depending on experience and organizational structure.

Company Overview

Zydus Medtech Private Limited is a healthcare company focused on developing innovative medical technologies and devices. The organization works on clinical research and regulatory development to bring safe and effective medical devices to the market. This role is based in Ahmedabad, a major pharmaceutical and biotechnology hub in India.

FAQs

• Who can apply for this role?
Candidates with life science, pharmacy, nursing, or biomedical engineering degrees.

• Is prior clinical research experience required?
No. This role is suitable for fresh graduates or candidates with minimal clinical research experience.

• What regulatory guidelines are relevant to this role?
The role involves compliance with ISO 14155, medical device regulations, and Good Clinical Practice guidelines.

• What type of organization offers this role?
Medical device companies, pharmaceutical companies, and contract research organizations.

Application Tips

• Highlight any clinical research, pharmacovigilance, or regulatory documentation experience.
• Mention knowledge of clinical trial processes and regulatory guidelines.
• Demonstrate strong documentation and organizational skills.
• Include proficiency in Microsoft Office tools such as Excel and SharePoint.
• Emphasize attention to detail and ability to manage multiple clinical documents.