Clinical Operations Job at Zydus
A rare chance has emerged for aspiring Clinical Operations Associates at Zydus MedTech in Ahmedabad. This Clinical Operations Job at Zydus MedTech Careers in Ahmedabad is ideal for candidates with over a year of experience in clinical trial administration or study coordination, specifically within the medical device or CRO sectors. Interested applicants are encouraged to apply before the deadline.
About Zydus MedTech
Zydus MedTech is a prominent player in the medical device industry, operating under the Zydus Group, which is headquartered in Ahmedabad, Gujarat, India. The organization is dedicated to innovation and excellence in healthcare, focusing on the development and commercialization of medical technologies that enhance patient care and outcomes.
- Company: Zydus MedTech
- Location: Ahmedabad, Gujarat, India
Job Description
The Clinical Operations Associate (COA) will play a vital role in supporting the daily operations and clinical documentation of products, ensuring compliance with ISO 14155:2020 and other relevant regulations. The COA will be responsible for maintaining accurate and organized documentation, facilitating clinical investigations, and ensuring audit readiness.
Key Responsibilities
- Manage product clinical modules in accordance with IMDRF STED Module V.
- Create and maintain essential clinical investigation documentation files (ECIDF) and investigator site files (ISF).
- Assist in the preparation and submission of regulatory documents, including informed consent forms, in the Clinical Operations Job.
- Coordinate with vendors for clinical supplies and assist with investigator meetings.
- Act as a liaison for clinical sites regarding administrative requests and support payment tracking in this Job in Ahmedabad.
- Review study documents for accuracy and assist with audit preparations.
- Support the creation and maintenance of study metrics trackers and reports.
- Manage invoicing and payments for clinical investigations at Zydus Careers.
Eligibility Criteria for the Clinical Operations Job
- Education: Bachelor’s degree in pharmacy, or a Master’s degree in a relevant life sciences field.
- Experience: Minimum 1 year as a CTA, Study Coordinator, or similar role within a medical device company or CRO.
- Knowledge: Strong understanding of ISO 14155:2020 and India MDR Schedule 7.
Required Skills
- Proficiency in Microsoft Office Suite (OneDrive, SharePoint, Excel, and Word).
- High attention to detail and accuracy in document review.
- Excellent communication skills for interacting with stakeholders.
- Strong organizational skills to manage multiple tasks and meet deadlines.
