Clinical Affairs Coordinator
Company: Zimmer Biomet
Location: Bengaluru, Karnataka, India
Department: Clinical Affairs
Job Type: Full-Time
Work Mode: Hybrid (2 Days WFH, 3 Days WFO)
JOB OVERVIEW
The Clinical Affairs Coordinator provides operational and administrative support to the Clinical Affairs team by coordinating clinical studies, maintaining clinical documentation, supporting regulatory compliance, managing study tracking activities, and facilitating communication with internal teams, vendors, and clinical sites. The role ensures accurate documentation, audit readiness, and smooth execution of clinical projects in compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements.
KEY RESPONSIBILITIES
Clinical Study Coordination
Coordinate day-to-day Clinical Affairs activities.
Track assigned clinical studies and project milestones.
Monitor study progress and follow up on pending activities.
Support post-market and clinical research projects.
Escalate study-related issues when required.
Clinical Documentation
Maintain Trial Master Files (TMF) and study documentation.
Organize clinical records and regulatory documents.
Ensure documentation is audit-ready.
Prepare and format clinical reports and study materials.
Maintain document version control and compliance.
Clinical Data & Reporting
Perform data entry and data verification.
Generate routine project and study reports.
Maintain study tracking logs and databases.
Support clinical metrics and reporting activities.
Ensure data accuracy and completeness.
Regulatory & Quality Compliance
Follow Good Clinical Practice (GCP) guidelines.
Maintain compliance with SOPs and regulatory requirements.
Support audit and inspection readiness.
Assist in quality and compliance activities.
Maintain confidential clinical information.
Vendor & Site Coordination
Coordinate communication with clinical sites and vendors.
Follow up on document collection and approvals.
Support vendor agreements and project coordination.
Facilitate timely exchange of study information.
Assist in issue resolution between stakeholders.
Financial & Administrative Support
Process invoices and reimbursement requests.
Track vendor payments and agreements.
Coordinate project-related financial documentation.
Support budgeting and administrative activities.
Maintain financial tracking records.
Meeting & Logistics Management
Coordinate project meetings and study logistics.
Prepare meeting agendas and presentation materials.
Record meeting minutes and action items.
Support site activities and project events.
Track follow-up actions until completion.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree
Preferred
Bachelor's Degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Biomedical Sciences, or a related healthcare field.
EXPERIENCE REQUIREMENTS
Required
Minimum 2 years of relevant experience.
Preferred
Clinical Research Support
Clinical Affairs
Healthcare Operations
Regulatory Affairs
Quality Coordination
Study Administration
Clinical Project Coordination
Clinical Trial Support
Post-Market Clinical Activities
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Remote, India | Siliguri |Illinois :
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