Job Summary:
The Clinical Operations professional is responsible for supporting the planning, execution, and oversight of clinical trials in accordance with study protocols, applicable regulations, Good Clinical Practice (GCP), and company procedures. The role involves coordinating study activities, working with cross-functional teams and clinical sites, tracking timelines and documentation, and ensuring that clinical studies are conducted efficiently and to the required quality standards.
Key Responsibilities
- Support the planning, initiation, conduct, and close-out of clinical trials.
- Coordinate activities across Clinical Operations, Clinical Research, Data Management, Biostatistics, Regulatory Affairs, Medical Affairs, and other teams.
- Assist with site identification, selection, activation, and ongoing communication.
- Track study milestones, timelines, enrollment, and operational deliverables.
- Support preparation and maintenance of essential clinical trial documents and Trial Master File (TMF).
- Ensure study activities are conducted in compliance with protocols, GCP, SOPs, and applicable regulatory requirements.
- Assist with study monitoring activities and follow up on site action items.
- Manage communication with clinical investigators, site staff, vendors, and other stakeholders.
- Support clinical trial vendors and external service providers, including tracking deliverables and performance.
- Identify operational risks, issues, and deviations and escalate them appropriately.
- Participate in study meetings and prepare agendas, minutes, trackers, and status reports.
- Support inspection and audit readiness activities.
- Review and maintain study-related documentation, reports, and correspondence.
- Contribute to process improvement initiatives within Clinical Operations.
Required Qualifications
- Qualification:BAMS,BHMS.
- Experience in clinical research, clinical operations, clinical trials, or a related pharmaceutical/CRO environment is preferred.
Interested candidate please contact below mentioned number:9048003749
Pay: ₹20,000.00 - ₹25,000.00 per month
Work Location: In person
