Senior Clinical Project Associate
Location: Bangalore, India
Department: Clinical Operations / Clinical Project Management
Employment Type: Full-Time
Position Overview
The Senior Clinical Project Associate (Sr CPA) plays a critical role in supporting clinical study operations, project coordination, documentation management, quality oversight, and process compliance across global clinical research programs.
This position serves as a key operational resource within the Clinical Operations team, ensuring efficient execution of study maintenance activities, timely completion of project deliverables, regulatory compliance, and adherence to quality standards. The role requires strong organizational skills, attention to detail, stakeholder coordination, and the ability to manage multiple priorities in a dynamic clinical research environment.
The Senior Clinical Project Associate acts as a subject matter resource for assigned processes while supporting continuous improvement initiatives and operational excellence across clinical projects.
Key Responsibilities
Clinical Project Support
Support day-to-day clinical project activities across assigned studies and programs.
Coordinate study maintenance activities and ensure timely completion of project deliverables.
Assist project teams with operational, administrative, and technical support requirements.
Ensure project activities are executed in accordance with approved timelines and quality standards.
Collaborate with internal stakeholders to support efficient study execution.
Documentation Management
Manage clinical project documentation in compliance with:
Standard Operating Procedures (SOPs)
Work Instructions (WIs)
Regulatory Requirements
Internal Quality Standards
Maintain accurate and complete project records.
Ensure study documentation is organized, updated, and audit-ready.
Support document tracking, review, and archival activities.
Quality & Compliance Oversight
Perform quality checks and reviews to ensure accuracy and completeness of work.
Monitor compliance with departmental procedures and operational standards.
Address quality findings and implement corrective actions within required timelines.
Ensure responses to QC review comments are completed promptly.
Support inspection readiness and quality improvement initiatives.
Study Maintenance & Operational Coordination
Coordinate workload assignments and ensure completion of assigned activities within established timelines.
Monitor task progress and proactively escalate issues that may impact project delivery.
Support issue resolution through collaboration with project teams and management.
Act as a key operational contact for process-related inquiries.
Partner with Subject Matter Experts (SMEs) to provide guidance and support to team members.
Metrics & Reporting
Track project and operational metrics as defined by management.
Maintain accurate records within daily task trackers and reporting systems.
Monitor productivity, quality, and compliance indicators.
Identify discrepancies in reported data and escalate issues when necessary.
Prepare reports and updates for management review.
Training & Team Support
Complete all assigned training programs within required timelines.
Support training compliance initiatives across the team.
Collaborate with Quality Assurance and Development teams to maintain training records.
Ensure team training files remain current and compliant.
Provide process guidance and knowledge-sharing support to colleagues.
Process Improvement & Operational Excellence
Participate in continuous improvement initiatives.
Identify opportunities to enhance workflow efficiency and quality.
Support implementation of revised processes, procedures, and system enhancements.
Contribute ideas to improve productivity, compliance, and operational effectiveness.
Promote best practices across study maintenance activities.
Leadership & Subject Matter Support
Serve as a primary point of contact for process-related questions within the team.
Support managers and SMEs in driving process consistency and operational excellence.
Act as a role model by demonstrating strong technical expertise, professionalism, and accountability.
Foster a culture of quality, collaboration, and continuous improvement.
Provide support for additional projects and initiatives as assigned by management.
Required Qualifications
Education
Bachelor’s Degree in:
Life Sciences
Biotechnology
Pharmacy
Clinical Research
Biomedical Sciences
Healthcare Sciences
Related Scientific Discipline
Experience
Required
Minimum 4 years of experience in:
Clinical Research
Clinical Operations
Clinical Trial Support
Study Maintenance
Clinical Project Coordination
Preferred
CRO (Contract Research Organization) experience.
Experience supporting global clinical studies.
Experience working in regulated clinical environments.
Exposure to project coordination and quality management processes.
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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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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