Manager, Clinical Operations
Company: Parexel
Location: Mumbai, India
Department: Clinical Operations
Job Type: Full-Time
Work Mode: On-site / Hybrid
JOB OVERVIEW
The Manager, Clinical Operations is responsible for leading and managing Clinical Operations teams to ensure the successful delivery of clinical trials while maintaining high standards of quality, compliance, and operational excellence. The role involves project oversight, resource planning, team leadership, performance management, client engagement, business development support, and ensuring compliance with ICH-GCP, regulatory requirements, and company SOPs. The Manager also contributes to study execution, drives process improvements, mentors team members, and collaborates with cross-functional stakeholders to deliver clinical projects on time and within budget.
KEY RESPONSIBILITIES
Clinical Project Management
Oversee clinical operations activities across multiple clinical studies.
Ensure timely delivery of project milestones and deliverables.
Monitor project progress, timelines, budgets, and quality metrics.
Prepare study status reports for sponsors and management.
Participate in project meetings and provide operational leadership.
Project Oversight & Resource Management
Develop and maintain project resource plans.
Allocate resources based on project requirements and priorities.
Monitor team productivity and utilization.
Ensure projects are adequately staffed with qualified professionals.
Support quality control and operational efficiency across studies.
Clinical Operations Leadership
Lead and manage Clinical Operations teams.
Provide technical guidance and operational support to direct reports.
Ensure compliance with clinical study protocols and operational plans.
Promote collaboration across cross-functional project teams.
Drive continuous improvement in clinical operations processes.
Performance Management & Talent Development
Recruit, mentor, and develop Clinical Operations staff.
Conduct performance evaluations and career development discussions.
Support employee training and competency development.
Monitor productivity and quality performance metrics.
Foster a high-performance and collaborative team environment.
Client & Sponsor Management
Serve as a liaison between sponsors, project teams, and management.
Support client relationship management activities.
Participate in client meetings, project bids, and presentations.
Address client feedback and implement improvement initiatives.
Provide clinical and operational consultation when required.
Quality & Regulatory Compliance
Ensure compliance with ICH-GCP, regulatory guidelines, and company SOPs.
Perform quality oversight of clinical documentation and project deliverables.
Support audit and inspection readiness activities.
Monitor quality metrics and implement corrective actions.
Ensure complete and accurate clinical trial documentation.
Business Operations & Process Improvement
Contribute to organizational process improvement initiatives.
Support departmental operational planning and strategy.
Maintain productivity, billability, and staff retention targets.
Complete administrative responsibilities in a timely manner.
Participate in departmental and organizational leadership activities.
EDUCATIONAL QUALIFICATIONS
Preferred
Bachelor's Degree in:
Pharmacy (B.Pharm / M.Pharm)
Life Sciences
Biological Sciences
Biotechnology
Nursing
Medicine
Healthcare
Or another related health-related discipline
OR
Equivalent Nursing Qualification
Relevant Clinical Research Experience
EXPERIENCE REQUIREMENTS
Required
Significant experience in:
Clinical Operations
Clinical Monitoring
Clinical Research
Data Management
Clinical Trial Management
Preferred Experience
Team leadership and people management.
Clinical project management.
Resource planning and allocation.
Sponsor and client management.
Clinical trial delivery.
Performance management and mentoring.
Business development support.
Quality assurance and regulatory compliance.
Cross-functional collaboration.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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