Manager, Clinical Operations
Company: Parexel
Location: Bengaluru, India
Department: Clinical Operations
Job Type: Full-Time
Work Mode: Hybrid / Remote
JOB OVERVIEW
The Manager, Clinical Operations is responsible for leading and managing Clinical Operations teams to ensure the successful execution 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, quality assurance, and ensuring compliance with ICH-GCP, regulatory requirements, and company SOPs. The Manager also provides clinical consultation, mentors team members, and collaborates with cross-functional stakeholders to deliver clinical projects on time and within budget.
KEY RESPONSIBILITIES
Clinical Project Management
Oversee the execution of multiple clinical studies and project deliverables.
Monitor project timelines, budgets, and operational performance.
Prepare and review study status reports for sponsors and management.
Participate in project team meetings and provide operational leadership.
Ensure timely delivery of high-quality clinical trial deliverables.
Project Oversight & Resource Management
Develop and maintain project resource plans.
Allocate and manage resources based on project priorities.
Monitor staff utilization and project workload.
Coordinate staff assignments to ensure efficient project delivery.
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 study protocols, monitoring plans, and project requirements.
Promote collaboration across cross-functional project teams.
Drive continuous improvement of clinical operations processes.
Performance Management & Talent Development
Recruit, mentor, and retain high-performing Clinical Operations professionals.
Conduct performance evaluations and salary review processes.
Develop individual training and career development plans.
Monitor productivity and quality metrics for direct reports.
Foster a collaborative, motivated, and results-oriented work environment.
Client Management & Business Development
Serve as a liaison between sponsors, project teams, and management.
Support client relationship management and account activities.
Participate in project bids, proposals, and client presentations.
Address client feedback and implement continuous improvement initiatives.
Provide clinical consultation to project teams as required.
Quality & Regulatory Compliance
Ensure compliance with ICH-GCP, regulatory guidelines, and Parexel SOPs.
Perform quality reviews of project deliverables and documentation.
Support inspection and audit readiness activities.
Monitor compliance metrics and implement corrective actions.
Ensure complete and accurate clinical documentation throughout the study lifecycle.
Operational Excellence
Champion departmental and organizational process improvement initiatives.
Monitor productivity, billability, and staff retention.
Complete administrative responsibilities, including training, travel, and timesheets.
Promote teamwork, collaboration, and open communication.
Support departmental leadership and organizational initiatives.
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
Substantial experience in:
Clinical Operations
Clinical Monitoring
Clinical Research
Clinical Data Management
Clinical Trial Management
Preferred Experience
Team leadership and people management.
Clinical project management.
Resource planning and workforce management.
Sponsor and client management.
Clinical trial execution and oversight.
Performance management and mentoring.
Business development and proposal support.
Quality assurance and regulatory compliance.
Cross-functional collaboration
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