Clinical Operations Manager – FSP 360
Location: Pune, India
Work Mode: Hybrid
Department: Clinical Operations
Employment Type: Full-Time
Job Overview
We are seeking an experienced Clinical Operations Manager – FSP 360 to lead clinical operations teams, ensure successful customer delivery, drive operational excellence, and manage resource planning within a Functional Service Provider (FSP) environment. This role is responsible for overseeing clinical operations performance, maintaining compliance standards, managing stakeholder relationships, and supporting business growth through effective team leadership.
The ideal candidate will possess strong expertise in clinical trial operations, people management, customer engagement, compliance oversight, and strategic resource planning within the pharmaceutical, biotechnology, CRO, or clinical research industry.
Key Responsibilities
Customer Delivery and Client Success
Develop and maintain strong relationships with customers and key stakeholders.
Act as a primary point of contact for operational and service delivery matters.
Gather customer feedback and implement continuous improvement initiatives.
Ensure successful delivery of agreed Key Performance Indicators (KPIs).
Develop mitigation and remediation plans to address performance gaps and compliance issues.
Proactively manage customer concerns through established escalation processes.
Support customer satisfaction and long-term partnership objectives.
Clinical Operations Oversight
Ensure compliance with:
ICH-GCP Guidelines
Standard Operating Procedures (SOPs)
Work Instructions (WIs)
Local and international regulatory requirements
Conduct operational oversight activities and site monitoring reviews as required.
Ensure team adherence to training requirements and documentation standards.
Monitor operational metrics and implement corrective actions when necessary.
Oversee system updates and ensure compliance with operational processes.
Resource and Workforce Management
Manage team headcount and workforce planning activities.
Identify resource requirements and support timely recruitment efforts.
Create and manage job requisitions aligned with project and business needs.
Ensure appropriate allocation of resources to meet customer deliverables.
Balance team size, capabilities, and workload demands effectively.
Business Performance and Growth
Support achievement of business unit revenue and operational targets.
Contribute to knowledge-sharing initiatives and best practice implementation.
Utilize operational data and metrics to drive informed decision-making.
Support process optimization and continuous improvement initiatives.
Represent the organization at professional meetings, conferences, and industry events when required.
People Leadership and Team Development
Lead, coach, and manage clinical operations team members.
Conduct performance management activities and development discussions.
Support employee engagement, retention, and career development initiatives.
Identify training needs and ensure completion of required learning activities.
Delegate responsibilities aligned with employee skills and development goals.
Foster a collaborative, high-performance team culture.
Administrative Management
Oversee administrative processes, including:
Performance documentation
Timecard approvals
Expense management
Training records maintenance
HR-related processes
Ensure accurate and timely completion of operational documentation.
Diversity, Equity, and Inclusion
Promote an inclusive and respectful work environment.
Support diversity and equity initiatives across the team.
Encourage unbiased decision-making and equal growth opportunities for all employees.
Required Qualifications
Education
Bachelor's Degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, Healthcare Management, Nursing, or a related discipline.
Master's Degree preferred.
Experience
Significant experience in Clinical Operations, Clinical Trial Management, Site Management, Clinical Monitoring, or FSP Operations.
Prior experience leading clinical research teams and managing customer-facing operations.
Experience working within CRO, pharmaceutical, biotechnology, or healthcare research organizations.
Uttar Pradesh :
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