Role Overview
The Manager, Clinical Operations is responsible for overseeing a team or functional group and ensuring successful performance and delivery of direct reports' project deliverables on time and to high-quality standards. The role combines people management, clinical research oversight, project delivery, resource planning, client management, business development support, and compliance responsibilities. The Manager may also participate directly as a senior contributor on project teams and is expected to work independently under the supervision of a Senior Manager, Associate Director, or Director.
Project Delivery Management & Oversight
Monitor team and project performance through close interaction with project leadership and functional leadership.
Ensure ongoing and revised project documentation and correspondence are accurate and complete.
Take responsibility for assigned project work as a senior-level project team contributor where required.
Ensure personal project deliverables are completed on time and with high quality.
Generate study-specific status reports for study teams, sponsors, and/or management as required.
Attend project team meetings at project level when required.
Provide consultation to management, project leadership, and project leads.
Facilitate collection of project metrics and develop action plans to maintain project timelines and budgets.
Manage and oversee team activities, including appropriate staff resourcing, assignments, quality control, and project-deliverable efficiency.
Develop accurate resource plans with appropriate project team members, including resource identification, assignment, and monitoring of ongoing resource requirements.
Act as an ongoing liaison between project teams, sponsors, management, and direct reports regarding performance.
Performance Management, Staff Development & Talent Management
Provide technical support and guidance to staff to ensure they possess the knowledge required to perform their duties.
Ensure direct reports meet departmental and project productivity and quality metrics.
Conduct quality checks of deliverables, including applicable site-visit outputs and Central File documentation.
Identify performance or quality issues and take appropriate remedial action.
Recruit, retain, and develop skilled, experienced, and motivated professionals to meet client expectations.
Manage and develop staff so their performance meets or exceeds business objectives and individual goals.
Train, mentor, and allocate staff according to their capabilities and project requirements.
Help employees improve efficiency, effectiveness, work prioritization, and overall performance.
Evaluate performance using work quality, client feedback, audit results, and quality-control measures.
Participate in formal employee review processes, including performance and salary reviews, according to corporate standards and timelines.
Client Management & Business Development
Support generation of business leads where appropriate through client networking, public speaking, and related activities.
Participate in and contribute to project bids and client presentations when assigned.
Coordinate client or account activities for the department or function where appropriate.
Review and take appropriate action following regular feedback sessions from client technical groups.
Build effective relationships with project teams, sponsors, clients, and internal management.
General Operations & Functional Management
Participate in or champion implementation of Parexel and departmental systems and standards improvement initiatives.
Maintain agreed levels of personal and team productivity/billability.
Monitor and support appropriate staff turnover levels.
Complete routine administrative activities accurately and on time, including timesheets, training requirements, and travel expense claims.
Travel as required by project or business needs.
Promote a positive, results-oriented working environment.
Build partnerships and model effective teamwork across the organization.
Communicate with team members in an open, balanced, and objective manner.
Maintain working knowledge of and ensure compliance with applicable ICH Guidelines, Good Clinical Practices, regulatory agency requirements, Parexel SOPs, and applicable sponsor SOPs.
Leadership & Role Modeling
May manage employees across multiple disciplines, particularly in smaller countries or locations.
Act as a role model for the assigned location.
May serve as a GMBA for a location or country where applicable.
Demonstrate leadership across the department, function, or location.
Take an active role in departmental, functional, and location activities such as management meetings.
Ensure employees follow corporate policies and coordinate appropriate follow-up with management.
Knowledge & Experience
Substantial clinical monitoring and/or data management experience, or equivalent clinical research experience.
Strong understanding and knowledge of the clinical trials environment.
Previous line-management experience is required.
Degree-level education is expected.
Biological science, pharmacy, another health-related discipline, equivalent nursing qualification, or relevant clinical/equivalent experience is preferred.
Communication Skills
Competency in the local language.
Strong written English skills.
Oral English competency is preferred.
Effective communication with direct reports, project teams, sponsors, clients, and management.
Core Competencies
Ability to manage and motivate direct reports.
Clinical research and clinical-trial operational knowledge.
Project delivery oversight.
Resource planning and allocation.
Quality control and performance management.
Staff development, mentoring, and training.
Client relationship management.
Business development and presentation support.
Regulatory and GCP compliance.
Risk identification and corrective action planning.
Leadership and cross-functional collaboration.
Working Environment
Primary location is Bengaluru, India.
Travel may be required according to project and business needs.
The role involves management responsibilities, project oversight, staff interaction, client engagement, and routine administrative activities.