Manager, Clinical Operations

Parexel International; India; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Parexel International in India seeks an experienced Manager to oversee a team and ensure timely, high-quality project deliverables. You will resource client projects with appropriately developed professionals and contribute to business development through bids and client presentations.

The role requires strong leadership, clinical insight, and a track record in monitoring data management within the clinical trials environment. You will mentor staff and ensure adherence to regulatory standards.

Qualifications

• Substantial monitoring/data management experience in clinical research.
• Previous line management experience.
• Strong understanding of clinical trials environment.

Responsibilities

• Oversee a team to ensure on-time, high-quality project deliverables.
• Resource client projects with appropriately developed professionals.
• Promote new business by participating in project bids and client presentations.
• Provide clinical consultation to project teams as needed.
• Maintain compliance with ICH Guidelines, GCP, and sponsor SOPs.

Skills

Leadership

People management

Project coordination

Education

Degree in biological science / pharmacy or health-related discipline

Job description

The Manager is responsible for the oversight of a team or group. This includes ensuring successful performance and delivery of his/her direct report’s project deliverables, on time with high quality. The Manager is responsible to resource client projects with suitably developed professionals and to retain and develop these professionals within Parexel. The Manager may also be part of a project team and be responsible for successful delivery of his/her own project deliverables, on time with high quality. The Manager is responsible to promote new business by participating in project bids and client presentations as appropriate. The Manager is responsible to provide clinical consultation to project teams as needed. The Manager works independently, under supervision of the Senior Manager, Associate Director or Director.

Key Accountabilities

Project Delivery Management and Oversight

• Monitor performance by close interaction with project leadership/functional leadership and ensure that ongoing/revised project documentation and correspondence is accurate and complete.
• May be responsible for own assignments as project team member. This may include but not limited to taking the role of a senior level contributor on a project team and ensuring high quality and timely delivery of own deliverables, generating study specific status reports for study teams, Sponsors and/or management, and attend project team meetings as required at the project level
• Provide consultation, facilitate metrics collection and develop action plans in conjunction with Management/Project Leadership/Leads to keep project on time and within budget.
• Manage and oversee team activities including appropriate resourcing of staff, staff assignments, quality control and efficiency of project deliverables
• Where assigned, produce accurate resourcing plans in conjunction with appropriate Project Team Members, including but not limited to facilitating appropriate resource identification and assignment, and monitoring resource needs throughout the project as needed.
• Serve as an ongoing liaison with Project Team, Sponsor and management regarding performance of direct reports.

Performance Management, Staff Development and Talent Management

• Provide technical support to staff to ensure that they have the required knowledge to fulfill their duties
• Ensure direct reports meet departmental and project productivity and quality metrics by efficient execution of their project in line with project plan by conducting quality check of deliverables (e.g., on site visits, Central File documentation) and take appropriate remedial action
• Meet and aim to exceed client expectations by recruiting, retaining and developing a skilled, experienced and motivated team
• Manage and develop the staff to ensure their performance meets and or exceeds both the business and their own personal goals/objectives through training, mentoring and allocating staff according to their ability
• Support staff to improve their efficiency and effectiveness at prioritizing work and improving performance evidenced by the work produced, client feedback, audit results and QC measures
• Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales

Client Management and Business Development

• Where appropriate, may be tasked support efforts for generating business leads (client networking, public speaking, etc.)
• Where appropriate, may participate in and contribute to Project bids, including client presentations
• Where appropriate, may be responsible to coordinate client or account activities for department or function
• Where appropriate, take appropriate action following regular feedback sessions from client’s technical groups

General Operations and Functional/Business Unit Management

• Participate in and/or champion the implementation of Parexel and department system/standards improvement activities
• Maintain an agreed level of productivity/billability and staff turnover
• Complete routine administrative tasks in a timely manner (e.g. timesheets, training, travel expense claims). Travel as needed.
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
• Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, Parexel SOPs, and where applicable, sponsor SOPs.

General Administration, Manage Personal Competencies and Role Modeling

• May manage employees from multiple disciplines (e.g., in smaller countries) and act as role model for location. May serve as GMBA for a location or country
• Demonstrate leadership within department, function or location. This includes taking an active role in departmental, functional or location activities (e.g., management meetings), ensuring employees adhere to corporate policies and following up with management as appropriate

Skills

• Demonstrated ability to manage and motivate direct reports.

Language Skills

• Competent in local language and written English. Oral English competency is preferred.

Knowledge and Experience

• Substantial monitoring/data management experience or equivalent experience in clinical research with strong understanding & knowledge of clinical trials environment.
• Previous line management experience

Education

• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experience.