Clinical Operations Manager/Senior

Parexel; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel is seeking a seasoned Project Delivery Manager to oversee project performance, provide leadership, and ensure high-quality deliverables across clinical development programs. The role emphasizes stakeholder engagement, budgeting, and staffing while maintaining regulatory compliance and standards.

The ideal candidate will have substantial experience in clinical research management, strong leadership skills, and a degree in a health-related field.

Qualifications

• Demonstrated ability to manage and motivate direct reports.
• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical experience.

Responsibilities

• Monitor performance with project leadership and ensure accurate documentation and correspondence.
• Provide consultation and action plans to keep projects on time and within budget.
• Produce resourcing plans and monitor resource needs across projects.
• Maintain compliance with ICH/GCP, SOPs and sponsor requirements.
• Lead and develop team to meet productivity and quality metrics.

Skills

People management

Education

Degree in biological sciences or pharmacy or related health discipline

Job description

When our values align, there’s no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world’s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we’re committed to making a difference.

Key Accountabilities:

Project Delivery Management and Oversight

• Monitor performance by close interaction with project leadership/functional leadership/client 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
• 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 and managers 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 team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives through training, mentoring and allocating team members 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
• Determine training needs and collaborate with appropriate learning and development organization to ensure availability of appropriate training

Client Management and Business Development

• May participate in and contribute to project bids, including client presentation’s
• May be responsible to coordinate client or account activities for department or function
• Take appropriate action following regular feedback sessions from client’s technical groups

General Operations and Functional/Business Unit Management

• Maintain and oversee team and departmental activities including appropriate resourcing of staff, staff assignments, quality control and efficiency of projects deliverables
• Participate in and/or champion the implementation of Parexel and department system/standards improvement activities including change management
• 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.
• Implement process improvements, in conjunction with Management team and the Quality Management Group, in response to client and team feedback and quality audits
• Look within and beyond CRS to encourage teamwork, quality and productivity efforts to the benefit of CRS and Parexel
• Revise, implement and monitor departmental compliance with SOPs

General Administration, Manage Personal Competencies and Role Modelling

• 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, or leading 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 written and oral English and local language.

Knowledge and Experience

• Substantial monitoring/data management experience or equivalent experience in clinical research with strong understanding & knowledge of clinical trials environment, with applicable experience in a management position.

Education:

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