Trial Master File Manager

Manager, TMF

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:

Manage and oversee team activities

• Including appropriate resourcing of staff, staff assignments, and quality control of project deliverables and timely delivery of project deliverables.

Talent Management

• Meet and aim to exceed client expectations by recruiting, retaining and developing a skilled, experienced and motivated team.
• Train and mentor junior staff.
• Undertake the full range of duties relevant to the leadership, management, and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives.
• Participate in formal staff review processes e.g., performance and salary reviews to corporate standards and timescales.
• Support efforts for generating business leads (client networking, public speaking, etc.)

Performance Management

• Monitor performance close interaction with PL/GCO Lead and peers.
• Provide technical support to team members 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.
• Support team members to improve their efficiency and effectiveness at prioritizing work and improving performance evidenced by the work produced, Client feedback, audit results and QC measures.
• Serve as an ongoing liaison with Project Team, Sponsor, and management regarding performance of direct reports.
• Manage and develop the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives.

Business & Financial Management

• Maintain an agreed level of productivity/billability and staff turnover.
• Participate in and contribute to Project bids, including client presentations.
• Meet percentage of travel and billability guidelines for staff as appropriate.
• Provide consultation, facilitate metrics collection and develop action plans in conjunction with Management/Project Leadership/Leads to keep project on time and within budget.
• May be responsible to coordinate client or account activities for department or functions.
• May serve as GMBA for a location or country.
• May manage employees from multiple disciplines (e.g., in smaller countries) and act as a role model for location.
• Prepare and submit study specific status reports to Project Team, Sponsors and management and attend project team meetings.
• Serve as an ongoing liaison with Project Team, Sponsor, and management regarding performance of direct reports.
• Maintain a positive, results oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner.

Resource Management

• Meet client and business needs to have all projects optimally resourced with suitably experienced staff.
• Produce accurate resourcing plans in conjunction with the appropriate Project Team Members.

Operational Excellence

• Check quality of team deliverables (e.g. TMF overview) and take appropriate remedial action.
• Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and Parexel SOPs.
• Participate in Parexel and department system/standards improvement activities.
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims.

Personal Ownership

• May be responsible for own assignments as project team member or SME. This includes taking the role of a senior level contributor on a project team and ensuring high quality and timely delivery of own deliverables.
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
• 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 successfully manage the tasks.
• Advanced ability to manage and motivate direct reports.
• Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions).
• Advanced client focused approach to work.
• A flexible attitude with respect to work assignments and new learning.
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Ability to work in a matrix environment and to value the importance of teamwork.
• Excellent negotiation skills.
• Advanced in networking
• Excellent analytical and problem-solving skills.
• Ability to lead a “virtual” global team as required.

Knowledge and Experience:

• Substantial trial master file coordination experience or equal experience in clinical
• Prior experience in managing people

Education:

• Educated to a degree level (biological science, pharmacy or other health related discipline preferred) or relevant clinical or business equivalent

Experience Level

Mid Level