Key Accountabilities:

Operational Excellence

• Check quality of TMF team deliverables (e.g. TMF overview compliance with process and system steps, quality of queries) and propose appropriate remedial actions
• 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
• Liaise with functional senior management to provide and collect feedback on the process implementation  
• Support the development of SOPs and tools with Process Owners as necessary  
• Create and modify new/existing materials/job aides for TMF operations
• Serve as internal Subject Matter Expert for Parexel project teams, providing guidance and support during project implementation 
• Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)

Business & Financial Management

• Provide consultation, facilitate metrics collection and develop action plans in conjunction with Management/Project Leadership/Leads to keep projects on time and within budget
• Support development of materials and plans for TMF business opportunities and maintain the relevant libraries

Personal Ownership

• May be responsible for own assignments as SME. This includes taking the role of a senior level contributor on a project/account team and ensuring high quality and timely delivery of own deliverables.

Skills:

• Demonstrated ability to successfully manage the tasks.
• 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 provide guidance to other stakeholders as required.

Knowledge and Experience: 

• Substantial trial master file coordination experience or equal experience in clinical

Education:

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