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
