Clinical Trial Manager - FSP
Primary Location: Singapore 求人ID R0000035536 Category Clinical TrialsAbout this Role
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
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