The Manager (CTE-CTO) shall have sufficient professional experience to fulfill a specialist role in contributing to the development of the clinical trial program at NCCS. The Manager shall also assist the Senior Manager / Principal Clinical Research Coordinator (PCRC) to plan and manage the operations of the Clinical Trials Office (CTO) of the Division of Clinical Trials & Epidemiological Sciences (CTE).
The Manager has to ensure that clinical trials are performed in accordance with applicable guidelines such as the protocol, Good Clinical Practice (GCP) Guidelines, all applicable regulatory requirements and the Clinical Trials office’ Standard Operating Procedures.
Major Duties And Responsibilities (90%)
- Obtain sufficient information from study protocols and industry sponsors, obtain costings from relevant divisions/departments involved and assist in budget drafting for studies. Negotiate with the sponsors on the pricing and the type or number of patient assessments to be included in the budget.
- Assist Senior Manager / Principal Clinical Research Coordinator (PCRC) to create training plan for CTE-CTO. The Manager shall be involved in the training of staff and recommend staff for external courses. The Manager will monitor the progress and outcome of training to ensure competency, obtain feedback and ensure documentation of all training provided.
- Assist to ensure proper supervision of staff and operations of CTE-CTO. This includes monitoring of individual work progress and providing assistance whenever necessary, solving and giving advice on problems associated with procedures, communications, teamwork or working relations with other departments, time management, limited resources etc.
- Assist in ensuring that CTE-CTO has sufficient Standard Operating Procedures (SOPs) to guide its operations. The Manager shall write SOPs or supervise the drafting of SOPs for CTE-CTO.
Minor Duties And Responsibilities (10%)
- The Manager may be involved in drafting and reviewing of department P&Ps.
- Perform any other duties assigned by the supervisors or the Clinical Trials Office higher management staff
Requirements:
- A recognised degree, with at least 10 – 15 years of relevant healthcare or research setting.
- Possess breadth of knowledge and experience in relevant research regulations (HBRA, Health Products and Medicines Act) and Good Clinical Practice.
- Strong communication skills, good EQ, strong ability to be a good team player.
- Strong leadership and management skills.
- Meticulous and responsive with excellent communication and writing skills.
