Assistant / Manager (Clinical Trial - Contracts)

NATIONAL CANCER CENTRE OF SINGAPORE PTE LTD; Singapore; On-site; SGD 70,000 - 100,000; Full time

Job summary

A leading clinical research institution is seeking an Assistant / Manager to enhance the clinical trial program. Key responsibilities include negotiating contracts, supervising staff, and ensuring compliance with regulatory standards. The ideal candidate holds a recognised degree and has extensive experience in clinical trial management.

Qualifications

• At least 6 to 8 years of relevant experience in negotiating clinical trial contracts.
• Good knowledge of clinical trial conduct procedures.
• Well versed in relevant laws and regulations applicable to trial conduct.

Responsibilities

• Assist in reviewing clinical trial contracts and negotiating terms with sponsors and CROs.
• Track agreement timelines and follow up on replies.
• Supervise the Feasibility Team during peak times.

Skills

Negotiation

Communication

Leadership

Teamwork

Education

Recognised degree

Job description

We are looking for an Assistant / Manager with sufficient professional experience and stature to fulfill a specialist role that can contribute to the development of the clinical trial program within National Cancer Centre Singapore. The role will mainly assist our Clinical Trials Office to review and finalize contracts related to clinical trials for the Division of Clinical Trials & Epidemiological Sciences (CTE).

Main Duties:

• Assist to review clinical trial contracts and work closely with the SingHealth Legal Department to negotiate agreement terms with commercial sponsors, CROs, academic institutions or international trial groups.
• Assist in checking hard copy contract documents and obtaining signatures from the NCCS’s signatories.
• Keep track of agreement timelines and chase for replies if a party has not replied for the past two weeks.
• Supervise and provide advice to the executives of the Feasibility Team in NDA negotiation and to act as back-up for such review and negotiation during manpower shortage.
• Assist in approving online payments in APIMS, training applications in People’s Connexion and any other online applications assigned.
• Help to oversee financial and insurance reporting to CTCC as well as annual NMRC reporting.
• Assist in submission and updating of the clinicaltrials.gov, check and approve archiving costs and payment to archiving company and MRO.
• File and maintain executed contracts and ensure these are stored securely to maintain confidentiality and prevent loss or damage.
• Perform any other duties assigned by the supervisors or the Clinical Trials Office higher management staff

Main Requirements:

• A recognised degree, with at least 6 to 8 years of relevant experience in negotiating clinical trial contacts or research study contracts as well as experience in staff supervision.
• Preference for individuals with good knowledge of clinical trial conduct procedures.
• Well versed in relevant laws and regulations applicable to trial conduct including HBRA, Health Products and Medicines Act, Health Product (Clinical Trial) Regulation, PDPA and ICH GCP.
• Strong communication and writing skills, good command of language, good people skills and strong ability to be a good team player.
• Strong leadership and management skills.
• Meticulous, sharp and driven