Senior / Manager, Clinical Trial Contracts

About the role

SingHealth is looking for a Senior / Manager with sufficient professional experience and skills to contribute to the development of the clinical trial programme at National Cancer Centre Singapore (NCCS). The role mainly assists the Clinical Trials Office in reviewing and finalising contracts for clinical trials for the Division of Clinical Trials & Epidemiological Sciences (CTE).

Key responsibilities

• Review clinical trial contracts and work with the SingHealth Legal Department to negotiate agreement terms with commercial sponsors, CROs, academic institutions or international trial groups.
• Check hard-copy contract documents and obtain signatures from NCCS signatories.
• Track agreement timelines and follow up on parties who have not replied after two weeks.
• Supervise and advise the Feasibility Team executives on NDA negotiations and act as backup during manpower shortages.
• Approve online payments in APIMS, training applications in People Connexion (SuccessFactors) and other assigned online applications.
• Oversee financial and insurance reporting to CTCC and annual NMRC reporting.
• Assist in submitting and updating clinicaltrials.gov, check and approve archiving costs and payments to the archiving company and MRO.
• File and maintain executed contracts securely to protect confidentiality.
• Carry out other duties assigned by supervisors or the Clinical Trials Office management.

Required profile

• A recognised degree with at least 6 to 8 years of experience negotiating clinical trial contracts or research study contracts, plus experience supervising staff.
• Good knowledge of clinical trial conduct procedures preferred.
• Strong communication and writing skills, good command of language, strong people skills and teamwork.
• Strong leadership and management skills; meticulous, sharp and driven.

Required skills

• Knowledge of HBRA, Health Products and Medicines Act, Health Product (Clinical Trial) Regulation, PDPA and ICH GCP.
• Negotiation of clinical trial contracts and NDAs.