Senior / Manager (Clinical Trials Contract)

Singapore General Hospital; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A major healthcare institution in Singapore is seeking a Senior / Manager to enhance their clinical trial program. The role requires overseeing the review of clinical trial contracts, ensuring compliance with various regulations, and leading a team during contract negotiations. Ideal candidates have at least 6 years of relevant experience, strong communication skills, and a solid understanding of clinical trial processes. This position offers an opportunity to contribute significantly to the advancement of clinical research.

Qualifications

• More than 6 years of relevant experience in negotiating clinical trial contracts.
• Preference for knowledge of clinical trial conduct procedures.
• Well versed in laws and regulations applicable to trial conduct.

Responsibilities

• Assist in reviewing clinical trial contracts with the legal department.
• Keep track of agreement timelines and manage replies.
• Supervise the Feasibility Team during negotiations.

Skills

Negotiating clinical trial contracts

Strong communication skills

Leadership and management

Knowledge of clinical trial conduct procedures

Team collaboration

Education

Recognised degree

Job description

We are looking for a Senior / Manager with sufficient professional experience and skills to fulfill a specialist role that can contribute to the development of the clinical trial program within National Cancer Centre Singapore (NCCS). 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 PeopleConnexion (SuccessFactors) 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.