Project Team Lead / Assistant Project Manager (Clinical Trials)

We are looking for an Assistant Project Manager / Project Team Lead for the Division of Clinical Trials & Epidemiological Sciences - Clinical Trials Office (CTE-CTO) within NCCS.

This role will manage multi-site investigator-initiated trials (IITs) from start-up to close-out. The role is required to liaise with multiple stakeholders to set up the IITs and ensure their smooth operations, in compliance with institutional and legislated regulatory requirements.

The role will also perform quality checks on NCCS site’s clinical trial documentation (ISFs, participant binders) of industry-sponsored trials and IITs to ensure they are conducted in compliance with GCP, institutional SOPs and regulatory requirements; and assist with other tasks for the department as assigned.

Key Responsibilities:

1. Manage regional/ local multi-site clinical trials (investigator-initiated)

• Monitor trial progress and ensure trial operates within budget and timeline
• Do budget forecasts
• Assist PI in obtaining funding from industry partners and/or grants, including contracting and grant application/ extension
• Manage timely funding and payment throughout trial duration
• Liaise with vendors throughout trial duration (for outsourced activities such as site monitoring, biological samples testing, data management), including contracting, setting up processes, developing manuals and issue resolution
• Manage clinical supplies (investigational product, lab kits) throughout trial duration
• Review and maintain trial master file
• Work closely with sites as the main point of contact for operational activities including but not limited to contract execution, site payments, biological samples and data collection, safety reviews, clinical supplies, issue resolution, data cleaning and publication
• Anticipate risks and take action to mitigate/avoid them, where applicable

2. Perform quality checks on site clinical trial documentation

• Review ISF and participant binders for adherence to ALCOA principles, trial protocol and regulatory requirements.
• Assist NCCS site in audits and inspections by working with site team on preparatory work and CAPA plans.

3. Assist with various tasks for the department as assigned

• May include but not limited to developing/ reviewing department SOPs and Work Instructions.
• Tracking staff training.

Requirements:

• Degree in life science, or related discipline
• At least 4 years of clinical trial experience, including minimum 1 year of clinical trial management experience.
• CRA experience is required.
• Meticulous with close attention to timelines
• Able to handle multiple priorities independently
• Strong organisational skills, interpersonal skills
• Committed team player
• Able to assess situations independently and recommend solutions
• Fluent in both written and spoken English
• Proficient in Microsoft Excel, Word and PowerPoint