Senior Assistant Project Manager

2 weeks ago

Singapore KK Women's & Children's Hospital Full time
Overview

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

This role will manage multi-site investigator-initiated trials (IIT) from start-up to close-out. The ideal candidate will liaise with multiple stakeholders to set up IITs, ensure smooth operation, and maintain compliance with institutional and legislated regulatory requirements.

The position will include performing selected quality checks on NCCS site's clinical trial documentation (ISFs, participant binders) of industry-sponsored trials and IITs to ensure adherence to GCP, institutional SOPs, and regulatory requirements.

Responsibilities
  1. Project manage multi-site clinical trials (investigator-initiated)
    • Monitor trial progress and ensure trials operate within budget and timeline
    • Conduct budget forecasts
    • Assist Principal Investigator in obtaining funding from industry partners and/or grants, including contracting and grant applications/extensions
    • Manage timely funding and payments throughout the trial duration
    • Engage with vendors for outsourced activities (site monitoring, biological samples testing, data management), including contracting, setting up processes, developing/reviewing manuals, and issue resolution
    • Coordinate with drug companies/vendors to manage clinical supplies (investigational product, lab kits) throughout the trial
    • Review and maintain the Trial Master File
    • Serve as the main operational point of contact for sites, including contract execution, site payments, data collection, safety reviews, clinical supplies, issue resolution, data cleaning, and publication
    • Anticipate risks and take actions 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 sites in audits and inspections by coordinating with site teams on preparatory work and CAPA plans
  3. Assist with various tasks for the department as assigned
    • May include developing/reviewing department P&Ps and Work Instructions, and tracking staff training
Key Requirements
  • Degree in life science, biomedical sciences or any related field
  • At least 4 years of clinical trial experience, including a minimum of 1 year of clinical trial management experience
  • CRA experience is required
  • Meticulous with close attention to timelines
  • Able to handle multiple priorities independently
  • Strong organizational skills
  • Strong communication and 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
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