Senior Assistant Project Manager / Project Manager (Clinical Trials Office)
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 trial (IIT) from start-up to close-out. The ideal candidate is required to liaise with multiple stakeholders to set up the IIT, ensure its smooth operation and compliance with institutional and legislated regulatory requirements.
He/She will also perform selected 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.
Key Responsibilities:
1. Project manage multi-site clinical trials (investigator-initiated)
- Monitor trial progress and ensure trial operates within budget and timeline
- Do budget forecasts
- May 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/ reviewing manuals and issue resolution
- Liaise with drug company/ vendors to 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 P&Ps and Work Instructions, and tracking staff training.
Key Requirements:
- Degree in life science, biomedical sciences or any related study.
- 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 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