Project Support Specialist
Precision For Medicine
Google Cloud Platform
Project Support Specialist
Precision For Medicine
full-time
Posted on:
Origin: • 🇬🇧 United Kingdom
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- Create and maintain project timelines in MS Project or similar and distribute updates to study team members
- Schedule internal and external meetings, prepare and circulate agendas, take and circulate meeting minutes, and file agendas/minutes in the Trial Master File
- Perform activities in the Clinical Trial Management System (CTMS): maintain study milestone dates, update contact lists, maintain enrolment projections, submit helpdesk tickets and manage remediation
- Prepare, assign, and document study-specific training and manage training records; identify training gaps and escalate as needed
- Establish and manage study-level SharePoint sites or similar shared working spaces and ensure appropriate access
- Create and maintain project-specific email boxes and user access to study systems; perform periodic access reviews and document them
- Order study supplies, initial study binders, collect/collate/prepare binders and coordinate shipping through printing vendor
- Maintain various study trackers and support communications to study sites, investigators and sponsors (including SUSARs, newsletters, email blasts)
- Support distribution/tracking of IND Safety Reports/SUSARs/CIOMS as applicable and under Safety staff guidance
- Support translation process for site level documents as applicable
- Act as point of contact for project-related requests for team members, Sponsors, and third party vendors
- Support preparation, distribution, and reconciliation of study material (Operations Manual, ISF, patient cards, etc.)
- Support production of study reports and updates (e.g., country/site initiation, activation, recruitment)
- Perform other duties as assigned by Project Manager, Clinical Trial Manager or Project Leadership
Requirements
- 4-year college degree, or equivalent experience ideally in a business, scientific or healthcare discipline
- Minimum of 2 years of relevant experience as a Clinical Trial Assistant, Clinical Support Specialist or similar position
- Fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)
- Ability to communicate both verbally and in writing at the English proficiently (Professional level)
- Working knowledge of ICH-GCP, Precision SOPs, and regulatory guidance
- Customer service demeanour; demonstrate flexibility, teamwork, and a keen attention to detail
- Demonstrates solid interpersonal skills and strong written and verbal communication skills
- Strong self-motivation, detail-oriented and able to work and plan independently as well as in a team environment
- Experience with MS Project or similar project timeline tools
- Experience using a Clinical Trial Management System (CTMS), SharePoint or similar shared working spaces, and HelpDesk/ticketing processes
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