Precision For Medicine

Project Support Specialist

Precision For Medicine

full-time

Posted on:

Location: 🇬🇧 United Kingdom

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Job 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