Project Support Specialist
Precision Medicine Group
Google Cloud Platform
Project Support Specialist
Precision Medicine Group
full-time
Posted on:
Origin: • 🇬🇧 United Kingdom
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- Creates and maintains the project timeline in MS Project or similar system; ensures updates are captured, documented and distributed to study team members.
- Schedules internal and external meetings; prepares and circulates agendas; takes and circulates meeting minutes; files agendas and minutes in the Trial Master File.
- Performs activities in the Clinical Trial Management System (CTMS) including maintaining study milestone dates, updating contact lists, maintaining enrolment projections, and submitting helpdesk tickets.
- Prepares, assigns, and documents study-specific training; manages and oversees maintenance of training records; identifies training gaps and engages or escalates as needed.
- Establishes study-level SharePoint or similar shared working spaces and manages appropriate access for team, sponsors, and others.
- Creates project-specific email boxes and maintains appropriate access for study team members.
- Manages user access to study systems by submitting user requests, reviewing team member access periodically, and documenting access reviews.
- Orders study supplies and initial study binders; collects, collates and prepares study binders and ensures shipping via printing vendor.
- Maintains various study trackers as directed by Project Manager or Clinical Trial Manager.
- Sends communications to study sites, investigators and others as directed, including SUSARs, email blasts, newsletters, and other required information.
- May support distribution and tracking of IND Safety Reports/SUSARS/CIOMS under Safety guidance as applicable.
- May support translation process of site level documents per local and regional standards.
- May act as point of contact for project-related requests from team members, Sponsors, and third party vendors.
- Supports preparation, distribution, and reconciliation of study material during applicable study phases (Operations Manual, ISF, patient cards, etc.).
- May support production of various study reports and updates (e.g., country/site initiation, activation, recruitment).
- Performs other duties as assigned by Project Manager, Clinical Trial Manager or other 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).
- Customer service demeanour; demonstrate flexibility, teamwork, and a keen attention to detail.
- Ability to communicate both verbally and in writing at the English proficiently (Professional level). Competencies:
- Working knowledge of ICH-GCP, Precision SOPs, and regulatory guidance.
- Demonstrates solid interpersonal skills.
- Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment.
- Strong written and verbal communication skills
- Commitment to performing professionally consistent with Precision Principles.
