Project Support Specialist

Summary

Join Precision for Medicine, a precision medicine CRO, as a Project Support Specialist! This fully remote position (UK, Spain, Hungary, Poland, Romania, Serbia, or Slovakia) offers cross-functional support within project teams, contributing to efficient study management. You will manage project timelines, schedules, and communications, maintain study data in various systems, and handle study supplies and materials. The role requires a 4-year degree or equivalent experience, at least 3 years of relevant experience, and proficiency in Microsoft Office and English. Strong communication, teamwork, and attention to detail are essential.

Requirements

• 4-year college degree, or equivalent experience ideally in a business, scientific or healthcare discipline
• Minimum of 3 years of relevant experience
• Fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)
• Customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)
• 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

Responsibilities

• Create and maintain the project timeline in MS Project or similar system. Ensure updates are captured and documented. Ensure the distribution of updates to study team members
• Schedule internal and external meetings, assist with preparing and circulating agendas, take meeting minutes, circulate meeting minutes, and file meeting agendas and minutes in the Trial Master File
• Perform an array of activities in the Clinical Trial Management System (CTMS) including maintaining study milestone dates, updating study contact lists, maintaining enrolment projections as needed, and submitting helpdesk tickets and ensuring remediation is completed
• Prepare, assign, and document study-specific training in appropriate systems; manage and oversee the maintenance of training records. Identify gaps in training and engage appropriate team members or escalate as needed
• Establish a study-level Share Point site or similar shared working space and ensure appropriate access to study team, sponsors and others as appropriate
• Create project-specific email boxes and maintain appropriate access to study team members
• Manage user access to study systems by submitting user requests to the HelpDesk or similar, by reviewing team member access on a define periodic basis, and document access review
• Order study supplies and address queries on study supplies
• Order initial study binders. Collect, collate and prepare study binders and ensure shipping to the proper locations through printing vendor
• Maintain various study trackers as needed and directed by the Project Manager, Clinical Trial Manager or other project leader
• Send communications to study sites, investigators and others, as directed by the Project Manager, Clinical Trial Manager or other Project Leadership, including SUSARs, email blasts, newsletters and other information that may be required
• May support the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable, may be under Safety staff guidance
• May support the translation process of site level documents, as applicable, per local and regional standards
• May act as point of contact for project-related requests for team members, Sponsors, and third party vendors
• Support the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable
• May support team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment)
• Perform other duties as assigned by the Project Manager, Clinical Trial Manager or other Project Leadership

Benefits

Fully home based working in the following locations: UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia