Project Support Specialist

📋 Description

• • The Project Support Specialist at Precision Medicine Group plays a critical role in enabling the efficient execution of clinical trials in oncology and rare diseases by providing cross-functional administrative and operational support to project teams, ensuring timelines, documentation, training, and communication are meticulously managed to uphold study integrity and regulatory compliance.
• • This role directly contributes to accelerating precision medicine initiatives by maintaining the operational backbone of clinical trials, allowing scientific and medical teams to focus on innovation while the specialist ensures seamless coordination across internal and external stakeholders.
• • Day-to-day responsibilities include creating and maintaining project timelines in MS Project or similar systems, ensuring timely updates are documented and distributed to study teams; scheduling internal and external meetings, preparing agendas, taking and circulating minutes, and filing them in the Trial Master File.
• • The specialist performs essential Clinical Trial Management System (CTMS) activities such as updating study milestone dates, managing contact lists, tracking enrolment projections, and submitting and following up on helpdesk tickets to ensure system integrity and issue resolution.
• • They prepare, assign, and document study-specific training in appropriate systems, maintain training records, identify gaps, and escalate needs to ensure team competency and compliance with ICH-GCP and company SOPs.
• • The role involves establishing and managing study-level SharePoint sites or shared workspaces, configuring appropriate access for study teams, sponsors, and vendors, and creating and maintaining project-specific email boxes with proper permissions.
• • User access management is a key function, including submitting access requests via HelpDesk, conducting periodic access reviews, and documenting outcomes to ensure system security and compliance.
• • Logistical duties include ordering study supplies and initial study binders, collecting, collating, preparing, and shipping binders via printing vendors to correct sites, and maintaining various study trackers as directed by project leadership.
• • Communications support involves sending study-related updates to sites and investigators, including SUSARs, email blasts, newsletters, and other required information, as directed by the Project Manager or Clinical Trial Manager.
• • The specialist may support the distribution and tracking of IND Safety Reports/SUSARS/CIOMS under safety staff guidance, assist with translation of site-level documents per local standards, and act as a point of contact for project-related requests from team members, sponsors, and third-party vendors.
• • Additional duties include supporting the preparation, distribution, and reconciliation of study materials (e.g., Operations Manual, ISF, patient cards), assisting with the production of study reports (e.g., initiation, activation, recruitment updates), and performing other tasks as assigned by project leadership.
• • The team operates within Precision Medicine Group’s integrated precision medicine CRO model, combining innovative trial design, medical expertise, biomarker analytics, and a deep commitment to rare diseases and oncology to deliver actionable insights that accelerate therapeutic development.
• • The company fosters a mission-driven culture where employees contribute to transforming cancer treatment through molecular-level targeting, biomarker-driven therapies, and adaptive trial designs, offering the specialist meaningful impact in advancing oncology development pathways.
• • In this role, the individual will develop deep expertise in clinical trial operations, regulatory frameworks (ICH-GCP), and project management tools within a global, fast-growing precision medicine environment.
• • They will gain hands-on experience with CTMS, document management systems, training platforms, and cross-functional collaboration, building a strong foundation for advancement into roles such as Clinical Trial Assistant, Project Coordinator, or Clinical Trial Manager.
• • The position offers the opportunity to refine organizational, communication, and detail-oriented skills in a high-stakes, regulated industry, while working remotely from Poland with a diverse, international team dedicated to scientific excellence and patient impact.