Project Support Specialist

Precision Medicine Group

Job Overview

Location

Remote, Hungary

Job Type

Full-time

Full Job Description

📋 Description

• The Project Support Specialist plays a critical role in enabling the efficient execution of clinical trials within Precision Medicine Group’s precision medicine CRO, directly contributing to the advancement of oncology and rare disease research by ensuring seamless operational support across study lifecycles.
• This role is ideal for detail-oriented professionals seeking to build expertise in clinical trial operations while supporting mission-critical work that accelerates life-saving therapies from lab to patient.
• 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.
• The specialist schedules internal and external meetings, prepares and circulates agendas, takes and files meeting minutes in the Trial Master File, and ensures all documentation is properly archived for regulatory compliance.
• They perform key activities in the Clinical Trial Management System (CTMS), including updating study milestone dates, managing contact lists, tracking enrolment projections, and submitting and following up on helpdesk tickets to ensure system integrity.
• The role involves preparing, assigning, and documenting study-specific training, maintaining training records, identifying gaps, and coordinating remediation with appropriate team members or escalating as needed.
• The specialist establishes and manages study-level SharePoint sites or similar shared workspaces, ensuring appropriate access for internal teams, sponsors, and vendors while maintaining data security and version control.
• They create and manage project-specific email boxes, oversee user access to study systems by submitting access requests, conducting periodic reviews, and documenting outcomes to uphold compliance and security protocols.
• Additional duties include ordering study supplies and initial study binders, coordinating with printing vendors for collation and shipping, and maintaining various study trackers as directed by project leadership.
• The specialist sends communications to study sites and investigators, including SUSARs, email blasts, and newsletters, as directed by the Project Manager or Clinical Trial Manager, supporting timely information dissemination.
• They may assist in the distribution and tracking of IND Safety Reports/SUSARS/CIOMS under safety staff guidance and support translation processes for site-level documents per local and regional standards.
• Acting as a point of contact for project-related requests from team members, sponsors, and third-party vendors, the specialist ensures timely responses and facilitates cross-functional coordination.
• They support the preparation, distribution, and reconciliation of study materials such as Operations Manuals, ISFs, and patient cards during applicable study phases, ensuring accuracy and completeness.
• The role includes assisting team leaders with generating study reports and updates on country/site initiation, activation, and recruitment metrics, contributing to trial performance visibility.
• The Project Support Specialist performs other duties as assigned by project leadership, demonstrating adaptability and a proactive approach to evolving study needs.
• The team operates within a passionate, science-driven organization committed to precision medicine, where innovation in trial design, biomarker analytics, and rare disease oncology converges to improve patient outcomes.
• Working in this role offers the opportunity to develop deep expertise in clinical trial operations, regulatory compliance (ICH-GCP), and cross-functional project management within a global CRO environment.
• The specialist gains hands-on experience with industry-standard tools like MS Project, CTMS, and SharePoint, while building proficiency in documentation, communication, and process adherence essential for career growth in clinical research.
• This position fosters professional development in stakeholder engagement, attention to detail, and independent problem-solving—skills highly transferable across healthcare, life sciences, and project management domains.

🎯 Requirements

• 4-year college degree or equivalent experience in a business, scientific, or healthcare discipline
• Minimum of 2 years of relevant experience as a Clinical Trial Assistant, Clinical Support Specialist, or similar role in clinical research
• Fluency in Microsoft Office (Outlook, Word, Excel, PowerPoint) and working knowledge of ICH-GCP, Precision SOPs, and regulatory guidance
• Professional-level English proficiency in both written and verbal communication, with strong interpersonal and customer service skills
• Demonstrated self-motivation, detail orientation, and ability to work independently and collaboratively in a team environment
• Commitment to upholding Precision Medicine Group’s Precision Principles and maintaining confidentiality and compliance standards

🏖️ Benefits

• Fully remote work opportunity based in Hungary, Poland, Serbia, Slovakia, or Romania, offering flexibility and work-life balance
• Employment with a mission-driven precision medicine CRO dedicated to advancing oncology and rare disease therapies through innovative clinical trial design
• Access to professional development opportunities in clinical trial operations, regulatory compliance, and project management within a growing global organization
• Collaborative, inclusive culture that values diversity, equity, and equal opportunity employment regardless of background or identity
• Exposure to cutting-edge biomarker and data analytics solutions, and the chance to contribute to real-world impact in cancer and rare disease research
• Comprehensive onboarding and ongoing support from experienced project leaders and cross-functional teams

Skills & Technologies

GCP

Remote

Degree Required

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Precision Medicine Group

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About Precision Medicine Group

Precision Medicine Group (PMG) is a leading life sciences consulting firm dedicated to accelerating the development and commercialization of precision medicine. They offer a comprehensive suite of services, including strategy, market access, regulatory affairs, and commercialization support. PMG partners with pharmaceutical, biotechnology, and diagnostic companies to navigate the complex landscape of personalized healthcare. Their expertise spans various therapeutic areas and advanced molecular technologies. By leveraging deep scientific knowledge and market insights, PMG helps clients optimize their drug development pipelines, secure regulatory approvals, and successfully launch innovative therapies. They are committed to advancing patient care through the power of precision medicine, ensuring that the right treatments reach the right patients at the right time.

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