Project Support Specialist

🔥 1 minute ago

🌐 Romania, Poland, +3 more countries – Remote

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⏰ Full Time

🟢 Junior

🟡 Mid-level

💝 Customer Support

👻 Ghost score 19%

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Logo of Precision Medicine Group

Precision Medicine Group

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Create and maintain project timelines in MS Project or similar systems, documenting and distributing updates • Schedule internal and external meetings; prepare and circulate agendas and minutes; file records in the Trial Master File • Maintain study milestone dates, contact lists, enrollment projections, and helpdesk tickets in the Clinical Trial Management System • Prepare, assign, document, and oversee study-specific training and training records; identify and escalate training gaps • Establish study-level SharePoint sites or similar shared workspaces and manage access • Create project-specific email boxes and maintain appropriate access • Manage user access to study systems and document periodic access reviews • Order study supplies and respond to supply queries • Order, prepare, collate, and ship initial study binders • Maintain study trackers as directed by project leadership • Send communications to study sites, investigators, sponsors, and other stakeholders, including SUSARs, email blasts, and newsletters • Support distribution and tracking of IND Safety Reports, SUSARs, and CIOMS • Support translation of site-level documents according to local and regional standards • Act as a point of contact for project-related requests from team members, sponsors, and third-party vendors • Support preparation, distribution, and reconciliation of study materials • Support production of study reports and updates, including country/site initiation, activation, and recruitment reports • Perform other duties assigned by 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) • Working knowledge of ICH-GCP, Precision SOPs, and regulatory guidance • Solid interpersonal skills • Strong self-motivation, detail orientation, and ability 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

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