Clinical Trial Coordinator - FSP (m/f/d)

Thermo Fisher ScientificKarlsruhe, GermanyonsiteSalary not postedView the original posting at Thermo Fisher Scientific ↗

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Through our PPD® clinical research services, we support clinical trials in more than 100 countries, delivering laboratory, digital and decentralized solutions that help bring life-changing therapies to patients faster. Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations. Why Join PPD, part of Thermo Fisher Scientific? Work on high-quality, global clinical trials across diverse therapeutic areas Be part of a stable, well-established organization with long-term career opportunities Strong collaboration with experienced CTMs and project teams Clear development pathways (e.g., Senior CRA, Lead CRA, CTM) Flexible working models that support work-life balance Permanent employment Full-time (40 hours/week) Discover Impactful Work: PPD clinical research service`s mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our dedicated, forward-thinking and upbeat teams. Position Overview: As a Clinical Trial Coordinator, you will provide administrative and technical support to the Project Team. You will support audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document. Essential Functions: According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix. Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system. Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads. Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system. Provides system support (i.e. GoBalto & eTMF). Supports RBM activities. Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members. Supports scheduling of client and/or internal meetings. Reviews and tracks local regulatory documents. Transmits documents to client and centralized IRB/IEC. Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation. Maintains vendor trackers. Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites. Assists with study-specific translation materials and translation QC upon request. Keys to Success: Education: University degree in life sciences, or equivalent in education, training and experience Knowledge, Skills, Abilities: Ability to work in a team or independently as required Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency Strong customer focus Flexibility to repriori

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