Clinical Trial Coordinator
Permanent, full time
Onsite or hybrid - Munich or Karlsruhe
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.
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 in the organization's WPD and department guidance document. You will support training of new staff and participate in departmental initiatives to support process improvements/enhancements.
Essential Functions:
- Coordinates, oversees and completes functions on assigned trials activities.
- 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 and line manager as appropriate.
- Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.
- Supports scheduling of client and/or internal meetings with completion of related meeting minutes.
- Reviews and tracks local regulatory documents.
- Transmits documents to client and centralized IRB/IEC.
- 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.
- May attend Kick off meeting and take notes when required.
Education and Experience:
- Bachelor’s degree in a life science related field or a registered nursing certification or equivalent and relevant formal academic/vocational qualification
- Solid organizational skills and strong attention to detail, with demonstrated ability to handle multiple tasks efficiently and effectively
- Strong customer focus
- Fluent written and spoken German (C1 level), and English language
- Strong computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
What We Offer: As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We havea flexible working culture, where PPD CRG truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
