Clinical Trial Coordinator FSP (mfd)

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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 services mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between its 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 organizations 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 reprioritize workload to meet changing project timelines

• Proven ability to attain and maintain a good working knowledge of applicable Country Regulations ICH Good Clinical Practices and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation execution and closeout

• Excellent English and German (C1 level) languages

• Advanced digital literacy proficient in MS Office (Word Excel and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems

• Ability to successfully complete PPD clinical training program

• Self-motivated positive attitude and good interpersonal skills

At PPD clinical research services we hire the best develop ourselves and each other and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme ensuring you reach your potential.

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 have a flexible working culture where PPD clinical research services truly value a work-life balance. Weve 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 4i Values:

Integrity Innovation Intensity Involvement

If you resonate with our 4i values above and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the worlds most urgent health needs submit your application - wed love to hear from you!

Severely disabled applicants with the same aptitude will be given preferential treatment.
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