Clinical Trial Coordinator Job at PPD, Part of Thermo Fisher Scientific | Apply Now

PPD, part of Thermo Fisher Scientific, is hiring a Clinical Trial Coordinator – FSP (m/f/d) in Karlsruhe, Germany. This PPD clinical trial coordinator job is full time and permanent. The role is full time and permanent. A university degree in life sciences, or equivalent in education, training and experience, is listed as required.

  • Position: Clinical Trial Coordinator – FSP (m/f/d)
  • Location: Karlsruhe, Germany
  • Job ID: R-01350629
  • Category: Clinical Research

About PPD

Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).

PPD clinical trial coordinator 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.

Eligibility Criteria

  • University degree in life sciences, or equivalent in education, training and experience

Required Skills

  • 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

PPD clinical trial coordinator – Key Responsibilities

  • 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.

This PPD Clinical Trial Coordinator Job in Germany offers an opportunity to build a career in clinical research and support the successful execution of clinical trials. Candidates with a life sciences degree, strong organizational skills, and excellent German and English language proficiency (C1 level) can review the eligibility criteria and apply through the official job notification.

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