The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the execution of early clinical trials. Joining our team offers the opportunity to work on innovative projects in a dynamic environment. You will support trial preparation, documentation, and coordination, ensuring compliance with regulatory standards and internal processes. This role combines operational and administrative responsibilities and requires close collaboration with internal and external stakeholders.
We currently offer an exciting opportunity to join the FSP team as global Clinical Trial Coordinator ECT (m/w/d) in full-time and work home-based throughout Germany.
RESPONSIBILITIES
- Coordinate clinical trials in early clinical development for both Sponsor and Study site.
- Support Clinical Trial Leaders, Clinical Trial Managers, Clinical Research Associates and Principal Investigators in all study-related activities throughout all study phases (preparation, conduct, close-out).
- Prepare and manage clinical trial documentation
- Compilation and collection of submission documents.
- Maintain trial-specific data and timelines in electronic systems.
- Communicate effectively with internal and external partners (e.g., statisticians, data managers, regulatory affairs, investigators).
- Organize and monitor study-related activities, meetings, and documentation.
- Ensure timely preparation of submission documents for authorities and ethics committees.
- Manage essential documents for Investigator Site File (ISF) and ensure Trial Master File (TMF) completeness and compliance.
- Act as TMF Records Specialist: oversee TMF strategy, perform quality checks, maintain List of Expected Records, and ensure audit/inspection readiness.
- Participate in process harmonization initiatives and support implementation of new systems.
- Assist in finalizing Clinical Trial Reports (CTR) and appendices.
REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE
- Bachelor’s or higher-level degree in Business Administration, Life Science or equivalent, with experience in clinical trials.
- Alternatively, vocational training with extensive experience in clinical and regulatory environments.
- At least 5 years’ experience as Clinical Trial Coordinator or within a similar role in clinical research.
- Strong knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Excellent administrative and organizational skills.
- Strong communication and interpersonal skills.
- Proficiency in MS Office and eTMF systems (e.g., Veeva, BIRDS).
- Fluent languages skills in German on at least C1 level and good command of English.
- Ability to work independently, prioritize tasks, and manage multiple projects in a complex international environment.
WHAT YOU CAN EXPECT
- Permanent employment contract.
- In-depth training and mentoring.
- Home-Office throughout Germany.
- Competitive salary and benefits package.
We invite you to join IQVIA!
Please apply with your English CV, motivation letter and education certificates and job reference letter.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
