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Clinical Study Manager
vor 3 Monaten
Position Overview
The Clinical Project Manager will be responsible for overseeing the planning and execution of multicenter clinical trials aimed at evaluating new pharmaceuticals and in vitro diagnostic tools across various regions, including the EU and beyond.
Key Responsibilities
- Manage and coordinate multicenter clinical studies to assess innovative treatments and diagnostics.
- Collaborate with prominent national and international partners, engaging with clinical research facilities globally, particularly in Sub-Saharan Africa.
- Develop essential study documentation such as protocols, case report forms (CRFs), and informed consent forms in partnership with project scientists, statisticians, and data management teams.
- Identify and contract research organizations (CROs) and central laboratories for study execution.
- Ensure timely and accurate submission of projects to ethics committees and regulatory authorities in the capacity of a study sponsor.
- Provide training and on-site support to study centers, conducting joint monitoring visits with CROs.
- Oversee study progress and data integrity, providing updates to external funding bodies.
- Implement and uphold quality assurance protocols throughout the study lifecycle.
Qualifications
- Proven experience in managing GCP-compliant clinical trials.
- In-depth understanding of ICH-GCP, EMA, and FDA regulations.
- Educational background in natural sciences, medicine, pharmacy, or medical documentation.
- Fluent in English, with excellent communication skills.
- Willingness to travel as required.
- Strong conceptual and structural thinking abilities, with a focus on results.
- Exceptional organizational, communication, and teamwork capabilities.
What We Offer
- An opportunity to play a key role in the successful implementation of a new clinical trials project.
- A stimulating work environment within a dynamic team, with the chance to contribute significantly to the advancement of new therapeutic solutions.
- Competitive salary aligned with public service employee agreements.
- Initial contract duration of two years, with potential for extension based on project needs.
