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Team Lead Clinical Research Coordinator
Job ID R0000045053 Berlin, Land Berlin, GermanyWe are seeking a dedicated Lead Clinical Research Coordinator (LCRC) to join our Early Phase Clinical Trial Unit in Berlin.
The LCRC is accountable for the planning, preparation, and execution of clinical trials in collaboration with the Team Leader, Project Manager, and Investigator.
This role ensures that clinical studies are conducted according to the study protocol, ICH GCP guidelines, and unit SOPs.
You will assist in the conduct of studies across all therapeutic areas, ensuring studies are prepared to the highest standard within specified timelines. The role also involves clinical conduct oversight, data cleaning, and deviations management.
You may be responsible to line-manage a team of Clinical Research Coordinators (CRCs) with all associated responsibilities (performance reviews, PTO management etc.)
Key accountabilities:
- Study Leadership & Oversight – Technically supervise clinical research staff and direct all operational aspects of assigned early-phase studies from preparation through completion
- Study Preparation & Protocol Implementation – Review study protocols and documentation for feasibility; develop risk management plans; establish study procedures, training programs, and volunteer care protocols in compliance with GCP/ICH guidelines
- ClinBase & Systems Management – Lead ClinBase setup across all departments; review data validation requirements, annotated CRFs, and user-defined procedures; approve systems for clinical use
- Quality & Compliance – Manage protocol deviations, quality issues, and audit findings; ensure all study activities and documentation meet protocol and regulatory requirements
- Clinical Operations – Coordinate ward preparation, volunteer care from admission to discharge, medication management, and physiological assessments (ECG, blood pressure, venous puncture, etc.)
- Monitor Coordination & Data Management – Prepare for monitor visits; resolve data clarification queries; manage CRF shipment and archiving
- Stakeholder Engagement – Collaborate with study physicians, project managers, data management, and internal departments; participate in project and client meetings
- Team Leadership (if applicable) – Line-manage a team of 4-9 Clinical Research Coordinators, including performance management, development, and disciplinary oversight.
Skills:
- Intermediate English knowledge (written and spoken command)
- Computer skills (Windows Office)
- Organizational talent
- Ability to work under pressure and flexibility in working times
- Ability to work on weekends and holidays
- Knowledge of ICH-GCP Guidelines.
Knowledge and Experience:
- Relevant experience in hospitals or medical surgery
- Proven experience as a Clinical Research Coordinator.
Education:
- Qualified as nurse, MTA, doctor´s assistant, paramedic, or similar/equivalent qualification/education.
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