About The Role

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

We 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.