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A specialist CRO is seeking a Senior Clinical Research Associate to support oncology studies in Germany. With a focus on early-phase trials, this role involves managing regulatory documentation, site relationships, and ensuring data integrity. Candidates should have a Bachelor's degree in a life sciences field and at least five years' experience as a CRA.
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A specialist CRO is seeking a Senior Clinical Research Associate (German Contractor) to support oncology studies across Germany on a contract basis. With over four decades dedicated to advancing cancer research, this CRO partners with leading organisations worldwide to deliver early and late-phase oncology trials. Their mission is clear: to give new cancer therapies the strongest chance of improving patient lives, driving progress to make cancer a manageable disease. This is a unique opportunity for experienced professionals who want to contribute meaningfully to oncology development while working with a team that understands both the science and the complexities of bringing therapies to patients.
Your role as Senior Clinical Research Associate
Manage essential regulatory documentation and ensure trial files are always inspection-ready.
Oversee site start-up activities, from preparing investigator and sponsor files to ensuring contracts and budgets align with study timelines.
Build and maintain strong relationships with study sites, providing updates, addressing questions, and supporting sites throughout the trial lifecycle.
Conduct pre-study, initiation, monitoring (both onsite and remote), and close-out visits according to best practices and protocols.
Actively track study progress using CTMS and other systems, ensuring data integrity and timely resolution of site or data issues.
Collaborate closely with project teams, contributing to study reports and proactively addressing potential challenges to keep studies on course.
Experience and qualifications for the Senior Clinical Research Associate role
Bachelor's degree (or equivalent) in a life sciences or health-related field.
A minimum of 5 years' experience as a Clinical Research Associate, ideally with a background in early phase oncology trials.
Deep understanding of ICH-GCP guidelines and local regulatory frameworks.
Strong organisational skills, with the ability to manage multiple studies simultaneously and prioritise effectively.
Excellent interpersonal and communication skills in both German and English, capable of building trust with sites and stakeholders.
Proficiency in Microsoft Office tools (Word, Excel, Outlook) and familiar with CTMS and eTMF systems.
For immediate consideration for this Senior Clinical Research Associate (German Contractor) role, or to discuss similar freelance opportunities in clinical research, please apply today or reach out directly.
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