Clinical Trial Associate

Elixir Associates; Berlin; Vor Ort; EUR 45.000 - 60.000; Vollzeit

Zusammenfassung

A leading European biotech company in Berlin is seeking a Clinical Trial Associate to support the planning and execution of global clinical trials. The role involves maintaining the Trial Master File and ensuring compliance with regulatory standards. Candidates must have 1-3+ years of experience in clinical operations, strong organizational and communication skills, and a detail-oriented mindset. This position offers visibility within an expanding team and the opportunity for professional growth.

Qualifikationen

• 1-3+ years of experience as a CTA or in a similar clinical operations support role.
• Experience with TMF maintenance and quality control.
• Familiarity with ICH-GCP guidelines and global clinical trial regulations.

Aufgaben

• Maintain and QC the Trial Master File (TMF) to ensure inspection readiness.
• Support study start-up activities, including collection and tracking of essential documents.
• Assist with vendor oversight and study timelines.

Kenntnisse

Study document management

Organizational skills

Communication skills

Detail-oriented mindset

Jobbeschreibung

Company

Elixir Associates are currently partnering with a rapidly growing European biotech developing next-generation therapies in the critical-care / cardiology space. The company is expanding its Clinical Operations team and seeking a talented Clinical Trial Associate to support their advancing clinical programs across multiple Phase 2 studies.

About The Job

Reporting directly to the Head of Clinical Operations, the Clinical Trial Associate will play a key role in supporting the planning, execution, and oversight of global clinical trials. You will work cross‑functionally with Clinical Operations, Quality, Regulatory, and external partners, ensuring essential documentation, systems, and processes are maintained to inspection‑ready standards.

This is a hands‑on position offering strong visibility within a small, high‑performing team, with the opportunity to develop broadly within Clinical Operations as the pipeline grows.

Required Experience

• 1-3+ years of experience as a CTA or in a similar clinical operations support role (biotech, pharma, or CRO)
• Experience with study document management, including TMF maintenance and QC
• Familiarity with ICH‑GCP guidelines and global clinical trial regulations
• Experience coordinating with CROs and clinical vendors
• Strong organizational skills with the ability to manage multiple activities in a fast‑paced environment
• Excellent communication skills and a proactive, detail‑oriented mindset

Key Responsibilities

• Maintain and QC the Trial Master File (TMF) to ensure inspection readiness
• Support study start‑up activities, including collection and tracking of essential documents
• Assist with vendor oversight, meeting coordination, and study timelines
• Manage study tracking tools, logs, and internal documentation
• Support preparation of study materials (e.g., site manuals, training slides, meeting minutes)
• Contribute to cross‑functional communication to ensure smooth trial execution

If this opportunity is of interest or you would like to find out more, please apply.

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