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Associate at Mantell Associates - Clinical Research - Contract
Mantell Associates is partnered with an innovative and rapidly advancing biotech company, who is seeking a proactive and seasoned Senior Clinical Research Associate to support the execution of complex clinical trials across the EU.
This role is essential in ensuring excellence in clinical monitoring, patient safety, and regulatory compliance.
Responsibilities
- Lead site monitoring activities across studies to ensure compliance with study protocols, ICH-GCP, and applicable EU/regional regulations
- Oversee site initiation, training, routine and follow-up visits, and site close-out, ensuring high-quality delivery aligned with clinical timelines and milestones
- Manage source data verification (SDV), resolve queries, and oversee case report form (CRF) accuracy in collaboration with sites and CRAs
- Facilitate clear communication with clinical operations, data management, safety, and regulatory teams to address site or trial issues effectively
- Support investigator training, site compliance audits, and ensure site readiness for inspections
- Track and report site performance metrics, patient enrollment status, and deliver updates to project teams and stakeholders
Requirements
- 3-5 years of clinical monitoring experience (CRA or Senior CRA level) at biotech or pharmaceutical companies or CROs within the EU
- Deep understanding of ICH-GCP guidelines, the EU Clinical Trial Regulation (EU CTR), and other regional regulatory frameworks
- Degree in Life Sciences, Pharmacy, Nursing, or a related field - advanced degrees advantageous
- Proven ability to manage multiple high-performing sites, deliver oversight, and mentor junior CRAs
- Fluent in English; proficiency in additional European languages (e.g., German, French, Spanish) is a strong asset
- EU-based and willing to travel within the region to support trial needs
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.
Seniority level
Employment type
Job function
- Research, Science, and Legal
Industries
- Biotechnology Research, Pharmaceutical Manufacturing, and Chemical Manufacturing