Clinical Study Associate Manager (CSAM)

51229
  • London, United Kingdom
  • Contract
🔹 Clinical Study Associate Manager (CSAM)
📍 Uxbridge (3 days onsite required)
We are currently partnering with a global life sciences organisation to hire a Clinical Study Associate Manager (CSAM) to support the delivery of international clinical trials.
This is an excellent opportunity for a Clinical Operations professional with 4+ years of experience who is looking to take on broader responsibility across the full study lifecycle, working closely with a Clinical Study Lead and cross-functional teams.

🔹 The Role
In this position, you will play a key role in the coordination and execution of clinical studies, contributing to activities from study start-up through to close-out. You will collaborate with internal stakeholders and external partners, including CROs and vendors, ensuring studies are delivered in line with regulatory requirements, timelines, and quality standards.
The role offers a mix of hands-on study delivery and oversight of outsourced activities, depending on the study model.

🔹 Key Responsibilities
  • Support regional and global study planning and execution in alignment with overall clinical strategy
  • Contribute to study feasibility and country/site selection activities
  • Assist in identifying study risks and implementing mitigation strategies
  • Review and contribute to key study documentation (e.g. monitoring plans, data management plans, CRFs)
  • Provide oversight of study systems including CTMS and TMF to ensure inspection readiness
  • Coordinate vendor and CRO activities, including selection, contracting, and ongoing performance management
  • Support clinical supply planning, forecasting, and reconciliation processes
  • Track study progress including site activation, patient recruitment, and monitoring activities
  • Analyse study data outputs to identify trends, deviations, and potential compliance issues
  • Escalate risks related to timelines, quality, or budget where appropriate
  • Contribute to budget tracking and management of scope changes
  • Support audit and inspection readiness activities, including CAPA follow-up
  • Assist with study close-out activities such as database lock, vendor reconciliation, and documentation finalisation
  • Participate in investigator meeting planning and delivery

🔹 About You
  • Bachelor’s degree in a life sciences or related field
  • Minimum 4 years’ experience within Clinical Operations or clinical research
  • Strong understanding of ICH-GCP and relevant regulatory frameworks
  • Experience working with clinical systems (e.g. CTMS, EDC, IWRS/IVRS)
  • Proven ability to work cross-functionally and manage external partners
  • Strong organisational skills with the ability to manage multiple priorities
  • High attention to detail and a proactive approach to problem-solving
  • Confident communicator with experience engaging a range of stakeholders
  • Exposure to budget tracking or financial oversight within clinical studies is advantageous

🔹 Additional Information
  • Hybrid working model: 3 days per week onsite in Uxbridge (essential)
  • Opportunity to work on global studies within a collaborative and fast-paced environment
  • Strong potential for career development within Clinical Operations

If you’re interested in learning more, feel free to get in touch for a confidential discussion.

Please send CV to CBurton@barringtonjames.com 

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