Clinical Study Associate Manager (CSAM) - UK in Cambridge

The Clinical Study Associate Manager (CSAM) Service supports the Clinical Study Lead by taking responsibility for areas of clinical trial delivery. The Clinical Study Associate Manager works with the study team internally and externally with vendors such as CROs in feasibility, planning, initiation, maintenance and closeout of clinical projects according to GCP, ICH, CFR and our Client’s Standard Operating Procedures (SOPs) and ICH/GCP. This Service applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs); the balance of direct execution versus oversight of CROs deliverables will vary accordingly.

CSAM Duties

• May lead/oversee the planning and management of a clinical study in an assigned region(s) in alignment with the global study plans and may contribute to global planning and management of the study.
• Contributes to risk assessment and helps identify risk mitigation strategies.
• Supports feasibility assessment to select relevant regions and countries.
• Oversees and provides input to the development of study specific documentation including but not limited to: case report form (CRF), data management plan, monitoring plan, monitoring oversight plan, etc.
• Reviews site level informed consents and other patient-facing study start-up materials.
• Oversees setting up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF).
• Contributes to investigator meeting preparation and execution.
• Oversees engagement, contracting and management of required vendors for the study.
• Oversees and provides input to study drug and clinical supplies forecasting, drug accountability and drug reconciliation.
• Provides regular status reports to stakeholders as requested by the Clinical Study Lead.
• Contributes to development of and oversees implementation of recruitment and retention strategies.
• Monitors progress for site activation and monitoring visits.
• Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites.
• Escalates data flow and data quality issues to Clinical Study Lead.
• Oversees the execution of the specific clinical study deliverables against planned timelines.
• Escalates issues related to timelines or budget to Clinical Study Lead.
• Supports accurate budget management and scope changes.
• Contributes to clinical project audit and inspection readiness throughout the study lifecycle.
• Supports internal and external inspection activities and contributes to CAPAs as required.
• Manages aspects of study close-out activities including but not limited to database lock, reconciliation of vendor contract, study budget, TMF and study drug accountability.
• May be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring.

CSAM Requirements

• Bachelor’s degree and minimum 4 years of relevant experience.
• Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, EDC, IWRS/IVRS.
• Knowledge of ICH GCP and relevant regulatory guidelines/directives.
• Demonstrated interpersonal & leadership skills.
• Attention to details for the ability to deliver on specific study activities.
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritisation.
• Budget awareness with the ability to participate in various aspects of budget management.
• Effective communication skills via verbal, written and presentation abilities.