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Senior Manager Clinical Study Lead (Oncology), Cambridge
Client:
Location:
Cambridge, United Kingdom
Job Category:
Other
EU work permit required: Yes
Job Reference: f1ca81b2d20b
Job Views: 6
Posted: 12.08.2025
Expiry Date: 26.09.2025
Job Description:
This role is an onsite position in one of our office locations. Fully remote is not eligible.
The Senior Clinical Study Lead (CSL) is expected to operate with a high degree of independence and is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close-out. The Senior CSL is accountable for study timelines, study budget, and ensuring study conduct is in accordance with Regeneron SOPs and ICH/GCP. This role applies to internally sourced studies and studies outsourced to CROs, with the balance of leadership versus oversight varying accordingly. Contributes to and drives ongoing process improvement initiatives.
A typical day in this role includes:
* Leading the cross-functional study team responsible for clinical study delivery and serving as the primary contact for leadership and oversight
* Overseeing and providing input to study-specific documentation such as CRFs, data management plans, monitoring plans, training plans, data review plans, and statistical analysis plans
* Managing setup and maintenance of study systems including CTMS and TMF
* Ensuring compliance with clinical trial registry requirements
* Identifying outsourcing needs and managing vendor engagement and contracting
* Contributing to budget and timeline development and management
* Leading risk assessments and mitigation strategies
* Conducting feasibility assessments for region and country selection
* Overseeing site evaluation and selection, investigator meetings, and site activation
* Monitoring progress, data entry, query resolution, and deviations from plan
* Managing patient recruitment and retention strategies
* Overseeing drug and clinical supplies forecasting, accountability, and reconciliation
* Escalating issues related to study conduct, quality, timelines, or budget, and developing appropriate actions
* Ensuring study execution aligns with planned timelines, deliverables, and budgets
* Monitoring data quality and compliance
* Ensuring CRO and vendor alignment and performance
* Supporting audit and inspection readiness, internal audits, and CAPAs
* Managing study close-out activities and contributing to study reports
* Facilitating lessons learned and supporting process improvements
* Supervising CTM staff, including performance management and professional development
This role may include:
* Assisting with masked tasks such as unmasked trial management, data review, and IVRS support
Qualifications:
* Exceptional interpersonal and leadership skills
* Expertise in operational strategy and clinical trial execution
* Strong data-driven planning, problem-solving, and communication skills
* Proactive, disciplined, and deadline-oriented
* Influencing, negotiating, and stakeholder management skills
* Knowledge of industry trends, trial management systems, and MS Office applications
* Extensive experience in global clinical trial operations and protocol development
* Knowledge of ICH/GCP and regulatory guidelines
* Advanced project management and organizational skills
Minimum qualification: Bachelor's degree with at least 8 years of relevant clinical trial experience.
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