Senior Manager Clinical Study Lead (Oncology)

Regeneron Pharmaceuticals, Inc; Cambridge; On-site; GBP 70,000 - 90,000; Full time

Job summary

A global biopharmaceutical company based in Cambridge is seeking a Senior Manager Clinical Study Lead to oversee the execution of complex clinical trials. This role requires leadership of cross-functional teams, management of budgets and timelines, and ensures compliance with regulatory guidelines. Applicants should have a Bachelor's degree and at least 8 years of relevant clinical trial experience. This position offers opportunities for professional development and is not available for remote work.

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.
• Extensive experience in global clinical trial operations and protocol development.
• Knowledge of ICH/GCP and regulatory guidelines.
• Advanced project management and organizational skills.

Responsibilities

• Lead the cross-functional study team for clinical study delivery.
• Oversee study-specific documentation and study systems.
• Manage vendor engagement and contracting.
• Contribute to budget and timeline development.
• Conduct feasibility assessments and oversee site evaluation.
• Monitor study execution against timelines and budgets.
• Support audit and inspection readiness.

Skills

Interpersonal skills

Leadership skills

Operational strategy expertise

Data-driven planning

Problem-solving skills

Communication skills

Negotiation skills

Stakeholder management

Knowledge of trial management systems

Project management skills

Education

Bachelor's degree

Tools

MS Office applications

Job description

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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.