Senior Clinical Study Lead - Contract - Basking Ridge, NJ
Take the lead in delivering global clinical studies-shaping strategy, driving execution, and making a real impact.
A leading global biotechnology organisation is seeking a Senior Clinical Study Lead to join its Clinical Trial Management team, supporting innovative programs within immunology and related therapeutic areas.
This is a high-impact role responsible for the end-to-end global execution of large and complex clinical trials, from study design through to close-out.
This role offers a hybrid working model (4 days on-site in New Jersey) with approximately 25% travel required.
Primary Responsibilities:
The successful candidate will operate with a high degree of autonomy, ensuring studies are delivered on time, within budget, and in compliance with regulatory standards and internal procedures.
Skills & Requirements:
- Bachelor's degree (or higher) in a relevant scientific discipline
- Extensive experience in global clinical trial operations, including large and/or complex studies
- Proven leadership and line management experience
- Strong knowledge of ICH-GCP and regulatory requirements
- Demonstrated ability to manage budgets, timelines, and vendors
- Advanced proficiency in clinical systems (e.g., CTMS, EDC, IVRS/IWRS) and MS Office tools
- Strong stakeholder management, communication, and negotiation skills
- Ability to operate independently, prioritize effectively, and manage competing deadlines
- Experience in protocol development, risk management, and patient recruitment strategies
The Senior Clinical Study Lead's responsibilities will be:
- Lead cross-functional study teams and act as the primary point of contact for study delivery and oversight
- Drive global clinical trial execution, ensuring adherence to timelines, budgets, and quality standards
- Oversee development of key study documentation (e.g., CRFs, data management plans, monitoring plans, SAPs)
- Manage and maintain clinical trial systems such as CTMS and TMF
- Identify outsourcing needs and oversee vendor selection, contracting, and performance management
- Contribute to budget planning and timeline development across the study lifecycle
- Conduct risk assessments and implement mitigation strategies
- Lead feasibility assessments and support country/site selection
- Monitor study progress including site activation, recruitment, data quality, and metrics performance
- Oversee clinical supply planning, drug accountability, and reconciliation
- Escalate study risks and issues, ensuring timely resolution and stakeholder alignment
- Lead study close-out activities including database lock, vendor reconciliation, and TMF completion
- Support unblinded study activities where applicable
- Provide line management, coaching, and development for Clinical Trial Management staff
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at b.forsen@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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