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.
杨贵妃传媒网ygfcmw·(中国)站入口直接进 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 杨贵妃传媒网ygfcmw·(中国)站入口直接进 is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - /privacy-policy
