Sr Manager Clinical Study Lead, Experimental Sciences

Description

• Identify outsourcing needs and oversee vendor engagement and management.
• Identify innovative approaches to clinical study execution and contribute to global considerations and continuous improvement processes.
• Provide operational input into research plan and study protocol development.
• Communicate learnings, best practices, and relevant information to ensure consistency and alignment across staff.
• Contribute to baseline timeline and budget development and management.
• Oversee the setup and maintenance of study systems such as CTMS, TMF, and SharePoint.
• Participate in cross-functional and departmental process improvement initiatives.
• Ensure timely completion of study-specific documentation like sample management and data management plans.
• Lead the cross-functional study team for clinical study delivery.
• Collaborate with Therapeutic Focus Area groups within Basic Research/Discovery.
• Escalate issues related to study conduct, quality, timelines, or budget to stakeholders and implement solutions.
• Manage study close-out activities and ensure proper archiving of the End of Study Summary.
• Facilitate study-level lessons learned and assign tasks to Clinical Study Management staff.
• Ensure accurate budget management and address scope changes for studies.
• Ensure alignment and delivery by CROs and Third Party Vendors as per scope of work.
• Work closely with clinical site staff, predominantly at academic institutions.

Requirements

• Strong understanding of trial science and effective communication with scientists.
• Experience in clinical experimental sciences with small trials and populations.
• Experience in budget management, including building study budgets from scratch.
• Proficiency in clinical trial and research management.
• People management skills.
• Ability to work in a dynamic, changing environment.
• Bachelor’s degree required.
• Minimum 8 years of relevant clinical trial experience in investigational studies and early-phase trials.

Benefits

• Employee Assistance Program
• Medical, dental & vision
• Transportation benefits
• Health Spending Account (HSA)
• Short and long-term disability
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Critical Illness, Accident, and Hospital
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Warren,NJ. Application Deadline This position is anticipated to close on Dec 26, 2025.
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Training + Development

Interview process

Visa Sponsorship

Security clearance