7+ years of clinical trial management experience in pharmaceuticals or biotechnology.
2+ years of indirect or matrixed team leadership experience.
Proven track record managing complex global clinical studies.
Expertise in overseeing global CROs and specialty vendors.
Strong understanding of drug development lifecycle and ICH-GCP guidelines.
Experience in site feasibility, study startup, and investigator relationships.
Ability to interpret operational metrics and develop solutions.
Responsibilities
Lead operational planning and execution of global clinical trials.
Serve as a key clinical operations leader for study performance and milestones.
Drive site feasibility, investigator identification, and patient enrollment activities.
Partner with clinical teams to manage timelines and operational dependencies.
Oversee CROs and service providers, ensuring quality and performance.
Develop clinical trial management plans and executive-level updates.
Implement proactive risk management and quality oversight practices.
Benefits
Long-term contract anticipated through October 2028.
Full-time schedule of 40 hours per week.
Opportunity to lead complex global clinical studies.
Exposure to cross-functional clinical development teams and global CROs.
Chance to influence clinical trial delivery and operational quality.
Full Job Description
Job Description What's In Store For You
Location: Bridgewater, NJ. Work arrangement to be confirmed.
Engagement: W2 only (no C2C/1099).
Contract: Long-term assignment anticipated through October 2028.
Schedule: Full-time, 40 hours per week.
Opportunity to lead complex, global clinical studies within an innovative biopharmaceutical environment.
Exposure to cross-functional clinical development teams, global CROs, and specialized research vendors.
Opportunity to influence clinical trial delivery, operational quality, investigator engagement, and patient enrollment strategies.
How You Will Make An Impact
Lead the operational planning, coordination, and execution of complex global clinical trials, ensuring alignment with study objectives, regulatory requirements, timelines, and budgets.
Serve as a key clinical operations leader, with potential accountability for overall study performance, regional trial execution, and critical operational milestones.
Drive site feasibility, investigator identification, site selection, activation, and patient enrollment activities to support clinical development objectives.
Partner with cross-functional clinical teams to establish study timelines, manage operational dependencies, identify emerging risks, and implement corrective action plans.
Oversee CROs and specialized service providers throughout the study lifecycle, monitoring contractual commitments, operational performance, quality, and milestone achievement.
Develop and maintain clinical trial management plans, operational documentation, study reports, and executive-level progress updates.
Contribute to the development and review of clinical protocols, amendments, informed consent forms, case report forms, regulatory submissions, and investigator-facing materials.
Implement proactive risk management and quality oversight practices, including risk-based quality management and applicable monitoring strategies.
Collaborate with Clinical Development, Clinical Science, and Data Management to support ongoing data review, issue resolution, and timely database lock.
Maintain inspection readiness by ensuring clinical trial documentation, Trial Master File completeness, and compliance with applicable GCP and regulatory standards.
Facilitate productive relationships with investigators, research sites, CRO partners, and internal stakeholders to resolve challenges and maintain trial momentum.
Provide guidance, coaching, and operational leadership to matrixed study team members while promoting accountability and effective communication.
Requirements Do You Bring Proven Success In Global Clinical Trial Leadership And CRO Management?
7+ years of clinical trial management experience within the pharmaceutical or biotechnology industry, with demonstrated responsibility for clinical trial execution and operational delivery.
2+ years of experience providing indirect or matrixed team leadership, including coaching, mentoring, and influencing cross-functional contributors.
Proven experience managing complex global clinical studies, including large-scale and/or early-phase development programs.
Demonstrated expertise overseeing global CROs, specialty vendors, and outsourced clinical trial services.
Strong understanding of the drug development lifecycle, clinical operations processes, ICH-GCP guidelines, and applicable regional regulatory requirements.
Experience managing site feasibility, study startup, site activation, enrollment performance, and investigator relationships.
Working knowledge of clinical trial quality oversight, risk management, protocol compliance, inspection readiness, and Trial Master File requirements.
Ability to interpret operational metrics, identify performance gaps, and develop practical solutions to complex clinical trial challenges.
Strong project management capabilities, including timeline development, resource coordination, budget awareness, and milestone tracking.
Experience collaborating with multidisciplinary clinical development teams in a global, matrixed organization.
Excellent written and verbal communication skills, with the ability to influence stakeholders, manage conflict, and communicate effectively with senior leadership.
Demonstrated independence, sound judgment, proactive problem-solving, and the ability to manage competing priorities.
Experience supporting rare disease and/or orphan drug clinical programs is highly desirable.
Bachelor's degree in life sciences, healthcare, or a related discipline is preferred.
