Senior Clinical Project Manager

7 days ago

Trenton, United States Atrium Staffing Full time

Our client, a mid-sized, clinical-stage biopharmaceutical company specializing in innovative therapies for liver-related disorders and rare diseases, is expanding their Clinical Operations team by hiring a Senior Clinical Project Manager (Clinical Trials). Backed by a global life sciences network and powered by more than 1,000 researchers, this organization focuses on advancing transformative treatments in high-need therapeutic areas. This role offers the chance to be part of a mission-driven organization developing next-generation therapies. This role is ideal for someone with hands-on trial experience looking to lead in a dynamic and collaborative environment.Salary/Hourly Rate:$120k - $140kPosition Overview:The Senior Clinical Project Manager (Clinical Trials) will be responsible for leading the planning, execution, and completion of Phase I-IV clinical trials across multiple therapeutic areas. This position reports directly to the VP of Clinical Project Management and will serve as a key liaison among internal departments, investigators, CROs, and regulatory bodies. The Senior Clinical Project Manager (Clinical Trials) ensures that clinical programs remain compliant, within scope, and aligned with company milestones and regulatory requirements.Responsibilities of the Senior Clinical Project Manager (Clinical Trials):Lead full-cycle clinical trial management from startup to closeout.Develop and maintain project plans, timelines, and trial budgets.Oversee CRO selection, contract negotiation, and vendor performance.Serve as the primary point of contact for internal teams and external stakeholders.Manage risk assessments, protocol deviations, and site-level issues.Ensure adherence to regulatory compliance and GCP/ICH standards.Support the development of SOPs and clinical systems infrastructure.Provide updates to senior leadership and contribute to strategic clinical planning.Mentor junior staff, including CRAs and project coordinators.Required Experience/Skills for the Senior Clinical Project Manager (Clinical Trials):Minimum 5 years of experience in clinical trial management (pharma, biotech, or CRO environment).Proven track record leading global or multi-site studies.Strong understanding of FDA, EMA, and ICH/GCP guidelines.Experience with EDC, CTMS, and regulatory submission systems.Skilled in vendor oversight, budget forecasting, and project tracking.Excellent communication, leadership, and problem-solving skills.Experience with Phase 1-IV clinical trials.The Senior Clinical Project Manager should have experience with the FDA, EMA, GCP, and ICH guidelines.Experience managing CROs, Vendors, and multi-site global trials.Preferred Experience/Skills for the Senior Clinical Manager (Clinical Trials):Prior work in rare disease or liver disease trials is a plus.Education Requirements:Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field is required.Master's or Doctoral degree is preferred.Benefits:Competitive compensation and annual bonus structure.Health, dental, and vision coverage from day one.401(k) with employer match.Generous PTO and company holidays.Professional development support.Opportunities for advancement within a growing Clinical team.

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