Senior Clinical Project Manager

Atrium is seeking on behalf of our client a Senior Clinical Project Manager based in Princeton, NJ.

A background check may be run only after a conditional offer is made, where permitted by law.

Position: Senior Clinical Project Manager

Location: Princeton, NJ

Employment Type: Full-time

Compensation: 120000-140000

Position Overview

The Senior Clinical Project Manager will lead and oversee all aspects of clinical trial execution from protocol development through study closeout. This role ensures compliance with regulatory standards, manages timelines and budgets, and fosters collaboration across internal teams and external partners. The position requires strong leadership and strategic thinking to drive successful trial outcomes. Must be legally authorized to work in the United States.

Responsibilities

• Lead end-to-end clinical trial management from protocol development to study closeout, ensuring adherence to timelines and quality standards.
• Develop and maintain detailed project plans, timelines, and budgets to support operational efficiency.
• Collaborate with regulatory teams for submissions, amendments, and compliance-related documentation.
• Address protocol deviations, audit findings, and ensure inspection readiness.
• Select, negotiate, and manage relationships with CROs, central labs, and other external vendors.
• Track performance metrics and ensure service level agreements are met.
• Proactively identify study risks and develop mitigation strategies.
• Monitor trial-related invoices and payments in collaboration with finance teams.
• Act as primary point of contact for all internal and external stakeholders.
• Provide leadership and mentorship to junior project managers, CRAs, and study coordinators.
• Foster collaboration among cross-functional teams, including Clinical Operations, Data Management, Medical Writing, Quality Assurance, Legal, Finance, and Senior Leadership.
• Ensure high-quality data collection and adherence to data integrity standards.
• Work closely with data management and biostatistics teams to ensure timely database locks.
• Develop strategies to optimize patient recruitment and retention.
• Oversee site relationships, investigator engagement, and performance metrics.
• Support protocol development and feasibility assessments.
• Contribute to clinical development plans and operational feasibility considerations.
• Assist in developing organizational systems, including SOPs and document management systems.
• Ensure compliance with regulatory requirements and timely management of project activities.

Required Experience/Skills

• Strong leadership, communication, and negotiation skills.
• Ability to work in a fast-paced environment and manage multiple priorities.
• Proficiency in clinical trial management systems (CTMS), EDC, and regulatory submission platforms.
• Excellent problem-solving and risk management abilities.
• Financial acumen for budget forecasting and cost control.
• 7+ years of experience in clinical trial management within pharmaceutical, biotech, or CRO industry.
• Proven experience in leading Phase I-IV clinical trials.
• Strong understanding of GCP, ICH guidelines, FDA, EMA, and other regulatory requirements.
• Experience managing CROs, vendors, and multi-site global trials.

Preferred Experience/Skills

• Prior experience in neurology or rare diseases.
• Experience working in FDA-regulated and/or EMA-regulated environments.
• Knowledge of adaptive trial designs and decentralized clinical trials.

Education Requirements

• Bachelor’s degree in life sciences, pharmacy, nursing, or a related field (Master’s or PhD preferred).

Benefits

If eligible under the ACA, medical, dental and vision benefits and time off in accordance with local paid sick time laws will be offered. Additional benefits may include paid holidays, a 401(k)-retirement plan, life insurance, disability coverage, and an employee assistance program, where applicable. Other compensation programs may include overtime, shift differentials, bonuses, commissions, or other incentive compensation, where applicable.

Commitment to Diversity

As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.

EOE/M/F/D/V/SO

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