Senior Clinical Project Manager

Senior Clinical Project Manager

We are seeking a dedicated Senior Clinical Project Manager responsible for overseeing the planning, execution, and management of clinical trials across multiple phases. This role ensures compliance with regulatory requirements, timelines, and budget constraints while driving operational excellence in clinical trial execution.

Responsibilities

Lead end-to-end clinical trial management from protocol development to study closeout.

Develop and maintain detailed project plans, timelines, and budgets.

Collaborate with regulatory teams for submissions, amendments, and compliance-related documentation.

Address protocol deviations, audit findings, and 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.

Address operational challenges, protocol deviations, and recruitment / retention issues.

Ensure efficient resource allocation to optimize study costs.

Monitor trial-related invoices and payments in collaboration with finance teams.

Act as the primary point of contact for all internal and external stakeholders.

Provide leadership and mentorship to junior project managers, CRAs, and study coordinators.

Facilitate collaboration among cross-functional teams including Clinical Operations, Data Management, Medical Writing, Quality Assurance, and other departments.

Ensure high-quality data collection and adherence to data integrity standards.

Work closely with data management and biostatistics teams to ensure timely database locks.

Provide regular study updates to senior leadership and stakeholders.

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, study endpoints, and operational feasibility considerations.

Develop organizational systems including SOPs, document management systems, and project finance management.

Ensure compliance with regulatory requirements and standard operating procedures.

Perform any other duties as assigned by the supervisor.

Essential 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) and regulatory submission platforms.

Excellent problem-solving and risk management abilities.

Financial acumen for budget forecasting and cost control.

Additional Skills & Qualifications

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

7+ years of experience in clinical trial management within the 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.

Prior experience in neurology and rare diseases is a plus.

Experience working in an FDA-regulated and / or EMA-regulated environment.

Knowledge of adaptive trial designs and decentralized clinical trials is an advantage.

Pay and Benefits

The pay range for this position is $130000.00 - $140000.00 / yr.

Other benefits are : Tuition reimbursement : 8K per year Holiday Pay 12 per year Vacation : at least 10 days annually Sick days 5 Annual performance bonus 10 15% Cell phone reimbursement $125 per month

Workplace Type

This is a hybrid position in Bridgewater, NJ.

Application Deadline

This position is anticipated to close on Oct 15, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.