What are the responsibilities and job description for the Senior Clinical Project Manager position at Actalent?
We are seeking a candidate for the role of Senior Clinical Project Manager. You will be responsible for the planning, execution, and oversight of clinical trials across multiple phases, ensuring compliance with regulatory requirements, timelines, and budget constraints. This role involves cross-functional team leadership, vendor management, and collaboration with key stakeholders, including investigators, regulatory agencies, and internal teams. The Sr. CPM will play a pivotal role in driving operational excellence in clinical trial execution.
Job 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 mange 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 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 and Quality Control, Legal, Finance, and Senior Leadership, as well as external partners (CROs, Laboratories, Specialty service-providers, Investigators).
- 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.
- Contribute to developing the organizational systems, including development of the SOPs, document management system and project finance management.
- Ensure compliance to regulatory requirements/ standard operating procedures and timely management of project activities.
- Any other duties as assigned by Supervisor.
Additional Skills & Qualifications:
- Proficiency in clinical trial management systems (CTMS), EDC, and regulatory submission platforms
- Bachelor’s degree in life sciences, pharmacy, nursing, or a related field minimum
- 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, 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.
Experience Level
Expert Level
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 Pennington,NJ.
Application Deadline
This position is anticipated to close on Apr 14, 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.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
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.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $130,000 - $140,000
