Job TitleClinical Research Program Manager (CPM) - Enroll 2.0
Job LocationThe position will be based in Princeton, N.J. (currently hybrid) with occasional travel. Requires 2 days per week in our Princeton office. Local candidates only. Resumes without a local location will not be considered.
Job Reports ToDirector, Enroll 2.0 Planning & Implementation
Salary Range: $80,000 - $120,000. Exact compensation will vary based on experience.
OtherVaccination against COVID-19 is a prerequisite for employment at CHDI Management.
CHDI's Clinical Team oversees a portfolio of projects that aim to understand the natural progression of HD, develop the best biomarkers and outcome measures for clinical trials, expedite and improve trial execution, and pave relevant regulatory pathways. The team also works with external partners to support their clinical development plans, including academic institutions, government agencies, contract research organizations (CROs), and biotech and pharmaceutical companies.
We are seeking a highly motivated, organized, and detail-oriented self-starter to help manage projects in the clinical portfolio (including but not limited to clinical studies and trials). You will work closely with the team, internal colleagues (scientific, legal, and financial), and external collaborators (CROs, and sometimes academics or biotech and pharmaceutical companies) on all aspects of CHDI's clinical research and development efforts, with a particular focus on the operational planning, coordination, and delivery of complex, multi-vendor studies.
Job ResponsibilitiesA Clinical Research Program Manager works closely with study teams, Directors, and others within CHDI in the following areas:
Vendor management
- Lead end-to-end vendor management: selection, onboarding, contract negotiation, renewals, and termination.
- Oversee CROs and service providers to ensure alignment with project objectives, quality standards, timelines, and regulatory requirements.
- Develop, manage, and monitor project budgets; track invoices, resolve variances, and identify cost-efficiency opportunities.
- Monitor vendor performance against Service Level Agreements (SLAs) and Key Performance Indicators (KPIs); lead performance reviews and corrective action plans.
- Identify and mitigate vendor-related risks; manage scope changes and escalations with Clinical Operations, Science, Legal, and Finance.
- Serve as the primary liaison between vendors and internal teams; provide regular status, financial, and risk updates to leadership.
- Continuously improve vendor management processes and strengthen strategic vendor partnerships.
Clinical study management
- Manage key aspects of assigned clinical studies and related process improvement initiatives.
- Develop and/or oversee essential study documentation, including protocols, case report forms, standard operating procedures, monitoring plans, and communication tools.
- Coordinate with internal teams, institutional review boards, study sites, and external partners across academia, industry, government, and non-profits.
- Identify risks and issues early, implement mitigation strategies, and communicate clearly across project teams.
- Track, analyze, and report study progress to project teams and management.
- Support site management activities and resolve operational needs to ensure successful study execution.
Study operations management
- Develop and maintain integrated project plans, timelines, and milestones for complex studies; manage cross-functional dependencies and the critical path.
- Drive study start-up and implementation, including site activation, vendor and system readiness, training, and go-live planning.
- Establish and run the team's operating rhythm: meeting cadence, status reporting, decision logs, and tracking of risks, assumptions, issues, and dependencies.
- Define roles, responsibilities, and decision rights (e.g., RACI) across internal teams and vendors.
- Manage change control: assess impacts on scope, timeline, and budget, and bring decisions to resolution with stakeholders.
- Align large, distributed stakeholder groups on priorities, trade-offs, and decisions; escalate promptly when needed.
- Monitor operational metrics (e.g., enrollment, site performance, data quality, and spend) and implement corrective actions.
- Build and improve scalable processes, trackers, and tools that support consistent study execution and inspection readiness.
Qualifications- A bachelor's or master's degree in life sciences, healthcare, project management, business, or a related field
- Experience in the pharmaceutical, biotech, or CRO industry, or in academic clinical research, managing projects or trials, including operations, budgeting, contracting, and study execution
- Demonstrated experience managing complex, multi-stakeholder study operations from planning and start-up through execution and close-out
- Demonstrated experience managing vendors, including RFP processes and contract negotiations
- Knowledge and applied experience of GCP and ICH guidelines, including clinical document management
- Excellent project management skills, including the ability to manage multiple complex projects simultaneously, prioritize effectively, and perform in a fast-paced environment
- Strong risk and issue management skills, with the ability to anticipate problems and drive timely resolution
- Proactive, creative problem-solving skills and openness to innovative solutions
- High attention to detail and commitment to quality
- Proficiency in Microsoft Excel, PowerPoint, and Word, and willingness to expand those skills
- Ability to work independently in a distributed, interdisciplinary, team-oriented environment
- Excellent communication skills, including the ability to write clearly and concisely and to work effectively with cross-functional teams and external collaborators
- Willingness to travel occasionally to attend meetings or training sessions
Additional SkillsAn ideal candidate might also have:
- Advanced Excel skills for building tracking and budget/invoicing spreadsheets
- Proficiency in MS Project and other planning tools, including building integrated timelines, RACI matrices, and risk/issue logs
- Knowledge of regulatory requirements for clinical trials, and experience managing SaaS vendors (CTMS, ePRO, EDC, etc.)
- Experience in a global clinical research environment
- Experience with regulatory document management
- Experience in CNS clinical research or drug development
- Certification in Project Management (PMP) or Clinical Research (ACRP/SoCRA) is a plus
