Clinical Research Program Manager - Enroll 2.0

CHDI Management; Princeton (NJ); Ibrido; USD 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

CHDI Management, based in Princeton, is seeking a Clinical Research Program Manager (CPM) to lead vendor management, study operations, and cross‑functional execution for Enroll 2.0. The role requires coordinating with CROs, sites, and internal teams to maintain timelines and budgets in a hybrid Princeton setting.

The CPM will manage study documents, risk, and communication tools, supporting site activation, go‑live planning, and regulatory compliance while traveling occasionally as needed.

Competenze

• Bachelor’s or master’s degree in life sciences, healthcare, or a related field.
• Experience managing projects or trials in pharma, biotech, CRO, or academic clinical research.
• Experience leading complex, multi-stakeholder study operations from planning to close-out.
• Proven vendor management experience including RFPs and contract negotiations.
• Knowledge of GCP and ICH guidelines and clinical document management.
• Excellent project management skills with ability to handle multiple projects and fast pace.
• Strong risk and issue management and proactive problem solving.
• Advanced Microsoft Excel, PowerPoint, Word; willingness to expand skills.
• Ability to work independently in a distributed, interdisciplinary team.
• Excellent communication and collaboration with cross-functional teams.
• Willingness to travel occasionally.

Mansioni

• Vendor management: lead selection, onboarding, negotiations, renewals, and termination.
• Oversee CROs and service providers to meet timelines, quality, and regulatory standards.
• Develop and monitor budgets, track invoices, and identify cost-saving opportunities.
• Monitor SLAs and KPIs; conduct performance reviews and corrective actions.
• Identify vendor risks and manage scope changes with Clinical Ops, Science, Legal, and Finance.
• Serve as liaison between vendors and internal teams, reporting status and risks to leadership.
• Drive continuous improvement of vendor management processes.
• Manage key aspects of clinical studies and documentation.
• Coordinate with IRBs, sites, and external partners across academia, industry, government, and non-profits.
• Develop study plans, monitoring, and communication tools.
• Track progress and report to management.
• Support site management and ensure successful study execution.

Conoscenze

Vendor management

Project leadership

GCP/ICH knowledge

Excel/PowerPoint/Word

Cross-functional collaboration

Formazione

Bachelor’s or Master’s in life sciences or related field

Strumenti

MS Project

CTMS/ePRO/EDC

Excel

PowerPoint

Word

Descrizione del lavoro

Job Title

Clinical Research Program Manager (CPM) – Enroll 2.0

Job Location

The 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 To

Director, Enroll 2.0 Planning & Implementation

Salary Range

$80,000 – $120,000. Exact compensation will vary based on experience.

Other

Vaccination against COVID-19 is a prerequisite for employment at CHDI Management.

About CHDI Foundation, Inc.

CHDI Foundation, Inc. is a privately funded nonprofit biomedical research organization exclusively dedicated to collaboratively developing therapeutics that will substantially improve the lives of those affected by Huntington’s disease (HD). Our scientists work closely with a network of more than 700 researchers in academic and industrial laboratories around the world in the pursuit of these novel therapies, providing strategic scientific direction to ensure that our common goals remain in focus. This helps bridge the translational gap that often exists between academic and industrial research pursuits and that adds costly delays to therapy development. In its role as a collaborative enabler, CHDI seeks to bring the right partners together to identify and address critical scientific issues and move drug candidates to clinical evaluation as rapidly as possible. Our activities extend from exploratory biology to the identification and validation of therapeutic targets, and from drug discovery and development to clinical studies and trials. More information about CHDI can be found at www.chdifoundation.org.

CHDI’s Clinical Team

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.

Job Responsibilities

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; elevate 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 Skills

An 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

About CHDI Foundation, Inc.

CHDI Foundation is a private nonprofit biomedical research organization exclusively dedicated to collaboratively developing therapeutics that will substantially improve the lives of those affected by Huntington’s disease (HD).

About CHDI Management, Inc.

Our staff works for CHDI Management, Inc., which was established in 2002 to provide administrative and management services to CHDI Foundation, Inc.

About our Donors

CHDI’s activities focus solely on the collaborative development of therapeutics that will substantially improve the lives of those affected by Huntington’s disease. We are indebted to our donors, whose generosity and guidance have made possible this exclusive focus on science.