Clinical Research Program Manager

Job Title

Job Location

The position will be based in Princeton, N.J. (currently hybrid) with occasional travel.

Job Reports To

Director of Clinical Operations

Other

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

Job Description

CHDI is a privately-funded, not-for-profit biomedical research organization devoted to a single disease – Huntington’s disease (HD). Our mission is to develop drugs that will slow the progression of HD and provide meaningful clinical benefit to patients. CHDI is a “science first” organization; our foremost consideration is to do the best science as quickly and efficiently as possible.

CHDI’s Clinical Team oversees a portfolio of projects aimed at understanding the natural progression of HD, developing the best biomarkers and outcome measures for use in clinical trials, finding ways to expedite and improve the execution of clinical trials, paving relevant regulatory pathways, and working with external partners to support their clinical development plans. The team engages a diverse array of partners to help manage this portfolio, including academic institutions, government agencies, contract research organizations (CROs), biotech and pharmaceutical companies.

We are seeking a highly motivated and organized individual to assist managing projects in the clinical portfolio (including, but not limited to clinical studies and trials). This detail-oriented, self-starting individual will work closely in a team and with internal colleagues (scientific, legal and financial) and external collaborators (physicians, academic institutions, CROs, and biotech and pharmaceutical companies) on all aspects of CHDI’s clinical research and development efforts.

Job Responsibilities

A Clinical Research Program Manager will be expected to work closely with study teams, Directors and others within CHDI in the following areas:

plan, implement, and manage all aspects of clinical operations, including timelines, budgets, and resource allocation
oversee the lifecycle of clinical studies, from protocol development through study closeout
ensure all project activities adhere to company policies, regulatory standards, and ethical guidelines.
demonstrate understanding of other functions’ roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations
oversee and maintain relationships with central IRB vendors, ensuring all submissions and approvals are handled efficiently and in compliance with protocol, SOPs, ICH GCP, and relevant country regulations. Maintain up-to-date knowledge of contract terms and manage any amendments or issues that arise.
Review and management of site ICFs, including the processing of these ICF per internal processes
oversee CRO vendors and service providers, ensuring their activities align with project goals and compliance requirements develop, manage, and monitor budgets related to CHDI agreements, ensuring financial efficiency, adherence to contract terms, and alignment with overall project objectives.
serve as the primary point of contact between vendors and internal teams, facilitating communication and resolving any cross-functional challenges develop and maintain detailed project plans for all vendor management activities, including timelines, milestones, and deliverables.
provide regular financial reports and address any budgetary variances and drive contract amendments as needed work closely with clinical operations, finance, legal, and other departments to ensure cohesive management of vendor activities.
provide regular updates to senior leadership, highlighting key achievements, risks, and issues continuously assess and enhance vendor management processes, incorporating lessons learned and industry best practices to improve efficiency and effectiveness
develop and review project descriptions, project budgets and associated contracts (e.g., funding, CROs, etc.) to assure compliance with Foundation policies.

manage and drive various aspects of select clinical studies and process improvement projects

proactively identify issues and facilitate discussion of potential solutions that can be implemented by the project team
maintain strong relationships with key stakeholders and partners in collaborative efforts (universities, government agencies, not-for-profit organizations, pharma/biotech companies)

liaise with internal and external stakeholders, such as CHDI legal and finance, other clinical team members, institutional review boards, and site staff (as needed), etc.
develop and/or oversee development of other project-related documents including protocols, case report forms, study manuals, SOPs, informed consent forms, monitoring plans, communication plans, tracking tools, and other project tools as needed

anticipate areas of risk, and plan and implement solutions to mitigate these risks

assure good communication among the project team which is made up of members from within the organization and outside vendors/collaborators
track and report on progress of clinical projects to the extended project team and management as appropriate
foster a personal sense of accountability and ownership in your role within the clinical operations team

Qualifications

The successful candidate will have:

Bachelor’s or Master’s degree in life sciences, healthcare, project management/business, or related field
experience in pharmaceutical industry/biotech/CRO/academic experience in clinical research project/trial management including budgeting, contracting and study execution
demonstrated experience in managing vendors, including RFP processes and contract negotiations
knowledge of, and experience applying GCP and ICH Guidelines, including detailed knowledge of clinical document management
proactive, creative problem-solving skills and be open to innovative solutions
high attention to detail and care about the quality of their work
demonstrated ability to multitask, prioritize responsibilities, and work effectively in a fast-paced environment
demonstrated ability to work independently in a distributed, interdisciplinary, team-oriented environment
excellent communication skills (including ability to write clearly and concisely), with the ability to work effectively with cross-functional teams and external collaborators
excellent project management skills, with the ability to manage multiple complex projects simultaneously
proficiency and willingness to expand/improve their skills in the following Microsoft applications: Excel, PowerPoint, and Word
be comfortable in a fast-paced, dynamic, and highly detailed-oriented environment
willingness to travel as needed to visit study sites and attend meetings or training sessions

Additional Skills

An ideal candidate might also have:

knowledge of regulatory requirements related to clinical trials and vendor management experience in managing other SaaS vendors (CTMS, ePRO, EDC, etc.)
experience in a global clinical research environment.
certification in Project Management (PMP) or Clinical Research (ACRP/SoCRA) is a plus
advanced skills using Excel to develop tracking and budget/invoicing spreadsheets
proficiency in MS Project and other project management tools and software
experience with regulatory document management
experience working on CNS clinical research or drug development
experience negotiating vendor agreements

About CHDI Foundation, Inc.

CHDI is a private, not-for-profit research organization. We work with an international network of scientists to discover drugs that slow the progression of Huntington’s disease (HD) and provide meaningful clinical benefit to patients. We seek to accelerate scientific progress by serving as a collaborative enabler. We encourage and support cooperation and collaboration among HD researchers. Our strategy is to encourage researchers to develop practical ideas, useful research materials, and powerful technologies, often by providing financial support.

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.

About CHDI Management, Inc:

CHDI Management, Inc. was established in 2002 to provide administrative, management and grant making services to CHDI Foundation, Inc.

About our Donors

CHDI’s activities focus solely on the identification and development of drugs that delay or slow Huntington’s disease. We are indebted to our donors, whose generosity and guidance have made possible this exclusive focus on science.

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