Clinical Research Program Manager

Job Title

Clinical Research Program Manager (CPM)

Job Location

The position will be based in Princeton, N.J. (currently hybrid) with occasional travel. MUST BE LOCAL TO PRINCETON, NJ.

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. Our mission is to develop drugs that will slow the progression of Huntington’s disease (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 disease, 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 project the study teams, Directors and others within CHDI to:

• independently manage a portfolio of 20 clinical study sites, ensuring adherence to study protocol, regulatory requirements, and internal SOPs and guidelines
• foster strong relationships with site staff, investigators, and key stakeholders (including CROs
• and other external clinical service providers) to promote collaboration and support site success
• conduct regular check-ins with sites to assess performance, address concerns, and provide support as needed
• monitor site activities from study activation through closeout, identifying and resolving any issues that may arise
• ensure all site staff are appropriately trained on study protocols, procedures, and data entry requirements; facilitate training sessions as needed and provide ongoing support to ensure compliance with study requirements
• maintain up-to-date knowledge of each site's Institutional Review Board (IRB) requirements and ensure compliance with ethical standards including overseeing the timely completion and submission of essential study documents, including regulatory submissions and informed consent forms (ICFs)
• assist sites with data entry and resolution of queries to ensure accurate and complete data collection
• serve as the primary point of contact for site inquiries and escalate issues as needed to ensure timely resolution
• demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations
• 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, site staff, institutional review boards, 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
• draft, review and negotiate changes in informed consent forms
• evaluate, select, and manage CROs, contractors and other outside vendors
• 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
• reconcile budgets and authorize payments

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 is a plus

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

proficiency and willingness to expand/improve their skills in the following Microsoft applications: Excel, PowerPoint, and Word

be comfortable in a fast-paced, dynamic 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 site management and monitoring processes, and quality assurance procedures

knowledge of, and experience applying Good Clinical Practice (GCP) and ICH Guidelines

advanced skills using Excel to develop tracking and budget/invoicing spreadsheets; proficiency in MS Project

certification in clinical research (e.g., CCRA, CCRP)

experience with ICF negotiations and 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.