Clinical Research Program Manager
Job Location (hybrid)
The position will be based in Princeton, NJ (currently hybrid) with occasional travel to New York City and Los Angeles
Job Reports To
Director of Clinical Operations and Enroll-HD Regional Manager
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.
A Clinical Research Program Manager will be expected to work closely with project the study teams, Science Directors and others within CHDI to:
- manage and drive various aspects of clinical studies and process improvement projects
- liaise with internal and external stakeholders, such as CHDI legal and finance, other clinical team members, site staff, institutional review boards, etc.
- develop and review project descriptions, project budgets and associated contracts (e.g., funding, CROs, etc.) to assure compliance with Foundation policies
- 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
- proactively identify problem 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)
- oversees site interactions post study activation through site closeout
- review the project oversight dashboards and other study systems (e.g., Electronic Data Capture (EDC), Trial Master File (TMF), Central Data dashboards), to oversee site activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects according to plan
- demonstrates understanding of other functions’ roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations
The successful candidate will:
- have a Bachelor’s or Master’s degree in life sciences, healthcare, project management/business, or related field
- have experience in pharmaceutical industry/biotech/CRO/academic experience in clinical research project/trial management including budgeting, contracting and study execution is a plus
- be a proactive, creative problem solver and open to innovative solutions
- be detail-oriented and care about the quality of her or his work
- have demonstrated the ability to work independently in a distributed, interdisciplinary, team-oriented environment
- have excellent communication skills
- be proficient in the following Microsoft applications: Excel, PowerPoint, and Word
- be comfortable in a fast-paced, dynamic environment
An ideal candidate might also have:
- 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
- experience working on CNS clinical research or drug development
- experience with regulatory agencies
- experience negotiating vendor agreements
- PMP certification
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.