Digital Technology Program Manager
The position will be based in Princeton, NJ with occasional travel to New York City.
Job Reports To
Science Director Outcomes Research, Clinical Outcomes Unit
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 CHDI Science Director(s) in managing digital health technology research projects and activities in their clinical portfolio (including, but not limited to clinical studies and trials). This detail-oriented, self-starting individual will work closely 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 digital clinical research and development efforts.
A Digital Technology Program Manager will be expected to work closely with project Science Directors and others within CHDI to:
- define a vision for digital assessments and products for HD research
- prioritize product features and capabilities
- identify, assess, and select digital health technologies to meet various internal and external research needs
- work with internal and external stakeholders to develop and execute digital health technology studies and surveys, data collection, and digital health technology validation in HD
- communicate best practices in digital health technology assessment and the results of digital health technology assessment studies to the HD research community
- keep abreast of global regulatory feedback, decisions, and guidance bearing on the use of digital health technology in clinical research
- ensure CHDI is aware of general digital health technology assessment trends and strategies including those occurring in other neurological disorders (e.g., Parkinson’s disease)
- plan digital health technology clinical projects
- maintain expertise in all matters relating to participant privacy and data protection in the collection, transfer, processing, and analysis of digital health technology data within and outside of the United States.
- outline the plan for achieving success
- develop and/or oversee development of other project-related documents including protocols, case report forms, study manuals, informed consent forms, monitoring plans, communication plans, tracking tools, and other project tools as needed
- evaluate and select 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
- 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)
- other duties as requested
The successful candidate will:
- have a bachelor’s degree in computer science, biomedical engineering, or related field; master’s degree in computer science, biomedical engineering, or related field preferred
- have at least 2 years of pharmaceutical industry/biotech/CRO/academic experience in clinical research that included exposure to or responsibility for site agreements, informed consent forms, institutional review board submissions, budgeting, contracting, request for proposals (RFPs) and study execution
- have experience in the selection and evaluation of digital health technologies or research where data from digital health technologies were collected and analyzed.
- 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
- be comfortable in a fast-paced, dynamic environment
- have excellent oral and written communication skills
- have experience in collaborative document development and management ideally through the publication of a scientific manuscript
- have excellent interpersonal skills as demonstrated by the ability to effectively manage relationships in a multi-stakeholder environment
- be comfortable and flexible with performing various roles (e.g., leadership, supportive, etc.) within and across project teams
- be willing to contribute to a positive, solutions-focused work environment
- have experience and comfort with a hybrid work environment
- have familiarity with regulatory documents bearing on clinical outcome assessment (e.g., FDA’s Patient Focused Drug Develop guidance documents) and the use of digital health technologies in clinical research (e.g., FDA’s Digital Health Technologies for Remote Data Acquisition in Clinical Investigations)
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
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.
For more information about CHDI, please go to www.chdifoundation.org
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