Clinical Research Program Manager (Neuroimaging)

CHDI Management

1d•$90,000 - $120,000•Hybrid

About The Position

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 Neuroimaging Science Directors managing projects in the 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 clinical research and development efforts.

Requirements

have a Bachelors or Master’s degree in life sciences, healthcare, project management/business, or related field
have at least 5 years of pharmaceutical industry/biotech/CRO/academic experience in clinical research project/trial management including budgeting, contracting and study execution
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 proficient in the following Microsoft applications: Excel, PowerPoint, and Word
be comfortable in a fast-paced, dynamic environment

Nice To Haves

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 working with MRI or PET neuroimaging studies
experience with regulatory agencies
experience negotiating vendor agreements

Responsibilities

plan clinical neuroimaging projects
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, informed consent forms, monitoring plans, communication plans, tracking tools, and other project tools as needed
evaluate and select 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)