Clinical Research Program Manager - Wet Biomarkers

CHDI Management • Full-time • Princeton, New Jersey, United States • 16h ago

Title:
Clinical Research Program Manager – Wet Biomarkers

Location:
The position will be based in Princeton NJ (currently hybrid) with occasional travel. 2 days per week in the office required. Candidates not local to Princeton, NJ will not be considered.

Reports To:
Clinical Operations Team Lead

Salary Range:
$80,000–$120,000. Exact compensation will vary based on experience

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

About CHDI Foundation, Inc.
CHDI Foundation, Inc. is a privately funded nonprofit biomedical research organization exclusively dedicated to collaboratively developing therapeutics that will substantially improve the lives of those affected by Huntington’s disease (HD). Our scientists work closely with a network of more than 700 researchers in academic and industrial laboratories around the world in the pursuit of these novel therapies, providing strategic scientific direction to ensure that our common goals remain in focus. This helps bridge the translational gap that often exists between academic and industrial research pursuits and that adds costly delays to therapy development. In its role as a collaborative enabler, CHDI seeks to bring the right partners together to identify and address critical scientific issues and move drug candidates to clinical evaluation as rapidly as possible. 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. More information about CHDI can be found at www.chdifoundation.org.

Job Description:
We are seeking a highly motivated and organized individual to join the Clinical Program Management Office and assist CHDI Science Directors managing projects in the clinical wet biomarker research portfolio. 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 studies while reporting to the Program Manager Team Lead under the Clinical Program Management Office.

Job Responsibilities:
A Clinical Research Program Manager will be expected to work closely with project Science Directors and others within CHDI to:

plan clinical protocols and wet biomarker testing projects
develop and/or oversee development of other project-related documents including protocols, case report forms, study laboratory or procedure manuals, informed consent forms, monitoring plans, communication plans, tracking tools, and other project tools as needed to support biofluid or tissue collection
develop and review project descriptions, project budgets and associated contracts to assure compliance with Foundation policies
evaluate and select CROs, contractors and other outside vendors and establish contracts as needed for wet biomarker testing
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
maintain strong relationships with key stakeholders and partners in collaborative efforts
other duties as requested

Qualifications:

The successful candidate will:
have a bachelor’s degree in life sciences, healthcare, project management/business, or related field required; master’s degree in life sciences, project management/business, or related field preferred.
have at least 2 years of pharmaceutical industry/biotech/CRO/academic experience in basic or clinical research project or clinical trial management including site agreements, informed consent forms, institutional review board submissions, budgeting, contracting, request for proposals (RFPs) 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
have excellent oral and written communication skills
have experience in collaborative document development and management
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

Additional Skills

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 and have proficiency in MS Project
experience working on CNS clinical or basic research or drug development
experience with regulatory agencies
experience negotiating vendor agreements

About CHDI Foundation, Inc.
CHDI Foundation is a private nonprofit biomedical research organization exclusively dedicated to collaboratively developing therapeutics that will substantially improve the lives of those affected by Huntington’s disease (HD).

About CHDI Management, Inc.
Our staff works for CHDI Management, Inc., which was established in 2002 to provide administrative and management services to CHDI Foundation, Inc.

About our Donors
CHDI’s activities focus solely on the collaborative development of therapeutics that will substantially improve the lives of those affected by 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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