Clinical Research Program Manager - Wet Biomarkers
CHDI Management
Summary
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 description
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
- Plan clinical protocols and wet biomarker testing projects
- Develop and/or oversee development of 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 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 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
- Bachelor's degree in life sciences, healthcare, project management/business, or related field required; master's degree preferred
- 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
- Proactive, creative problem solver open to innovative solutions
- Detail-oriented and cares about quality of work
- Demonstrated ability to work independently in a distributed, interdisciplinary, team-oriented environment
- Proficient in Microsoft Excel, PowerPoint, and Word
- Comfortable in a fast-paced, dynamic environment
- Excellent oral and written communication skills
- Experience in collaborative document development and management
- Excellent interpersonal skills with ability to manage relationships in a multi-stakeholder environment
- Comfortable and flexible performing various roles within and across project teams
- Willing to contribute to a positive, solutions-focused work environment
Additional Skills
- Knowledge of and experience applying Good Clinical Practice (GCP) and ICH Guidelines
- Advanced skills using Excel to develop tracking and budget/invoicing spreadsheets and proficiency in MS Project
- Experience working on CNS clinical or basic research or drug development
- Experience with regulatory agencies
- Experience negotiating vendor agreements
Requirements
- Bachelor's degree in life sciences, healthcare, project management/business, or related field
- At least 2 years of pharmaceutical industry/biotech/CRO/academic experience in basic or clinical research project or clinical trial management
- Experience with site agreements, informed consent forms, institutional review board submissions, budgeting, contracting, RFPs, and study execution
- Proactive, creative problem solver
- Detail-oriented
- Ability to work independently in a distributed, interdisciplinary, team-oriented environment
- Proficiency in Microsoft Excel, PowerPoint, and Word
- Excellent oral and written communication skills
- Experience in collaborative document development and management
- Excellent interpersonal skills for multi-stakeholder relationship management
- Flexibility to perform various roles within and across project teams
Benefits
- Hybrid work (2 days/week in office)
- COVID-19 vaccination required
Company overview
CHDI Management, Inc. is a specialized administrative and management services organization established in 2002 to support CHDI Foundation, Inc., a private nonprofit biomedical research entity exclusively dedicated to Huntington's disease (HD) therapeutics development. Operating as the operational backbone of the CHDI ecosystem, CHDI Management provides comprehensive administrative, management, and grant-making services from its offices in New York, Los Angeles, and Princeton. The organization employs a unique "virtual pharma" model, managing a global network of over 700 researchers across academic and industrial laboratories worldwide. CHDI Management coordinates strategic scientific direction, project management, and collaborative initiatives aimed at accelerating therapeutic development for HD. Their services encompass everything from exploratory biology and target validation to drug discovery, clinical development, and trial management. The organization also oversees Enroll-HD, a worldwide clinical research platform with more than 28,000 participants across 23 countries, and manages the HD Community BioRepository that provides critical research reagents to the scientific community. As a nonprofit entity, CHDI Management's mission is to bridge the translational gap between academic research and clinical application, de-risking therapeutic approaches to facilitate pharmaceutical partnerships and ultimately deliver meaningful treatments to HD patients as rapidly as possible.