Clinical Research Program Manager - Wet Biomarkers
About The Position
CHDI Foundation, Inc. is a privately funded nonprofit biomedical research organization dedicated to collaboratively developing therapeutics for people affected by Huntington’s disease. The Clinical Research Program Manager will join the Clinical Program Management Office and assist CHDI Science Directors with projects in the clinical wet biomarker research portfolio. The role works closely with internal scientific, legal, and financial colleagues and external collaborators, including physicians, academic institutions, CROs, and biotechnology and pharmaceutical companies, on all aspects of CHDI’s clinical studies. The position reports to the Clinical Operations Team Lead.
Requirements
- Bachelor’s degree in life sciences, healthcare, project management/business, or a related field.
- At least 2 years of pharmaceutical industry, biotechnology, CRO, or academic experience in basic or clinical research project management or clinical trial management, including site agreements, informed consent forms, institutional review board submissions, budgeting, contracting, requests for proposals, and study execution.
- Proactive, creative problem-solving skills and openness to innovative solutions.
- Attention to detail and commitment to quality work.
- Demonstrated ability to work independently in a distributed, interdisciplinary, team-oriented environment.
- Proficiency in Microsoft Excel, PowerPoint, and Word.
- Comfort working in a fast-paced, dynamic environment.
- Excellent oral and written communication skills.
- Experience with collaborative document development and management.
- Excellent interpersonal skills and ability to manage relationships in a multi-stakeholder environment.
- Flexibility and comfort performing different roles, including leadership and support, across project teams.
- Willingness to contribute to a positive, solutions-focused work environment.
- COVID-19 vaccination is a prerequisite for employment at CHDI Management.
Nice To Haves
- Master’s degree in life sciences, project management/business, or a related field.
- Knowledge of and experience applying Good Clinical Practice (GCP) and ICH Guidelines.
- Advanced Excel skills for developing 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.
Responsibilities
- Work with project Science Directors and others at CHDI to plan clinical protocols and wet biomarker testing projects.
- Develop or oversee development of project documents, including protocols, case report forms, study laboratory or procedure manuals, informed consent forms, monitoring plans, communication plans, tracking tools, and other materials supporting biofluid or tissue collection.
- Develop and review project descriptions, budgets, and associated contracts to ensure compliance with Foundation policies.
- Evaluate and select CROs, contractors, and other vendors, and establish contracts for wet biomarker testing as needed.
- Anticipate project risks and plan and implement mitigation solutions.
- Support effective communication among internal project team members and external vendors and collaborators.
- Track and report clinical project progress 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.
- Perform other duties as requested.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
