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
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
