Clinical Research Manager manages the clinical monitoring process and the administration of clinical trials. Supervises CRAs in in-house and on-site monitoring, filing, and clinical trial administration. Being a Clinical Research Manager oversees adherence to SOPs, Good Clinical Practice and FDA regulations. Helps with the development and implementation of clinical processes, procedures, and programs. Additionally, Clinical Research Manager may require a master's degree in nursing. May require ACRP or SOCRA Clinical Research Professional exam completion. Typically reports to a director. The Clinical Research Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Clinical Research Manager typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Job Title
Clinical Research Program Manager (CPM)
Job Location
The position will be based in Princeton, N.J. (currently hybrid) with occasional travel. Only local candidates will be considered.
Job Reports To
Director of Clinical Operations
Other
Vaccination against COVID-19 is a prerequisite for employment at CHDI Management.
Job Description
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 managing projects in the clinical portfolio (including, but not limited to clinical studies and trials). This detail-oriented, self-starting individual will work closely in a team and 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.
Job Responsibilities
A Clinical Research Program Manager will be expected to work closely with project the study teams, Directors and others within CHDI to:
· foster strong relationships with site staff, investigators, and key stakeholders (including CROs
and other external clinical service providers) to promote collaboration and support site success
· manage and drive various aspects of select clinical studies and process improvement projects
· liaise with internal and external stakeholders, such as CHDI legal and finance, other clinical team members, site staff, institutional review boards, etc.
· develop and/or oversee development of other project-related documents including protocols, case report forms, study manuals, SOPs, informed consent forms, monitoring plans, communication plans, tracking tools, and other project tools as needed
· draft, review and negotiate changes in informed consent forms
· evaluate, select, and manage CROs, contractors and other outside vendors
· 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
Qualifications
The successful candidate will have:
· Bachelor’s or Master’s degree in life sciences, healthcare, project management/business, or related field
· experience in pharmaceutical industry/biotech/CRO/academic experience in clinical research project/trial management including budgeting, contracting and study execution is a plus
· proactive, creative problem solving skills and be open to innovative solutions
· high attention to detail and care about the quality of their work
· demonstrated ability to multitask, prioritize responsibilities, and work effectively in a fast-paced environment
· demonstrated ability to work independently in a distributed, interdisciplinary, team-oriented environment
· excellent communication skills
· proficiency and willingness to expand/improve their skills in the following Microsoft applications: Excel, PowerPoint, and Word
· be comfortable in a fast-paced, dynamic environment
· willingness to travel as needed to visit study sites and attend meetings or training sessions
Additional Skills
An ideal candidate might also have:
· knowledge of site management and monitoring processes, and quality assurance procedures
· 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
· certification in clinical research (e.g., CCRA, CCRP)
· experience with ICF negotiations and regulatory document management
· experience working on CNS clinical research or drug development
· experience negotiating vendor agreements
About CHDI Foundation, Inc.
CHDI is a private, not-for-profit research organization. We work with an international network of scientists to discover drugs that slow the progression of Huntington’s disease (HD) and provide meaningful clinical benefit to patients. We seek to accelerate scientific progress by serving as a collaborative enabler. We encourage and support cooperation and collaboration among HD researchers. Our strategy is to encourage researchers to develop practical ideas, useful research materials, and powerful technologies, often by providing financial support.
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.
About CHDI Management, Inc:
CHDI Management, Inc. was established in 2002 to provide administrative, management and grant making services to CHDI Foundation, Inc.
About our Donors
CHDI’s activities focus solely on the identification and development of drugs that delay or slow Huntington’s disease. We are indebted to our donors, whose generosity and guidance have made possible this exclusive focus on science.
Job Type: Full-time
Schedule:
Work Location: Hybrid remote in Princeton, NJ 08540
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