Clinical Project Manager (100% Remote)
Location: Saint Louis
Posted on: May 15, 2022
100 % REMOTE
This Jobot Job is hosted by Juan Correa
Are you a fit? Easy Apply now by clicking the "Apply" button and
sending us your resume.
Salary $125,000 - $225,000 per year
A Bit About Us
We are a clinical-stage biopharmaceutical company that discovers,
develops and seeks to commercialize next-generation therapeutics
for diseases representing significant unmet medical needs and
burden to society, patients, and their families. Our current
pipeline focuses on the central nervous system, respiratory, and
Why join us?
Medical Benefits (Medical, Dental, Vision, 401K Plan)
Manages clinical projects from concept through clinical study
report completion in line with company, Good Clinical Practice,
regulatory, standards, and compliance requirements.
Achieves study objectives by developing project priorities, setting
milestones, and resolving project conflicts.
Assesses the operational feasibility of studies and recommends
execution and risk mitigation plans.
Prepares study-related documents, including protocols, protocol
amendments, informed consent forms, patient questionnaires,
monitoring plans, trial master files, case report forms and other
Prepares IRB submissions and address IRB questions.
Develops, track, and manages study timelines, budget, and study
Works with legal team to facilitate the preparation of clinical
trial agreements, non-disclosure agreements, consultant agreements,
vendor agreements and other contracts.
Ensures appropriate clinical resources are available for the
Leads investigator/site staff meetings and site trainings.
Manages clinical research study conduct and ensure it is in
compliance with GCP and regulatory requirements.
Participates in CRO, consultant and other vendor selection,
negotiation, and management of the contract, including monitoring
of associated budgets and payment of invoices.
Select study investigators, screening sites and evaluate adequacy
to perform research and meet study timelines.
Responds promptly and appropriately to study questions and issues
raised by investigative sites, vendors, monitors, and
Ongoing analysis of study enrollment to ensure goals are on
Participates in the analysis, summary, and reporting of clinical
data through the course of the study.
Review serious adverse events and other pertinent data with the
company endodontists, medical advisors and regulatory to identify
safety trends and potential risks.
Review and approve monitoring reports and confirm that appropriate
conclusions and actions are taken for significant findings.
Identifies and communicates trial issues that will impact budget,
resources and/or timelines to management.
Implement best practices, processes, and technology to optimize all
aspects of data collection and maintain data quality and data
integrity, including standardization of data elements and entry of
information into databases.
Maintains professional expertise through familiarity with
therapeutic area and clinical research literature.
Ability to prioritize multiple tasks and achieve project
Education And/or Work Experience Requirements -
Bachelor of Science in a health-related field and/or equivalent
qualification and experience
5-10 years of clinical research experience including a minimum of
2-5 years as project-lead or Clinical Research Associate
Interested in hearing more? Easy Apply now by clicking the "Apply"
Keywords: Jobot, St. Louis , Clinical Project Manager (100% Remote), Healthcare , Saint Louis, Missouri
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