Clinical Project Manager (100% Remote)

Company: Jobot
Location: Saint Louis
Posted on: May 15, 2022

Job Description:

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 metabolic diseases.

Why join us?

Professional Development
Medical Benefits (Medical, Dental, Vision, 401K Plan)
Holidays
Vacation
Life Insurance

Job Details

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 study tools.

Prepares IRB submissions and address IRB questions.

Develops, track, and manages study timelines, budget, and study metrics.

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 clinical project.

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 consultants.

Ongoing analysis of study enrollment to ensure goals are on target.

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 timelines.

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 experience.

Interested in hearing more? Easy Apply now by clicking the "Apply" button.

Keywords: Jobot, St. Louis , Clinical Project Manager (100% Remote), Healthcare , Saint Louis, Missouri