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Clinical Trial Project Manager

United States, United States · Healthcare
JOB TITLE:           Clinical Trial Project Manager
REPORTS TO:      Vice President of Operations and Product
STRUCTURE:       Full Time, Salaried
LOCATION:          Remote
FIVOS, Inc. provides technology and services for the healthcare industry to manage clinical information and utilize it to improve patient care quality and reduce costs. Powered by our advanced technological infrastructure and years of experience working in a regulatory environment, FIVOS is the leader in enterprise healthcare management solutions. 

Our company supports medical society quality improvement registries that collect real-world data that can be used to evaluate devices and medications. Current registries include the Vascular Quality Initiative (VQI) and the Neurovascular Quality Initiative (NNVQI), which focus on the treatment of peripheral and intracranial vascular disease. Data from these registries have been used to create multiple device evaluation projects required by manufacturers for regulatory purposes, including post-approval surveillance, label expansion, EU MDR requirements, objective performance goals, and control cases for new device comparison.  These activities often require the collection of additional data beyond the standard registry, provided through supplementary contracts with registry sites and custom data elements added to the registries.  We’re currently looking to add a new Clinical Trial Project Manager to the team.

The Clinical Trial Project Manager will manage/oversee the conduct and execution of assigned clinical trials and associated activities in accordance with Good Clinical Practices (GCP) and relevant national and international requirements.

  • Assist with the review and determination of appropriate site selection and trial design/timelines.
  • Interacts with internal and external groups (Medical Societies, working groups, steering committees, vendors, clinical sites, etc.) to facilitate clinical trials and achieve designated timelines.
  • Oversees study timelines, clinical trial budgets, coordinates development of study plans, CRF's and other study reports and reviews and approves monitoring reports as appropriate. Develop and track operational monitoring and budgetary reports.
  • Oversees and participates in review of clinical trial data and clinical trial files. Provides clinical review of operational and payment and budgeting reports.
  • Participates in periodic review and revision of departmental policies and SOPs to assure compliance with GCP and corporate policies.
  • Participates in special projects as appropriate.
  • Maintains professional clinical and technical knowledge by staying current on pharmaceutical and medical device industry research and developments as appropriate; by utilizing the resources made available by the Company; and by sharing information with colleagues.
  • Keeps management informed by escalating issues requiring intervention to the study and project teams under the supervision of the VP of Operations and Product Development.
  • Create materials for, lead and support project/trial meetings. 
  • Lead internal and external training, project kickoff and status webinars.
  • Attend Medical Society regional group and annual meetings.
  • Provide product development, project/trial and clinical support to internal departments.
  • Bachelor's degree from a four-year university or college
  • 3+ years’ work experience in the healthcare or clinical trial industry monitoring and managing clinical trials; or equivalent combination of education and experience.
  • Possesses a fundamental understanding of clinical development principles, theories and concepts and knowledge of pharmaceutical/medical device industry practices and standards, including GCP.
  • Familiarity with the lifecycle of a clinical trial: from protocol development and feasibility through study close-out and reporting.
  • Working knowledge of relational databases and data warehouse technologies and at least one EDC system or registry platform a plus
  • Knowledge of SQL, Oracle APEX, and data analysis tools (R, Python, SAS, SPSS, or equivalent) a plus.
  • Knowledge of BI Tools (Looker, Tableau, Microsoft Power BI, or equivalent) a plus
  • Ability to manage multiple complex and global clinical trials.
  • Ability to balance multiple priorities across studies and programs.
  • Must have experience managing early phase trials. 
  • Experience with vascular and neurovascular imaging.
  • Excellent written and oral communication skills.
  • Ability to communicate in medical and scientific terms with vendors, consultants, and peers.
  • Ability to read, analyze and interpret professional journals, technical procedures, and/or government regulations.
  • Ability to write reports, business correspondence and procedure manuals.
  • Ability to effectively present information and respond to questions from groups of managers, sites, medical societies, steering committees, working groups etc.
  • Ability to solve problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Must have demonstrated ability to work independently and in a team.
  • Ability to manage time, multi-task and prioritize to complete deliverables on schedule.
  • Experience with post approval studies and clinical registries a plus.
  • Experience with the Society for Vascular Surgery VQI or SNIS NVQI registries a plus.
  • Excellent knowledge of business applications, Microsoft Office, and Google Workplace (G-Suite) tools required.

We recognize that talented people are attracted to companies that provide competitive pay, comprehensive benefits package and outstanding advancement opportunities. For this reason, we offer a comprehensive benefits plan that includes the following:
  • 401K and Company match
  • Medical coverage
  • Dental coverage
  • Vision Coverage
  • Paid time-off
  • Flexible spending accounts
  • Employee life insurance
  • Disability insurance
FIVOS is an Equal Opportunity Employer

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