Senior Project Manager

Company: ICON Strategic Solutions
Location: Cheyenne
Posted on: May 27, 2023

Job Description:

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
The Sr Project Manager (Sr. CTM) is responsible for oversight, coordination, and execution of clinical trials in support of clinical programs in Phases I-IV of development
Duties and Responsibilities:

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  Clinical project team member: works closely with the Clinical Program Manager and is responsible for leadership, oversight, planning, and execution of assigned clinical studies, timelines, and key deliverables.
  
  
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  Works closely with Clinical Outsourcing on selection of CROs and vendors, RFI, RFP and bid defenses, and co
  
  
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  Oversees and works directly with CROs, vendors, field monitors and other partners. Establishes and maintains strong relationships with investigators, study coordinators, site personnel and other external key stakeholders.
  
  
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  Accountable for developing and managing study budgets and financial reporting, including month end and quarterly flash reporting, financial reconciliation, accruals, and re-forecasting, with Clinical Outsourcing, Finance and Project Management.
  
  
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  Responsible for study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects.
  
  
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  Works with Patient Recruitment department and is responsible for overall recruitment strategy, enrollment projections, and meeting established targets.
  
  
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  Oversees and/or participates in development of clinical study documents including ICF, monitoring plans, recruitment plans, and other program/study related documents.
  
  
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  Leads and participates in internal cross-functional clinical team meetings; serves as main point of contact for study-level status updates.
  
  
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  Presents at management meetings, clinical team meetings and other forums on study progress.
  
  
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  Works with Study Start-up and coordinates study start-up activities including feasibility, investigational product and materials preparation, trial master file setup, CRFs, regulatory documents, and site contracts in conjunction with other relevant departments.
  
  
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  Participates in database creation and user acceptance testing, provides input for edit checks, monitoring guidelines, and data cleaning activities between study sites, data management and field monitors.
  
  
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  Participates in SOP development, process mapping, training of junior CTMs and CTAs, and other departmental activities.
  
  
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  Direct line management and supervision of CTMs and/or CTAs. Responsible for performance reviews and supporting professional development for direct reports.
  
  
  Education and Skills required:
  
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    8 years of relevant experience
    
    
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    Minimum 5 years of experience in clinical research, including a minimum of 2 years full service project management experience or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.
    
    
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    Reads, writes and speaks fluent English; fluent in language of host country.
    
    
    Preferred Education and skills:
    
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    • BA/BS or equivalent is preferred with a minimum of 8 years of pharmaceutical or biotech research
      
      Benefits of Working in ICON:
      Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
      At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
      ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
      If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
      #LI-MH3
      #LI-Remote

Keywords: ICON Strategic Solutions, Cheyenne , Senior Project Manager, Executive , Cheyenne, Wyoming