PRAHS

  • Site Activation Manager- (Home Based)

    Job Locations - | US-Remote
    Posted Date 6 days ago(5/16/2018 1:46 PM)
    ID
    2018-46934
  • Overview

     

    Do you want to watch clinical development change, or do you want to be the one to shape it?

     

    Because we’re hoping you’re here for the latter.

     

    Who are we?

    We Are PRA.

     

    We are 15,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.

     

    Who Are You?

    You are a natural leader with a passion for clinical development. You are organized, but flexible and adaptable to unexpected changes. You can easily envision the bigger picture, without losing sight of the day-to-day tasks. You can provide excellent leadership to not only your project teams, but also to clients. You are excited and enthusiastic. You motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but are always pushing clinical development forward to what it could be. You motivate others to do the same. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

     

    Still here? Good. Because if this is you, we’d really like to meet you.

     

     

    Responsibilities

    What will you be doing?

    Working directly with Investigative Sites, this role will independently manage and perform activities at a site level associated with study start-up including regulatory document collection, preparation of ethics submission documents, informed consent review and essential document package review. Reporting to the Site Activation Strategist, the Start Up Manager must have an in-depth understanding of study start-up activities and associated regulatory requirements.

    • Build, cultivate and manage relationships with key study personnel, including Study Coordinators
    • Work directly with Investigative Sites for all aspects of study start-up including: activation timeline development, regulatory document preparation and collection, IRB/EC submissions and informed consent review
    • Draft and respond to IRB queries and facilitate responses to EC queries
    • Create, review and customization of country/site specific Informed Consent Forms (ICFs)
    • Negotiate site contracts and budgets, as necessary
    • Manage translations of relevant study documents
    • Manage the Clinical Research Organization/Functional Service Provider for outsourced tasks
    • Provide regular local status updates to study team
    • Manage and track issues and escalations to internal stakeholders
    • Develop start-up plans and oversee the execution of plans for assigned sites.
    • Update study-tracking tools and databases with site status
    • Proactively identify site challenges and implement appropriate mitigations
    • Resolve and escalate site issues as appropriate
    • Manage feasibility and/or site identification activities for assigned sites
    • Work directly with key internal personnel to share information, manage and triage issues

    Qualifications

    What do you need to have?

    • Bachelor’s degree with a major in a related field (or equivalent experience) and at least 5 years of experience in study start-up In-depth knowledge of start-up processes and procedures preferred
    • Must have good working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines
    • Experience with investigative site start-up documents
    • Good understanding of clinical trial execution
    • Fluency in English and in host country language
    • ***Experience with Cystic Fibrosis and/or complex therapeutica areas highly preferred***


    Key Competencies Required:

    • Ability to work under pressure to meet deadlines
    • Self-motivated and ability to work well independently and in a team environment
    • Ability to effectively manage multiple priorities
    • Excellent verbal and written communication
    • Excellent project management skills
    • Excellent collaboration skills
    • Meticulous attention to detail and process oriented
     
     
    In addition to experience listed above:
    • Minimum of 8 years prior experience within a clinical role – for example Clinical Operations, Study Start Up, Clinical Team Manager - Highly preferred
    • Undergraduate degree (or its international equivalent - Or equivalent related industry experience) in clinical, science or health-related field from an accredited institution 


    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

     

    To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

     

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