PRAHS

  • Oversight Clinical Project Leader - Remote Based

    Job Locations - | US-Remote
    Posted Date 3 days ago(6/15/2018 11:48 AM)
    ID
    2018-47264
  • 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 forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Oversight Clinical Project Lead, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. 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? 

     

    As a Oversight Clinical Project Lead, you will be responsible for oversight of field-based CRAs in a given region (or cross-regionally). Through communications with their assigned CRAs and OCPL Resourcing Manager, the OCPL ensures that adequate resources are available to support the clinical trial monitoring activities planned and/or ongoing at investigational sites.  The OCPL helps to support CRAs to ensure compliance to the various regulatory authorities/ICH/GCP guidelines, and company SOPs. They are responsible for the development of partnerships with various internal and external customers within his/her region and working towards continuous improvement for the CRA and their contribution to the North American Clinical Study Unit.  The OCPL is responsible to ensure on time delivery of milestones and ensure achievement of company and partnership metrics with working alongside the CRM. 

    • Assist in providing overall adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s).
    • Support Project Management and functionally oversee CRAs across all therapeutic areas to ensure business priorities are achieved.
    • Allocates workload to ensure optimal productivity, alignment with the priority projects and optimal usage of RCRA staff. Ensures that monitoring activities within the assigned area are in compliance with GCPs, ICH Guidelines, SOPs and project requirements.
    • Develops and Implements monitoring standards that are consistent across projects and geographic areas.
    • Allocates workload to ensure optimal productivity, alignment with the priority projects and optimal usage of RCRA staff. Ensures that monitoring activities within the assigned area are in compliance with GCPs, ICH Guidelines, SOPs and project requirements.
    • Ensures that monitoring activities within the assigned area are in compliance with GCPs, ICH Guidelines, SOPs and project requirements. Liaises with Clinical Project Leaders (CPL) and Medical Advisors (MAs) to ensure support of project and monitoring activities.
    • Reviews samples of site visit reports with regard to company SOPs and worldwide guidelines for monitoring visit reports. Ensures appropriate training or corrective action as warranted.
    • As part of the overall CPL group - conduct Quality control visits (QCVs) at the request of the project CPL.  Communicates findings to project CPL and other team members and management as appropriate and per SOP instructions.
    • Conduct QCVs when possible for new CRAs or CRAs with any potential quality or milestone deliver concerns. These QCVs can be arranged in conjunction with CPL to account for the QCV study target or can be over the target amount as necessary.  
    • Regular review of study metric reports (Monitoring visits, Monitoring Report Reviews & associated timelines, site specific issues and escalations tracking, site IMPACT compliance) to ensure on time and high quality delivery of studies.
    • Work in conjunction with appropriate vendor Clinical Research Manager (CRM) to address CRA performance concerns.

    Qualifications

    • What do you need to have?

    Education: 

    • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.

    Skills:

    • 3+ years of clinical research experience required
    • Read, write and speak fluent English; fluent in host country language required.
    • 2+ years monitoring experience preferred
    • 6 years of experience in the pharmaceutical industry or clinical-related discipline (e.g. investigative site) including at least 5 years of direct clinical trials experience preferred.
    • 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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