Relationship Site Manager (2 positions: East and West Coast Regions)

The Regional Site Manager (RSM) reports to and works with the Director of Clinical Operations to provide a high-touch service to clinical study investigators and site research teams.   This is accomplished through ongoing engagement for Eidos clinical trials with a purpose of proactively increasing study and data quality and proactively identifying and mitigating operational risks. The RSM is a critical role in keeping the study “top of mind” with our key sites.  The RSM will continually look for opportunities to optimize the execution of the study(ies) in such a way as to ensure robust protocol adherence, GCP compliance and high-quality data collection in a timely manner. The RSM is one of the Sponsor representatives point-of-contact for the Principal Investigators and all clinical site research staff team members

Job Duties:

  • Site Engagement
    • Serve as one of the key Eidos contact for assigned investigative site staff
    • Ongoing evaluation of enrollment status by site to ensure they are meeting expected enrollment goals
    • Ongoing evaluation of patient compliance and patient study completion
    • Assisting the study centers and CRO with “trouble shooting” site start-up, specialty training (intensive training for e.g. 6MWT, QoLsadministration, EDC, IXRS, and Safety Reporting) as needed.
    • Any pre siteselection activity to identify new study sites or replacement sites.
    • Assist with study entry or study conduct requests
    • Periodically conduct Site Management Calls:
      • Discussions will be based on study and site needs
  • Study Management
    • Development of vendor oversight plan and reports
    • Participate in CRA project-specific training as needed
    • Conduct Monitoring Oversight Visits to evaluate vendor conduct and site conduct of active Eidos sponsored studies
    • Review study start-up and initiation activities in conjunction with the assigned CRO
    • RSMs will complete site oversight reports to assess CRO CRA quality
    • Answer Study Related Questions/Issues and track other FAQs to be shared with the study teams
    • Assist with Data Entry and Query Resolution Support
    • Provide Reports periodically to identify outstanding issues
    • Assist with safety reporting follow up on SAE or AEs of significance
  • As Needed assist Clinical Operations Team with:
  • Track SIVs, IMVs, and COVs as performed by the assigned CRO
  • Review site visit reports as needed
  • Protocol, SOP and Form Development
  • Assist with Clinical Study Document Development (e.g. Study Procedure Manuals, Pharmacy Manual, Site Manual)
  • Listing Review and QC of data
  • Vendor selection, review of RFPs and SOWs
  • Review vendor and site invoices for accuracy

Job Requirements:

  • Excellent relationship-building skills including:
    • ability to gather relevant information and facts in order to make informed decisions and accurate assessments
    • likeable, diplomatic and polished manner
    • effective communication skills, both written and oral
    • ability to work effectively in a matrixed team structure and across organizations (Inter-departmentally within the site, CRO, Sponsor, and our third partyservice partners)
  • Collaborative, high energy personality with positive, “can-do” attitude
  • Service-oriented
  • Creative and flexible problem solver
  • Proactive nature
  • Highly organized

Essential Requirements:

  • Position will work remotely, with occasional onsite meeting attendance
  • Able and willing to travel 50-80% of the time
  • Must have a valid driver’s license
  • Must have a valid passport

Preferred Education, Experience and Skills:

  • Bachelor’s degree in a scientific discipline or equivalent is required; an advanced degree is preferred.
  • Minimum of 8 years of biotechnology and/or pharmaceutical industry clinical research experience with at least 3 years overseeing and managing clinical trials, CROs, and third-party clinical service providers.
  • Experience with Microsoft Office Suite required (Word, Excel, Project, Outlook).

 

Qualified candidates, please apply directly via: https://bridgebio.workable.com/jobs/929206