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Clinical Affairs Manager

Clinical Affairs Manager

Venture Hire Group LLCIrvine, CA, US
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Job Description

About the Company

Immediate Opening for a Clinical Affairs Manager(Medical Device)

About the Role

Are you someone who thrives in a fast-paced, hands-on clinical planning environment? Are you passionate about working with internal and external stakeholders to support the success of global clinical trials? We're seeking a driven, skilled Clinical Affairs Manager who leads the case review board process and works with junior team members to deliver on ongoing clinical programs.

Responsibilities

  • Drive scheduling and executing of meetings with committee members and site-level health care providers across all clinical trials.
  • Oversee the training / coordinating of subject presentation materials for case review board meetings with clinical trial sites.
  • Collaborate with cross functional team leaders to ensure harmonization of processes and practices for case planning efficiency.
  • Preparation and review of presentation materials for meetings for all clinical trials with site clinical research coordinators, implanters, and field clinical specialists.
  • Communication with clinical research coordinators and investigators on case approvals, scheduling, lab work, and excluded cases.
  • Develop and maintain the CRB charters as needed.
  • Manage and troubleshoot imaging upload and transfer workflow.
  • Partner with clinical sites and core lab(s) to manage and improve subject screening workflow from initial submission to final approval of inclusion for treatment.
  • Development, review, optimization, and implementation of standard operating procedures related to case review board workstream.
  • Serve as the primary point of contact and subject matter expert for patient screening process during study start-up.
  • Maintain and optimize case / subject logs, tracking tools, and regular progress reporting.
  • Maintain, track, and update existing proctor agreements and partner with the contracting team on any new contracts required for expanded trials.
  • Manage and maintain relevant electronic data management platform activities related to clinical trial enrollment.
  • Mentor and provide leadership to team members.

Experience & Qualifications :

  • 5+ years of relevant professional experience in clinical operations, site management, case planning, patient screening, etc. is required (preferred in medical devices).
  • Strong background in Microsoft Office Suite, especially PowerPoint and Excel.
  • Experience facilitating Zoom or Microsoft Teams meetings.
  • Strict attention to detail.
  • Ability to interact professionally with all organizational levels.
  • Pay range and compensation package

  • Paid Time Off (PTO)
  • 401(k)
  • Medical, dental, and life insurance
  • Annual performance bonus
  • For immediate consideration, please send your resume to Kiara@venturehiregroup.com

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