Clinical Affairs Manager

About the CompanyImmediate Opening for a Clinical Affairs Manager(Medical Device)About the RoleAre 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.ResponsibilitiesDrive 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 packagePaid Time Off (PTO)401(k)Medical, dental, and life insuranceAnnual performance bonusFor immediate consideration, please send your resume to Kiara@

Created: 2025-10-01