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 [email protected]

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