Clinical Affairs Manager

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 :

Pay range and compensation package

For immediate consideration, please send your resume to Kiara@venturehiregroup.com