Manager, Clinical Affairs (Case Review Board)

Job Responsibilities

• Drive scheduling and executing CRB meetings with committee members and site-level health care providers across all clinical trials.
• Oversee the training/coordinating of subject presentation materials for CRB meetings with clinical trial sites.
• Collaborate with cross functional team leaders to ensure harmonization of processes and practices for case planning efficiency.
• Prepare and review of presentation materials for CRB 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 junior Clinical Affairs team members through individual development plans and department milestones.

Qualifications

• Required Education and Experience: 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.
• Ability to lead a team and work in a team environment.
• Experience in line management and developing direct reports is strongly recommended.
• Advanced degree in a biological science / pharmacy/ nursing desired.

Skills And Abilities

• Working knowledge of clinical study execution and patient screen / case planning.
• Knowledge of GCPs governing the conduct of clinical trials; working knowledge of Medical Device Regulations 2017/745, ISO 14155 and ICH Guidelines.
• Experience in developing and improving processes.
• Ability to work collaboratively as part of a multi-functional medical device development team in a dynamic environment.
• Must be self-motivated, highly organized, detail-oriented and able to multi-task, delivering high quality work.
• Demonstrated ability in oral and written communication skills; excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally.
• Ability to work in a fast-paced work environment within a cross-functional and highly interdependent team structure.
• Ability to work pacific standard time hours.