Manager, Clinical Affairs (Case Review Board)

Job Title: Manager, Clinical Affairs (Case Review Board)

Role Level: Individual Contributor

Manager Title: Senior Director, Clinical Affairs

Job Location & Environment: Irvine, CA, Corporate Office

Job Description Summary: Reporting to the Senior Director of Clinical Affairs, the Manager, Clinical Affairs (CRB) will be responsible for case planning for global clinical trials and collaborating with internal and external stakeholders (Field Clinical Specialists, Research Coordinators at investigational sites, imaging core laboratories, and Case Review Board) on CRB process development, execution, and improvement. This position provides leadership junior members of Clinical Affairs and support to multidisciplinary project teams, both internally and externally.

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
• Preparation 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.
• Other duties as assigned.
  
  

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 Required For This Job

• 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.