Patient Screening Specialist

Overview

Position Title: Clinical Affairs Manager (Case Review Board)

Level: Individual Contributor

Work Setting: Remote

Position Summary:

Reporting into the Senior Director of Clinical Affairs, this role oversees global case planning activities within clinical trials. The position partners closely with both internal teams and external collaborators-including Field Clinical Specialists, site-level Research Coordinators, imaging core labs, and the Case Review Board-to build, execute, and refine CRB-related processes. In addition to individual contributions, this role supports cross-functional teams and provides guidance to less experienced Clinical Affairs staff.

Key Responsibilities

• Coordinate and manage the scheduling and facilitation of Case Review Board (CRB) meetings, partnering with committee members and clinical site providers across multiple studies.
• Lead the preparation and alignment of subject case presentation materials in collaboration with clinical trial sites.
• Partner with cross-functional stakeholders to streamline and standardize workflows, improving the efficiency of case planning activities.
• Develop, review, and finalize CRB presentation content alongside clinical research coordinators, implanting physicians, and field clinical personnel.
• Act as a liaison with investigators and study coordinators regarding case determinations, scheduling, required testing, and exclusions.
• Establish and maintain CRB governance documents, including charters and process frameworks.
• Oversee imaging data workflows, ensuring proper upload, transfer, and issue resolution.
• Collaborate with clinical sites and imaging core labs to optimize patient screening from initial submission through final approval for treatment.
• Create, refine, and implement standard operating procedures supporting CRB-related processes.
• Serve as the primary subject matter expert for patient screening workflows during clinical study initiation phases.
• Maintain accurate tracking systems, including case logs, enrollment tools, and status reporting.
• Monitor and manage existing proctor agreements, while working with contracting teams on new agreements to support expanding studies.
• Oversee relevant activities within electronic data systems tied to clinical trial enrollment and tracking.
• Provide mentorship and developmental guidance to junior Clinical Affairs team members.
• Perform additional responsibilities as needed.

Qualifications

Education & Experience

• Minimum of 5 years of experience in clinical operations, including areas such as site management, patient screening, or case planning (medical device experience preferred).
• Strong proficiency in Microsoft Office applications, particularly PowerPoint and Excel.
• Experience leading or supporting virtual meetings using platforms such as Microsoft Teams or Zoom.
• High degree of accuracy and attention to detail.
• Demonstrated ability to engage effectively with stakeholders at all organizational levels.
• Capability to work both independently and collaboratively within team environments.
• Experience managing or developing team members is preferred.
• Advanced degree in a life science discipline, pharmacy, or nursing is advantageous.

Core Competencies

• Solid understanding of clinical trial operations, including patient screening and case review processes.
• Familiarity with regulatory and compliance standards such as Good Clinical Practice (GCP), EU Medical Device Regulation (MDR 2017/745), ISO 14155, and ICH guidelines.
• Proven experience in process design, optimization, and continuous improvement initiatives.
• Ability to collaborate effectively within cross-functional teams in a fast-moving medical device environment.
• Self-directed, well-organized, and capable of managing multiple priorities while maintaining high-quality output.
• Strong communication skills, both written and verbal, with the ability to influence stakeholders across functions and geographies.
• Comfortable working within highly integrated team structures and dynamic project environments.
• Availability to work within Pacific Standard Time (PST) business hours.