Manager, Central Rating

That’s why we’re seeking a Manager, Central Rating accountable for overseeing clinicians and associates responsible for administering telehealth assessments and questionnaires to clinical trial participants. This role ensures the smooth execution of decentralized clinical trial (DCT) activities through leadership and operational oversight. Key responsibilities include supervising central rater team members and proactively addressing challenges related to remote assessments—such as scheduling, patient engagement, and technology issues (e.g., telehealth and data collection platforms). The manager will drive continuous improvement, foster innovation, and champion process excellence to enhance both patient experience and data quality. This position requires compliance with Good Clinical Practice (GCP) and regulatory guidelines to ensure accurate, complete clinical data collection. By promoting collaboration and effective communication among internal teams, patients, and stakeholders, the manager will support the successful achievement of clinical trial objectives and the delivery of high-quality remote assessment services.

Key Responsibilities

• Supervise a team of clinical staff responsible for conducting patient assessments over the phone and collecting clinical data.
• Oversee staff performance, provide regular feedback, and ensure team members follow standard protocols and regulatory requirements.
• Foster a positive and collaborative team environment, supporting both professional development and patient-centric care.
• Support the implementation and design of effective remote assessment workflows for clinical assessmentsWork alongside IT and technical support teams to troubleshoot and resolve technical issues encountered during remote assessment sessions, ensuring minimal disruption to patient care.
• Ensure that remote assessments are conducted in compliance with clinical trial protocols and regulatory guidelines, such as FDA regulations and ICH-GCP standards.
• Monitor patient engagement during remote assessment sessions to ensure active participation and accurate data collection.
• Ensure all required assessments, data collection and documentation are completed in a timely manner, supporting ongoing clinical trial needs..
• Support efforts in monitoring audit-ready documentation practices for telehealth sessions and assessments.
• Ensure accurate reporting to internal and external stakeholders on service delivery and progress.
• Support remote assessment best practices and recommend improvements to increase efficiency and patient satisfaction, while maintaining regulatory compliance. Proactively managing risks with the team.
• Collaborate with cross-functional teams to establish and refine processes for remote patient assessments, ensuring processes align with operational needs, data management protocols and industry standards.
• Maintain accurate and updated standard operating procedures (SOPs) for remote assessments, patient follow-ups, and documentation of clinical trial data.
• Oversee direct reports deliverables and ensure they meet study requirements and timelines.

Requirements

• Bachelor’s degree in Life Sciences, Healthcare, Nursing, or a related field. Advanced degrees (e.g., MS, RN) or certifications (e.g., CCRA, CCRP) are a plus.
• Minimum of 5 years of experience in the pharmaceutical or clinical research industry, with at least 2 years of experience in a management or supervisory role leading clinical research coordinators (CRCs) or similar roles.
• Experience with clinical trial protocols, GCP, and regulatory compliance (e.g., ICH-GCP, FDA, HIPAA).
• Familiarity with DCT operational models, telehealth technology and their application in clinical research is strongly preferred.
• Experience with clinical data management systems and electronic health records (EHR).
• Experience in clinical research protocols involving older adult and/or cognitively impaired populations preferred.
• Experience with process development.

Skills, Knowledge and Specialist Expertise

• Proven leadership and management experience, including the ability to mentor and develop staff.
• Strong knowledge of clinical trial processes, data collection, and regulatory standards.
• Familiarity with telehealth technologies and platforms, and ability to optimize remote clinical assessments.
• Excellent interpersonal, communication, and problem-solving skills.
• Strong organizational and time-management abilities, capable of managing multiple priorities and ensuring project timelines are met.
• Excellent problem solving/decision making skills/Anticipates problems and develops recommendations for management resolution
• Comfort with ambiguity and uncertainty  

What’s In It For You

• Remote Work Practices: Cogstate is a virtual first company. Cogstate employees can work from anywhere where Cogstate is registered to business within the United States, Australia, or the United Kingdom!
• Generous Paid Time-off: Cogstate employees receive 20 days of vacation leave, 10 days of personal leave and 10 paid public holidays.
• 401(k) Matching: As you invest in yourself and your future, Cogstate invests in you too: we match up to3% of your yearly salary in Cogstate’s 401k program.
• Competitive Salary: We offer competitive base salaries plus additional earning opportunities based on the position.
• Health, Dental & Vision Coverage: We've invested in comprehensive health & dental insurance options with competitive company contributions to help when you need it most. We also offer free vision insurance for all full-time employees.
• Short-Term & Long Term Disability Life Insurance: 100% employer sponsored
• Pre-Tax Benefits: Healthcare and Dependent Care Flexible Spending Accounts
• Learning & Development Opportunities: Cogstate offers a robust learning program from mentorships to assistance with programs to improve knowledge or obtain certifications in applicable areas of interest.