ResearchEd

Clinical Research

• Review, understand, and assess clinical data before it is reviewed by Medical/Client.
• Communicate and present the relevant trends and findings of the clinical review to the Study Team and the Client.
• Ensure that the clinical database and regulatory projects maintain the highest level of integrity.
• Collaborate with the Client, subcontractors, and Catalyst assigned Study Team members to meet project timelines and Client expectations for the clinical data review.
• Assist in the review of CRFs, data quality review plans, and other clinical study reports.
• Propose methods to improve collaboration, efficiency, and excellence in data-related review deliverables to the Chief Scientific/Medical Officer, Clinical Operations and Biometry.

Clinical Scientist

Manager

• Responsible for the oversight and performance of Clinical Monitoring staff in accordance with internal Key Performance Indicators (KPIs).
• Lead, manage, and motivate a team of Clinical Monitoring staff to a standard consistent with Catalyst’s values and overall focus on quality.
• Develop evaluation processes, perform gap analysis, and ensure all clinical staff are properly trained to perform their duties consistent with Catalyst’s quality standards.
• Perform CRA assessment visits on-site or remotely to assess and document overall CRA performance.
• Work in collaboration with Clinical Monitoring Leadership to define department targets for Clinical Monitoring staff and ensure proper monitoring expectations.
• Participate in resource management, including by not limited to Clinical Monitoring staff resourcing to projects, participation in interviewing and hiring decisions and review of utilization and billing practices to ensure resource alignment with project budgets.
• Support the development and maintenance of Clinical Monitoring project deliverables as needed.
• Provide support for site audits/inspections, as needed, and follow audit/inspection findings to resolution as it relates to involved Clinical Monitoring staff.
• Periodic review of Monitoring reports to ensure quality oversight as needed.
• Implement functional standards, goals, and expectations with Clinical Monitoring staff and serve as mentor.
• Ensure training of and compliance with appropriate Catalyst and/or sponsor SOPs.
• Complete Clinical Monitoring staff onboarding and offboarding as appropriate.
• Drive process improvements across Oncology line of the business.
• Other ad hoc responsibilities as required.

Manager, Clinical Monitoring

• Responsible for the oversight and performance of Clinical Monitoring staff in accordance with internal Key Performance Indicators (KPIs).
• Lead, manage, and motivate a team of Clinical Monitoring staff to a standard consistent with Catalyst’s values and overall focus on quality.
• Develop evaluation processes, perform gap analysis, and ensure all clinical staff are properly trained to perform their duties consistent with Catalyst’s quality standards.
• Work in collaboration with Clinical Monitoring Leadership to define department targets for Clinical Monitoring staff and ensure proper monitoring expectations.
• Participate in resource management, including by not limited to Clinical Monitoring staff resourcing to projects, participation in interviewing and hiring decisions and review of utilization and billing practices to ensure resource alignment with project budgets.
• Support the development and maintenance of Clinical Monitoring project deliverables as needed.
• Provide support for site audits/inspections, as needed, and follow audit/inspection findings to resolution as it relates to involved Clinical Monitoring staff.
• Periodic review of Monitoring reports to ensure quality oversight as needed.
• Implement functional standards, goals, and expectations with Clinical Monitoring staff and serve as mentor.
• Ensure training of and compliance with appropriate Catalyst and/or sponsor SOPs.
• Complete Clinical Monitoring staff onboarding and offboarding as appropriate.
• Drive process improvements across Oncology line of the business.

Clinical Operations

• Accountable for the activities of the Asia Pacific team members; managerial responsibilities including interviewing, terminations, training, coaching, performance management, goal setting and salary.
• Perform some or all Project Management responsibilities on key projects as needed to support direct reports and clients.
• Support project activities leading to building client relationships for defined customers and contracts; deliver “The Catalyst impact.”
• Provide input into development of the planning and reporting framework using core systems and internal KPIs; review KPIs to monitor project delivery and client satisfaction.
• Develop SOPs to govern the Asia Pacific function and identify/support development of project-specific SOPs.
• Accountable for the financial management of projects and the Asia Pacific function; provide input into departmental budget, revenue recognition, project profitability, contract scope management and invoicing methodologies.
• Represent Asia Pacific function during QA audits; ensure project and team readiness and complete CAPA responses to identified system/process weaknesses or customer complaints.
• Support Business Development representatives with solutioneering, proposals, bid defense materials, and contracting of new business.
• Other responsibilities and ad hoc projects as required.

Director, Clinical Operations

• Review, understand, and assess clinical data before Medical/Client review.
• Communicate and present relevant trends and findings to the Study Team and the Client.
• Ensure clinical database and regulatory projects (e.g., Clinical Study Reports) maintain the highest level of integrity.
• Collaborate with the Client, subcontractors, and Catalyst assigned Study Team members to meet project timelines and Client expectations.
• Assist in the review of CRFs, data quality review plans, and other clinical study reports.
• Partner with the Study Team in the development of data review plans for individual clinical studies and CRF design.
• Provide continuous review and interpret relevant clinical efficacy and safety endpoint data across listings and visual analytics.
• Participate in tracking/analysis of any potential safety events within a given trial and across trials for assigned program(s).
• Create data summary slides for Safety Review Committee Meetings, DSMBs, and Catalyst Data Review Meetings.
• Create queries on EDC data as needed during Clinical review, provide timely follow up and identify potential protocol deviations.
• Assist in the development of study-specific listings and perform informal UAT testing for project level Clinical analytic dashboards.
• Review and provide input on data driven sections of reporting documents, such as INDs, BLA/NDAs, Annual Report, IBs, briefing books, CSRs, IMPDs, etc.
• Mentor and/or train staff and provide scientific writing for subject/patient narratives or non-regulatory documents such as abstracts, posters, and oral presentations.
• Serve as point of contact for site staff and monitors regarding study protocol and clinical inquiries.
• Fluent in Visual Analytics interpretation.

Clinical Scientist

Manager, Clinical Monitoring

Manager, Clinical Monitoring

Director, Clinical Operations

Associate Clinical Scientist / Clinical Scientist