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Manager, Clinical Assessment Technologies Operations
Posted 2 weeks ago
About the role
- Managing rater training, clinical assessment data, and study operations for Worldwide Clinical Trials, a global CRO. Overseeing compliance, documentation, budgets, and assigned Operations staff.
Responsibilities
- Oversee operational work related to rater selection, certification/qualification, training content, scale acquisition, surveillance maintenance, and workbook/source document management
- Ensure assigned projects are timely and compliant with SOPs, ICH/GCP, and regulatory guidelines
- Coordinate completeness of rater experience qualification documents and communicate results to Sponsors and study teams
- Develop study-specific rater training web portals and ensure readiness to study timelines
- Coordinate Investigators’ Meetings and associated CAT materials
- Organize editing and formatting of didactic training presentations
- Oversee scale and study source workbook management, including licenses, translations, regulatory authorizations, and Sponsor approvals
- Maintain data surveillance methodology by tracking and reconciling source documentation and providing reports
- Provide CAT data for Final Study Reports
- Oversee archiving of CAT study documents
- Consult on rater training and data surveillance plans
- Develop and present at Sponsor Kick-Off Meetings regarding CAT operations
- Work with the Operations Director and study team to meet budgetary demands
- Manage assigned Operations staff
- Perform other duties as assigned
Requirements
- Highly organized, detail-oriented, and service-oriented
- Excellent planning, managing, monitoring, scheduling, and critiquing skills
- Excellent at meeting timelines consistently and effectively working under pressure
- Continuously open to constructive, developmental feedback
- Strong writing and verbal communication skills
- Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment
- Strong ability to handle multiple tasks and administrative details
- Strong self-motivation skills
- Strong ability to work in teams
- Excellent proficiency in Microsoft Word, Excel, Adobe, and PowerPoint
- Bachelor’s degree in Life Science preferred
- Two to four years of experience working in clinical trials
- At least two years of experience managing team members or leading a team; in lieu of people management experience, demonstrated ability to lead and understand policies, procedures, financial and leadership principles, time management, project management, and effective communication
- Demonstrable knowledge of Phase I-IV clinical research trials
- Ample knowledge of SOPs, ICH/GCP, and regulatory guidelines
- Competency working with data and numbers
- Fluency in English required for day-to-day business
- Willingness and ability to travel domestically and internationally
- Ability to work flexibly across different time zones when required
Benefits
- Competitive benefits package depending on location
- Inclusive and equitable workplace
- Transparent compensation
- Pay equity and transparency
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