Manager, Clinical Assessment Technologies Operations

This is a fully remote position, open to applicants in United States, +47 more locations.

📋 Description

• Supervise all operational activities concerning rater selection, certification/qualification, training content, scale acquisition, surveillance upkeep, and management of workbooks/source documents.

• Ensure that all assigned projects are conducted in a timely manner, adhering to SOPs, ICH/GCP, and regulatory standards.

• Coordinate the completeness of rater experience qualification documents and relay results to Sponsors and study teams.

• Create study-specific rater training web portals and ensure their readiness aligns with study timelines.

• Organize Investigators’ Meetings along with related CAT materials.

• Manage the editing and formatting of didactic training presentations.

• Oversee the management of scales and study source workbooks, including licenses, translations, regulatory approvals, and Sponsor endorsements.

• Maintain data surveillance methodologies by tracking and reconciling source documentation and generating reports.

• Provide CAT data for Final Study Reports.

• Supervise the archiving of CAT study documents.

• Offer consultation on rater training and data surveillance strategies.

• Develop and deliver presentations at Sponsor Kick-Off Meetings regarding CAT operations.

• Collaborate with the Operations Director and study team to satisfy budgetary requirements.

• Manage designated Operations staff.

• Perform additional duties as assigned.

⛳️ Requirements

• Highly organized, detail-oriented, and focused on service.

• Exceptional skills in planning, managing, monitoring, scheduling, and critiquing.

• Proven ability to consistently meet deadlines and perform effectively under pressure.

• Open to constructive and developmental feedback.

• Strong writing and verbal communication abilities.

• Excellent interpersonal skills in a dynamic, deadline-driven environment.

• Able to manage multiple tasks and administrative details efficiently.

• Highly self-motivated.

• Strong teamwork capabilities.

• Advanced proficiency in Microsoft Word, Excel, Adobe, and PowerPoint.

• Bachelor’s degree in Life Science preferred.

• Two to four years of experience in clinical trials.

• Minimum of two years in a team management or leadership role; in the absence of direct management experience, a demonstrated understanding of policies, procedures, financial and leadership principles, time management, project management, and effective communication is required.

• Demonstrable knowledge of Phase I-IV clinical research trials.

• Significant understanding of SOPs, ICH/GCP, and regulatory guidelines.

• Competency in working with data and numerical information.

• Fluency in English is required for daily business operations.

• Willingness and capability to travel both domestically and internationally.

• Flexibility to work across different time zones as needed.

🏝️ Benefits

• Competitive benefits package based on location.

• An inclusive and equitable workplace.

• Transparent compensation structure.

• Commitment to pay equity and transparency.