Manager, Clinical Assessment Technologies Operations
About The Position
The Operations Manager has primary responsibility for overseeing the operational work related to rater selection, rater certification/qualification, rater training content, scale acquisition, surveillance maintenance, and workbook/source document management for Worldwide Clinical Trials, Inc. (Worldwide). The Operations Manager is responsible for ensuring all assigned projects are conducted in a timely fashion and in a manner compliant with Standard Operating Procedures (SOPs), International Council for Harmonization/Good Clinical Practice (ICH/GCP), and regulatory guidelines. The Operations Manager works under the direction of the Operations Director, Clinical Assessment Technologies (CAT).
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 to clearly and concisely present information
- Strong interpersonal skills in a fast-paced, deadline-oriented, and changing environment
- Strong ability to handle multiple tasks and administrative details in a fast-paced and constantly changing environment
- Strong self-motivation skills
- Strong ability to work in teams
- Excellent proficiency in all Microsoft Office applications, including 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, the individual must demonstrate a strong ability to lead, understand policies and procedures, financial and leadership principles, possess excellent time management and project management skills, and communicate effectively
- Demonstrable knowledge of operational aspects regarding Phase I-IV clinical research trials and ample knowledge of Standard Operating Procedures (SOPs), International Council for Harmonization/Good Clinical Practice (ICH/GCP), and regulatory guidelines
- Competency working with data and numbers
- Fluency in English (will be required to write, speak, and understand English to conduct day-to-day business)
Responsibilities
- Coordinate completeness of rater experience qualification documents and communicate collection results to the Sponsor and study team
- Develop study-specific rater training web portals and ensure readiness based on study timelines
- Coordinate logistical matters of the Investigators’ Meetings and associated CAT materials; manager may attend such meetings
- Organize the timely completion of editing and formatting of didactic training presentations
- Oversee scale and study source workbook management by obtaining scale licenses, translations, regulatory authorizations, and Sponsor approvals
- Oversee data surveillance methodology maintenance by tracking and reconciling incoming source documentation and providing reports to the study team and Sponsor
- Provide necessary CAT data to ensure comprehensiveness of CAT’s Final Study Report
- Oversee archiving of all CAT study documents
- Consult on rater training and data surveillance plans to ensure documents represent Sponsor and protocol specifications
- May develop and present at Sponsor Kick-Off Meetings regarding CAT operations work
- Work with the Operations Director and Worldwide Clinical Trials study team to ensure study budgetary demands are met
- Manage Operations staff, as assigned
- Perform other duties as assigned.
Benefits
- Competitive benefits package depending on location
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What This Job Offers
Job Type
Full-time
Career Level
Manager
