What the Operations Manager does at Worldwide

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).

What you will do

• 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
• Other Clinical Assessment responsibilities
• 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. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

What you bring to the role

• 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

Your experience

• 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)
• The role requires domestic and international travel to attend key meetings. The global nature of the position may also require the incumbent to manage their time flexibly on occasion to be responsive to stakeholders in different time zones

Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.