Operations Manager, Clinical Assessment Technologies

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. [SH1]

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 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 SOPs and ICH/GCP/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 communicating 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
• Organize the timely completion of editing / 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 provide reports to the study team and Sponsor
• Provide necessary CAT data to ensure comprehensiveness of CAT’s Final Study Report

What You Will Bring To The Role

• Highly organized, detail- and service-oriented
• Excellent planning, managing, monitoring, scheduling, and critiquing skills
• Excellent at meeting timelines consistently and being able to effectively work under pressure
• Continuously open to constructive, developmental feedback
• Strong writing and verbal communication skills in order to clearly and concisely present information

Your Experience

• Bachelor’s degree, in Life Science preferred
• Two to four years of experience working in clinical trials
• Demonstrable knowledge of operational aspects regarding Phase I-IV clinical research trials Ample knowledge of SOPs and ICH/GCP/regulatory guidelines
• Competency working with data and numbers
• The role requires travel domestically and internationally in order to attend key meetings. The global nature of the position may also require the incumbent to occasionally manage their time flexibly in order to be responsive to stakeholders in different time zones.

Why Worldwide

At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you – committed to advancing science and moving mountains for our customers.

Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!