Manager, Clinical Assessment Technologies Operations

Who we are

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 over 3,500+ 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.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

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 multipl