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About the Role

The Operations Manager has primary responsibility for overseeing operational work related to rater selection, certification, training, scale acquisition, surveillance maintenance, and workbook/source document management. This role ensures assigned projects are conducted in a timely and compliant manner according to SOPs, ICH/GCP, and regulatory guidelines, working under the direction of the Operations Director, Clinical Assessment Technologies (CAT).

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.
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.

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.
Two to four years of experience working in clinical trials.
At least two years of experience managing team members or leading a team.
Demonstrable knowledge of operational aspects regarding Phase I-IV clinical research trials.
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.

Skills

Microsoft Office
Microsoft Word
Microsoft Excel
Adobe
PowerPoint
Planning
Managing
Monitoring
Scheduling
Critiquing
Meeting timelines
Working under pressure
Constructive feedback
Writing
Verbal communication
Interpersonal skills
Handling multiple tasks
Self-motivation
Teamwork
Project management
Time management

Location

United States of America

Work Type

Domestic travel
International travel

Experience Level

Two to four years of experience working in clinical trials
At least two years of experience managing team members or leading a team

Education Level

Bachelor’s degree in Life Science preferred

Salary/Compensations

$90,000.00 - $178,000.00

Benefits

Competitive benefits package depending on location

About the Company

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.
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!

Equal Opportunity

We ensure pay equity and transparency and comply with all applicable labor laws.