Manager, Clinical Assessment Technologies Operations

Worldwide Clinical Trials Holdings, Inc.; North Carolina; On-site; USD 90,000 - 178,000; Full time

Benefits offered by this job

Competitive benefits package

Job summary

Worldwide Clinical Trials, Inc. is seeking an Operations Manager to oversee rater selection, certification, training content, scale acquisition, surveillance, and workbook/source document management across CAT projects.

The role ensures all assigned trials adhere to SOPs, ICH/GCP, and regulatory guidelines, under the direction of the Operations Director. Strong leadership and organizational skills are essential for success in a fast-paced, global environment.

Qualifications

• Bachelor’s degree in Life Science preferred.
• Two to four years of experience in clinical trials.
• At least two years of experience managing a team.
• Familiarity with SOPs, ICH/GCP, and regulatory guidelines.
• Fluency in English (written and spoken).

Responsibilities

• Coordinate completeness of rater experience qualification documents and communicate results to Sponsor and study team.
• Develop study-specific rater training web portals and ensure readiness based on study timelines.
• Coordinate Investigators’ Meetings logistics and CAT materials.
• Oversee editing and formatting of didactic training presentations.
• Oversee data surveillance methodology maintenance and reporting.

Skills

Highly organized

Planning & scheduling

Communication skills

Team collaboration

Proactive problem solving

Education

Bachelor’s degree in Life Science

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Adobe

Job description

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 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 and Evaluation

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.

Salary and Benefits

At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates): United States of America - $90,000.00 - $178,000.00 The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage. We love knowing that someone is going to have a better life because of the work we do.

About Us

Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn. This is who we are. We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.