Manager Operations, CAT

Location: Morrisville, NC, USA

Notice

This position is no longer open.

Requisition Number: 2775

Position Title: Manager, Clinical Assessment Technologies Operations

External Description:

SUMMARY: 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. (WCT). 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).
RESPONSIBILITIES:
Tasks may include but are not limited to:
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;
manager may attend such meetings
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
Oversee archiving of all CAT study documents
Consulted on rater training and data surveillance plans to ensure documents represent

Other Clinical Assessment Responsibilities
May develop and present at sponsor Kick-Off-Meetings regarding CAT operations work
Work with Operations Director and WCT study team to ensure study budgetary demands are
met
Management of 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.
OTHER SKILLS AND ABILITIES:
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
Job Description 

Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
Strong ability to handle multiple tasks and many administrative details in a fast-paced and
constantly changing environment
Strong self-motivation skills
Strong ability to work in teams
Excellent proficiency in all MS-Office applications including Microsoft Word, Excel, Adobe, and
P o w e r P o i n t
REQUIREMENTS:
Preferred minimum of Bachelor’s (life sciences) degree preferred
At least 4+ years clinical trial experience
Preferred at least 1 year of experience managing team members
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
Fluency in English (will be required to write, speak, and understand English to conduct
day-to-day business)
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.

#RC-LI1

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Employment Type: Regular

Community / Marketing Title: Manager Operations, CAT

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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© Worldwide Clinical Trials 2023

We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.