Senior Operations Manager, Clinical Assessment Technologies (US/LATAM)

Requisition Number: 5469

Position Title: Senior Manager Operations, CAT

External 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 3,000 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.  

As an Operations Manager, Clinical Assessment Technologies (CAT), you will

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).

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 sponsor and protocol specifications
• 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
• 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 PowerPoint

 
REQUIREMENTS:

• 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, possesses excellent time management and project management skills and communicate effectively.  
• 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.

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! 

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Employment Type: Regular

Community / Marketing Title: Senior Operations Manager, Clinical Assessment Technologies (US/LATAM)

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.

Location_formattedLocationLong: Raleigh, North Carolina US

CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.