Manager, Clinical Assessment Technologies Operations (Remote anywhere in United States)

Requisition Number: 433

Position Title: Manager, Clinical Assessment Technologies Operations

External Description:

Worldwide is a global leader in CNS clinical research with unrivaled experience. From psychiatry and neurology to analgesia and addiction drug development, our expertise spans translational medicine through registration studies and peri-approval activities including registries and other observational research that  have a pharmacoeconomic intent. Whether a compound is an original small molecule, injectable large molecule or a bioequivalent generic—our neuroscience experts are true specialists.

Worldwide Clinical Trials is currently hiring a Manager, Clinical Assessment Technologies Operations. The person in this role 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.

The Manager, Clinical Assessment Technologies Operations 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. 
 
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 Clinical Assessment Technologies (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  
• Consult on rater training and data surveillance plans to ensure documents represent Sponsor and protocol specifications 
• May develop and present at sponsor kick-off meetings regarding CAT operations work
• Work with Operations Director and Worldwide Clinical Trial’s study team to ensure study budgetary demands are met
• Management of assigned staff

 
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:

• 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.

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.
 
Worldwide Clinical Trials is an Equal Opportunity Employer

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Employment Type: Regular

Community / Marketing Title: Manager, Clinical Assessment Technologies Operations (Remote anywhere in United States)

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: Research Triangle Park (RTP), 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.