Durham, North Carolina, USA
1 day ago
Manager, Clinical Assessment Technologies Operations

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 Clinical Assessment Technologies Department does at Worldwide 

Clinical Assessment Technologies (CAT) is a team of highly experienced clinicians and operations experts whose purpose is to improve clinical outcomes data by reducing data variability associated with lack of training, inconsistent approaches to scale administration and scoring, placebo response, and incorrect source. The members of CAT have extensive industry-related experience stemming from their time working on the site level for sponsors and other service providers. Additionally, the CAT team has conducted more than 75 international Phase I to Phase IV trials and has trained over 7,000 raters. 

What you will do 

•    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 li censes, 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 and Other Clinical Assessment Responsibilities

•    Management of Operations staff, as assigned
 
What you will bring to the role 

•    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

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, 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.

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.
 

Exact compensation may vary based on skills, experience, and location:

$86,765.00 - $172,235.00

We love knowing that someone is going to have a better life because of the work we do. 

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

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