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Operations Manager

2 months ago

Durham, United States Worldwide Clinical Trials - USA Full time
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 you will do

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. (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.

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 www.worldwide.com/careers For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.