Operations Manager, Clinical Assessment Technologies (US/Remote)

Location: Morrisville, North Carolina, United States

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Requisition Number: 1066

Position Title: Manager, Clinical Assessment Technologies Operations

External Description:

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

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.

#LI-HD1 

City:

State: North Carolina

Employment Type: Regular

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

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: Morrisville, North Carolina US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

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© Worldwide Clinical Trials 2019

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.