Operations Manager, Clinical Assessment Technologies (Remote)

Worlwide Clinical Trials Morrisville , NC 27560

Posted 3 days ago

Join us at Worldwide as an Operations Manager and be part of our unique CRO! This role is full time, permanent and home based anywhere in the United States.


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. (WCT). 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:

  • 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 CATs 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:

  • Preferred minimum of Bachelors (life sciences) degree preferred
  • Previous years clinical trial experience
  • Preferred experience 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.
  • Experience of eCOA or EPRO
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Operations Manager, Clinical Assessment Technologies (Remote)

Worlwide Clinical Trials