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).


  • 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
  • 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


  • 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
icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Lead Clinical Data Manager (Home/OfficeBased) Iqvia Biotech (R1077938)

Iqvia Holdings Inc

Posted 3 days ago

VIEW JOBS 10/15/2019 12:00:00 AM 2020-01-13T00:00 Job Description IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. POSITION TITLE: Lead Clinical Data Manager REPORTS TO: Associate Manager/Manager, Director Data Management BASIC FUNCTIONS: Lead Clinical Data Manager position is to manage all data management tasks from project start-up to database lock, to produce a clean and analyzable database. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: * Manages a data management project * DM lead for internal/client team meetings and communication * Produces and Reviews Metric reports for internal/external project team * Ownership for project deliverables within DM scope of services including projections * Discusses roadblocks and solutions for completing project objectives in a timely manner * Reviews project budgets and staffing projections for data management activities * Provides training of other DM staff on project specific processes * Clinical Data and Query Review * Creates the Data Review Plan and the DM listings using ad hoc query tools * Issues queries and review query responses with the highest level of quality based upon the Data Review Plan, Aggregate Checks (DM listings), Reconciliation (LAB, SAE, ECG), other reviewers (Biostatistician, Medical Monitor, Client), and ad hoc reports * Oversees System Development and Modifications: * Drafts the CRF design, edit check specification and DM listings * Facilitates clinical team review of system documents (CRFs, Edit Checks, Data Review Plan, etc) * Consolidates comments from internal team/sponsor for discussion and approval * Ensures all non-DM activities related to database development are completed in a timely manner * Manages all database modifications for DM activities. * Validation Creation: * Oversees the entry of data in the Development or QC systems that will be used for validation. * Assists with the validation of CRF system (CRF content & edit checks), Reports using EDC Reporting and/or J-Review, and associated change control requests. * Provides feedback to the other project team members and managers to improve the deliverables. * Creates and Maintains Documentation for the project * Data Management Plan along with supporting DM documents, such as CRF Completion guidelines, Data Entry guidelines, Trial Design Document, Edit specifications, Reconciliation guidelines, and Report specifications. * Project Specific SOPs/WPs (as directed by PM) KNOWLEDGE, SKILLS AND ABILITIES: * Team player with ability to learn new things and teach others * Ability to work well with technical and clinical team members and collaborate with entire clinical team (CRAs, Safety, Bios, etc) and maintain positive and open relations with internal, sponsor, and vendor team members * Ability to facilitate team meetings * Knowledge of clinical trials concepts * Ability to create detailed DM project instructions and documents (CRF guidelines, trial design document, edit check specifications, data review plan, etc.) * Proficiency with DBMS processing systems (preferred systems are InForm and Rave) * Proficiency with IQVIA Biotech SOPs, WPs for general and DM operations * Efficient with organizational skills to meet deadlines * Organized and thorough with attention to details * Effective interpersonal skills and excellent communications skills, verbal, written and listening * Ability to accept constructive criticism * Effective logical thinking ability regarding Problem-solving skills * Proficiency in computer applications and time management tools (Excel, Word, Outlook, Project, etc.) CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: * Very little physical effort required to perform normal job duties (unless otherwise indicated) * Travel up to 40 hours as requested for bid defense meetings, Investigator Meetings, client face-to-face meetings, user group meetings or training courses. Travel not anticipated exceeding 60hrs per year. MINIMUM RECRUITMENT STANDARDS: * Bachelor's degree in one of the life sciences, or equivalent knowledge and experience, and * 7 years of clinical data management experience in pharmaceutical industry and/or contract research organization CLASSIFICATION: This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation. Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning. IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA's Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation. Job ID: R1077938 Apply Now Not ready to Apply? CHECK OUT OUR SIMILAR JOBS * Data Management Jobs * Data Manager Jobs * Jobs in Durham, North Carolina * Data Management Jobs Durham, North Carolina Iqvia Holdings Inc Morrisville NC

Operations Manager, Clinical Assessment Technologies (Remote)

Worlwide Clinical Trials