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Principal Clinical Data Manager

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: Principal Data Manager

REPORTS TO: Associate Director/Director, Data Management or Designee

BASIC FUNCTIONS:

Principal Data Manager position is to oversee data operations tasks for a team of data managers from study start-up to database lock, to produce a clean and analyzable database.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Data Operations Oversight for Projects/Program
    • Data Operations lead for internal/client team meetings and communication
    • Provides Metric reports for internal/external project teams
    • Provides staffing projections for DM activities for studies
    • Develop or Propose process or system improvements for global implementation
    • Ownership for specific project deliverables within DM and Project Programming scope of services
    • Discuss roadblocks and solutions with PM and data operations management for completing study objectives in a timely manner
    • Review project budgets and staffing projections for DM activities (including coding)
  • Supervise daily team member activities:
    • Serve as a team leader
    • Review team member activities and deliverables to ensure plans and processes are followed
    • Review with the DM project leads team member allocation to projects to ensure projects and budgets are managed effectively
  • Oversee System Development and modifications:
    • Review the CRF design, annotated CRFs, edit check specification and DM listings
    • Assist other DMs to facilitate clinical team review of system and/or specifications (Online Screen Review, Edit Check Review, Data Review Plan review, etc.)
    • Ensure all non-DM activities related to database development are completed in a timely manner
    • Ensure all database modifications are communicated with team and implemented effectively
    • Review database developments to ensure standard implementations across studies
  • Oversee Database lock activities:
    • Facilitate final team review of data and review documentation for database locks
    • Ensure comments from internal/sponsor for discussion are documented
    • Ensure all non-DM activities related to database lock are completed in a timely manner
  • Data Operations Mentor:
    • Create and Maintain documentation for templates (DMP, CRF Completion guidelines, Trial Design Document, Edit specifications, Reconciliation guidelines, Report specifications)
    • Train others on specific departmental processes (Trial design document creation, Edit Check creation, change control process, database lock, etc.)
    • Provide open environment for question/issues about DM topics


KNOWLEDGE, SKILLS AND ABILITIES:

  • Ability to lead technical and clinical team members
  • Ability to collaborate with entire clinical team (CRAs, Safety, Biostatistics, etc)
  • Ability to maintain positive and open relations with internal, sponsor, and vendor team members
  • Ability to facilitate team meetings and take meeting minutes
  • Excellent knowledge of clinical trial data processing concepts
  • Proficiency with multiple data collection systems (preferred systems are InForm and Rave)
  • Ability to maintain timelines using time management tools (@Task, MSProject, etc.)
  • Effective Interpersonal skills and excellent communications skills, verbal, written and listening
  • Ability to learn new things, teach others, and accept constructive criticism
  • Ability to create and adhere to detailed instructions
  • Effective logical thinking ability in regards to Problem-solving skills
  • Proficiency in computer applications (Windows, Excel, Word, Outlook, etc)


CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very little physical effort required to perform normal job duties (unless otherwise indicated)
  • Travel, occasional 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
  • 10 years of experience in pharmaceutical industry and/or contract research organization, with 6 years in data management, and
  • 4 years as a Lead Data Manager.


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: R1083489

Principal Clinical Data Manager

Columbus, OH
Full Time

Published on 09/10/2019