IQVIA Principal Clinical Data Manager (Home/Office-Based) - Novella Clinical in Indianapolis, Indiana

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity 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.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled'

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™

At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.

Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.