Associate Director, Clinical Data Manager (Home-Based) - IQVIA Biotech

POSITION TITLE:      Associate Director, Data Management

REPORTS TO:              Director Data Management or Designee

BASIC FUNCTIONS:

Associate Director Data Management position is to direct data management staff to ensure consistency, while ensuring adequate staffing of projects and provide for staff training opportunities.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Data Operations Oversight for Projects/Program:
  • Reviews Metric reports for overall departmental performance
  • Consolidates staffing projections for DM activities for studies
  • Implements process or system improvements for global implementation
  • Discusses roadblocks with PM & management for completing study objectives in a timely manner
  • Reviews project budgets and staffing projections for data operation activities
  • Provides training and guidance for DM staff and DM Leads
• Supervises department staff:
  • Responsible for the hiring, promotion, transfer and release of staff
  • Reviews team member activities to ensure departmental processes are followed
  • Writes and distributes performance reviews to staff members
  • Assigns DM Leads to projects, and team members to DM leads/Principals
  • Trains team members on specific departmental processes (Trial design document creation, Edit Check creation, CCB process, coding, database lock, etc.)
  • Develops, implements, and maintains performance metrics and measures of capacity
  • Approves timesheets for direct reports
  • Ensures training is documented effectively
  • Oversees staff adherence to corporate policies
• Publicizes Data Management:
  • Presents to clients and other interested individuals about Data Operations (New Hire Orientation, Kick-off meetings, bid defense, corporate lessons learned, etc.)
  • Reviews budgets and proposal texts for data management activities.
• Creates and Maintains Documentation for departmental standards:
  • SOPs and/or WPs
  • Creates or Modifies Templates for the Data Management Plan, CRF Completion Guidelines, Trial Design Document, edit specifications, reconciliation guidelines, report specifications, etc.

KNOWLEDGE, SKILLS AND ABILITIES:

• Ability to lead departmental team members
• Ability to collaborate with management and answer questions related to general DM concerns
• Ability to maintain positive and open relations with corporate peers
• Ability to facilitate team meetings and take meeting minutes
• Good working knowledge of clinical trials data processing concepts
• Ability to create DM study documents (CRF guidelines, trial design document, edit check specifications, data review plan, etc.)
• Ability to perform research for data collection and protocol specific topics
• Good presentation skills

• Proficiency with multiple data management processing systems (preferred systems are InForm, Rave, and Oracle Clinical)

• Proficiency of IQVIA Biotech SOPs, WPs for general and DM operations
• Prioritization and organizational skills to meet or exceed customer expectations
• Ability to update timelines using time management tools (@Task, MS Project, etc.)
• Organized and thorough with attention to details
• Highly-Effective interpersonal skills and excellent communication skills, verbal, written and listening
• Ability to learn new things and teach others
• Ability to accept constructive criticism
• Ability to adhere to and create detailed instructions
• Effective logical thinking ability regarding Problem-solving skills
• Proficiency in computer applications (Windows, Excel, Word, Outlook, etc.)
• Team leader

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Very little physical effort required to perform normal job duties (unless otherwise indicated)
• Travel, as required for office visits, bid defenses, Investigator Meetings, or other meetings as requested.

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 7 years in data management, and
• 5 years supervisory experience.

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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.

In compliance with the Colorado Equal Pay For Equal Work Act, salary range is displayed - Salary Pay Range: $107,300 - $145,000