POSITION TITLE: Senior Manager, Data Management
REPORTS TO: Director/Associate Director, Data Management or Designee
BASIC FUNCTIONS:
Manager Data Management position is to oversee data management staff to ensure adequate staffing of projects as well as adequate training of staff.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Data Management Oversight for Projects/Program:
Reviews Metric reports for overall departmental performance
Reviews staffing projections for DM activities for studies
Implements process or system improvements for global implementation
Discusses roadblocks with PM & data operations management for completing study objectives in a timely manner
Reviews project budgets and staffing projections for data management 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, change control process, database lock, etc.)
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 data management 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 documents, 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
Efficiency 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 communications 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
8 years of experience in pharmaceutical industry and/or contract research organization, with 7 years in data management, and
5 years as a Lead Data Manager, and
4 years supervisory experience.
CLASSIFICATION:
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com
