Associate Director, Data Management

**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
- 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
- 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.