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: Senior Lead Clinical Data Manager
REPORTS TO: Associate Manager/Manager Director, Data Management or Designee
Senior Lead Clinical Data Manager position is to manage all data management tasks for a program of studies from study start-up to database lock, to produce a clean and analyzable database.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Manages DM Projects/Programs
- DM lead for internal/client team meetings and communication
- Provides Metric reports for internal/external project teams
- Provides staffing projections for DM activities for studies
- Implements process or system improvements for global implementation
- Ownership for project deliverables within Data Management scope of services
- Discusses roadblocks with PM & principal for completing study objectives in a timely manner
- Reviews project budgets and staffing projections for data operation activities
- Provides training of other DM staff on project specific processes
- Clinical Data and Query Review:
- Creates Data Review Plan for studies and develops standards for the Department
- Creates listings using ad hoc query tools
- Oversees the issuing of queries and review query responses with the highest level of quality based upon the Data Review Plan
- Oversees System Development and Modifications:
- Drafts the CRF design, edit check specification and DM listings
- Facilitates clinical team review of system (eCRFs, Edit Checks, and Data Review Plan, etc.)
- Documents comments from internal team and sponsors for discussion and approval
- Ensures all non-DM activities related to database development are completed in a timely manner
- Ensures all database modifications are communicated with team and implemented effectively
- Validation Creation
- Oversees the entry of data in the Development or Quality Control systems used for validation.
- Assists with the validation of CRF system (CRF content & edit checks), Reports using EDC Reporting and/or J-Review, and associated change control.
- Provides feedback to other project team members and managers to improve the deliverables.
- Creates and Maintains Documentation for studies/programs/departmental standards:
- DMP (along with supporting DM documents), CRF Completion guidelines, Trial Design Document, Edit specifications, Reconciliation guidelines, Report specifications
- Project Specific SOPs/WPs (as directed by PM) or Department Forms/Templates for SOPs/WPs
KNOWLEDGE, SKILLS AND ABILITIES:
- Ability to lead DM team members and work well with technical and clinical team members
- Ability to collaborate with entire clinical team (CRAs, Safety, Biostatisticians, etc) and answer questions related to specific data collection concerns
- Ability to maintain positive and open relations with internal, sponsor, and vendor team members
- Ability to facilitate team meetings ensuring accurate attendees and take meeting minutes
- Excellent knowledge of clinical trials data processing concepts
- Ability to perform research for data collection and protocol specific topics
- Proficiency with multiple DBMS processing systems (preferred systems are InForm and Rave)
- Proficiency with Novella SOPs and WPs
- Organized and thorough with attention to details
- Effective Interpersonal skills and excellent communications skills, verbal, written and listening
- Ability to learn new things and teach others
- Ability to accept constructive criticism
- Effective logical thinking ability in regards to Problem-solving skills
- Proficiency in computer programs or time management tools (Excel, Word, @Task, MSProject, etc.)
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Very little physical effort required to perform normal job duties (unless otherwise indicated)
- Travel, occasional as required for bid defenses, Investigator Meetings, or other meetings as requested, not anticipated to exceed 80hr per year.
MINIMUM RECRUITMENT STANDARDS:
- Bachelor's degree in one of the life sciences, or equivalent knowledge and experience, and
- 7 years of experience in pharmaceutical industry and/or contract research organization, with 5 years in data management, and
- 2 years as a Lead Data Manager.
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
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.
Job ID: R1080395