IQVIA Senior Lead Clinical Data Manager (Home/Office-Based) - Novella Clinical in Boulder, Colorado
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: 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
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.
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.