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- Columbus, OH
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Senior Lead Clinical Data Manager (Home/Office-Based) - IQVIA Biotech
IQVIA • Columbus, OH
Posted 30 days ago
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: Lead Clinical Data Manager
REPORTS TO: Associate Manager/Manager, Director Data Management
Lead Clinical Data Manager position is to manage all data management tasks from project start-up to database lock, to produce a clean and analyzable database.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Manages a data management project
- DM lead for internal/client team meetings and communication
- Produces and Reviews Metric reports for internal/external project team
- Ownership for project deliverables within DM scope of services including projections
- Discusses roadblocks and solutions for completing project objectives in a timely manner
- Reviews project budgets and staffing projections for data management activities
- Provides training of other DM staff on project specific processes
- Clinical Data and Query Review
- Creates the Data Review Plan and the DM listings using ad hoc query tools
- Issues queries and review query responses with the highest level of quality based upon the Data Review Plan, Aggregate Checks (DM listings), Reconciliation (LAB, SAE, ECG), other reviewers (Biostatistician, Medical Monitor, Client), and ad hoc reports
- Oversees System Development and Modifications:
- Drafts the CRF design, edit check specification and DM listings
- Facilitates clinical team review of system documents (CRFs, Edit Checks, Data Review Plan, etc)
- Consolidates comments from internal team/sponsor for discussion and approval
- Ensures all non-DM activities related to database development are completed in a timely manner
- Manages all database modifications for DM activities.
- Validation Creation:
- Oversees the entry of data in the Development or QC systems that will be 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 requests.
- Provides feedback to the other project team members and managers to improve the deliverables.
- Creates and Maintains Documentation for the project
- Data Management Plan along with supporting DM documents, such as CRF Completion guidelines, Data Entry guidelines, Trial Design Document, Edit specifications, Reconciliation guidelines, and Report specifications.
- Project Specific SOPs/WPs (as directed by PM)
KNOWLEDGE, SKILLS AND ABILITIES:
- Team player with ability to learn new things and teach others
- Ability to work well with technical and clinical team members and collaborate with entire clinical team (CRAs, Safety, Bios, etc) and maintain positive and open relations with internal, sponsor, and vendor team members
- Ability to facilitate team meetings
- Knowledge of clinical trials concepts
- Ability to create detailed DM project instructions and documents (CRF guidelines, trial design document, edit check specifications, data review plan, etc.)
- Proficiency with DBMS processing systems (preferred systems are InForm and Rave)
- Proficiency with Novella SOPs, WPs for general and DM operations
- Efficient with organizational skills to meet deadlines
- Organized and thorough with attention to details
- Effective interpersonal skills and excellent communications skills, verbal, written and listening
- Ability to accept constructive criticism
- Effective logical thinking ability in regards to Problem-solving skills
- Proficiency in computer applications and time management tools (Excel, Word, Outlook, Project, etc.)
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Very little physical effort required to perform normal job duties (unless otherwise indicated)
- Travel up to 40 hours as requested for bid defense meetings, Investigator Meetings, client face-to-face meetings, user group meetings or training courses. Travel not anticipated exceeding 60hrs per year.
MINIMUM RECRUITMENT STANDARDS:
- Bachelor's degree in one of the life sciences, or equivalent knowledge and experience, and
- 7 years of clinical data management experience in pharmaceutical industry and/or contract research organization
This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.
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™
QVIA 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 email@example.com to arrange for such an accommodation.
Job ID: R1061577