Senior Clinical Data Manager - United States
- We are seeking a full-time Senior Clinical Data Manager for our Data Management team.
- This person will provide comprehensive data management expertise and manages end-to-end delivery of data management services.
- Responsible for the integrity of the data entered into a company CRF/eCRF and database.
- Ensures database is complete, accurate and consistent and meets quality standards required by Sponsors and regulatory bodies.
- Collaborates and participates in multidisciplinary teams involved in setting up, running and reporting clinical trials.
- Responsible for Sponsor contact, project communication and timeline management for all data management functions.
- Manages, organizes and processes clinical data using a range of computer applications and database systems and processes (EDC and paper-based) to facilitate collection and cleaning of subject data.
Leading Studies/Programs – Manages clinical data management activities for assigned studies/programs in accordance with company SOP's, policies and practices.
QC Functions – Using Edit Checks, Data Listings and other available tools/reports, manage Quality Control of data to ensure accurate, complete data is provided according to study timelines and contract described deliverables.
Management of CRFs – Oversee CRFs from the creation of the blank CRF through delivery of final CRF to sponsor.
Data Cleaning and Delivery – Manage clinical data cleaning and delivery activities up to and including database lock.
- Bachelor degree in Business, Science or related field or a combination of education and relevant data management pharmaceutical industry experience
- Minimum 7-10 years data management experience required, 4-5 years of which should be direct CDM Lead experience.
- Knowledge of Good Clinical Data Management Practices, CDASH/CDISC, SDTM, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 required
- Knowledge of SAS and SQL required
- Knowledge of paper, EDC, and hybrid-base data collection and processing, as well as experience with multiple CDMS/e-clinical systems; strong technical skills
- Ability to create, review, and revise CDM training materials, SOPs, and process/procedural guidelines
- Ability to manage multiple projects/program priorities required
- High attention to detail required
- Excellent oral and written communication skills required
- Excellent organizational and presentation skills required
- Proficiency in MS office applications required