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Senior Clinical Data Manager Remote United States,
Posted on : 14 June 2017
- 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
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