Description
- Establish and guard study timelines and Data Management Plans that address areas such as data coding, reporting, or transfer, database locks, and work flow processes.
- Design and validate forms, and clinical databases including testing logic checks.
- Process clinical data including receipt, entry, verification, or filing of information.
- Perform quality control audits to ensure accuracy, completeness, or proper usage of clinical systems and data.
- Supervise the work of data management project staff to ensure clinical data reporting and analysis is done appropriately/compliant with SOP's.
- Coordinate data management activities to ensure timely database lock and release of data for interim and final analyses.
- Perform patient outcomes analysis and resolution of measurements issues associated with device trials
- Utilization of advanced statistical software packages including SAS, SPSS, and M-Plus.
- Experience with data manipulation, editing, imputation, analysis, interpretation, and reporting.
- Knowledge of efficient strategies for analysis of large data sets, including techniques for merging datasets from diverse sources. Thorough understanding of statistical methods including logistic regression, multiple regression & trend analysis.
- Assist with selection and evaluation of research locations
- Assist with the development of research protocols and SOP's/documents, such as CRF, data capture guidelines, publications and clinical rapports.
- Prepare and implement data specific training programs and materials for internal staff
- May act as a cross-functional liaison to ensure study plan aligns with business development strategies
- Perform other duties as assigned (i.e. preparation of status reports, as required)
- Collaborate cross-functionally to produce study publications.
Required Skills
ESSENTIAL QUALIFICATIONS (essential functions of position):
- Minimum of 5 years Data Management experience required, minimum 2 year supervisory experience.
- Knowledge of clinical database design and remote data entry technology
- Strong knowledge of ICH-GCP
- Regular attendance is required
NONESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS (not necessary but preferred):
Statistics or Health Outcomes BA/BS degree (or equivalent relevant knowledge e.g. nursing qualification
- 2+ experience with clinical database systems such as EDC, preference for Oracle Clinical.
- Experience with CDISC/CDASH and standard coding dictionaries (e.g., MedDRA)
- Experience writing scientific manuscripts for peer-reviewed journals
SUPERVISORY RESPONSIBILITIES:
Will oversee Clinical Data Associates
To find out more about Real please visit www.realstaffing.com