Sr Manager Clinical Data Management
Sr Manager Clinical Data Management
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Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Provides input into the design of data flow across EDC and nonEDC data sources across vendor network
- Manages data management service providers to ensure the quality of deliverables and that timelines are met
- Develops and contributes to the design of processes enabling nearrealtime data access for clinical trials
- Ensure data quality of clinical database through the implementation of CDISC compliance.
- Reviews and critically assesses data query resolution metrics and suggests process improvement.
- Reviews study protocols to ensure that data collection and CRF design meet study objectives.
- Manages and oversees SAE and external vendor reconciliation between clinical and applicable databases.
- Review clinical data for completeness accuracy and consistency in accordance with the investigational plan.
- Provide subject matter expertise to project team members during all phases of the project life cycle.
- Provides accurate and timely clinical data to internal and external customers upon request.
- Manage development test and maintain data management systems
- Support the development and periodic review of Data Management specific SOPs WIs and templates.
- Provide subject matter expertise prior during and post internal and external audits and inspections.
- Maintain compliance with company and studyspecific learning requirements
Requirements:
- Bachelors or higher in science math or computer science.
- 5 years experience in data management in the clinical trial industry (med device pharma or biotech).
- Experience with Oncology or rare disease clinical trials and CDISC therapeutic area standards.
- Experience with management of data flow and curation of biomarker data.
- Experience managing Data Management CROs and vendors.
- Relational database experience SAS and clinical data management systems
- Knowledge of CDISC/SDTM. Handson experience preferred
- Handson experience working with mainstream EDC systems (e.g. Rave Medrio)
- Familiarity with Data Visualization Tools for quick customized data access (e.g. Tableau RShiny) is a plus.
- Indepth understanding of Data Management regulatory guidelines: ICH GCDMP 21CFR Part 11.
- Demonstrated strong management abilities for project and staff management of Data Management Deliverables in clinical development.
Employment Type
Full Time
