Prevail InfoWorks ยท 3 weeks ago
Associate Director, Clinical Data Management
United States
Full-time
Remote
Lead/Staff, Director/Executive
10+ years expPrevail InfoWorks focuses on eClinical technology products including Clinical Data Integration and Data Analytics. They are seeking an Associate Director for their Clinical Data Management team to oversee data management projects and ensure quality and compliance.
AnalyticsInformation ServicesPharmaceuticalSoftware
Hiring Manager
Madeline Ward
Responsibilities
Participates in development, review, and revision of departmental procedural documents
Provides training for DM staff
Evaluates departmental practices with a focus on continual process improvement from a analytical and data quality stand point
Participates in evaluation and application of DM resource allocation
Oversees project EDC releases to ensure release requirements are met (standard reports, alert management, site and user activation and training, DM data review tools etc.)
Other duties assigned by Director, Information Data Management
Define eCRF specs from a protocol
Build eCRFs in EDC
Define and build data set specs
Define edit checks/validation specs
Write and execute data management plans
Clean and query data, and manage site/CRA follow up
Manage reconciliations with external data such as labs and IRT
Define listings and reports for technical staff in terms of clinical data set variables
Development of DM project activities timelines
Preparation and maintenance of action item logs for DM projects
Development and delivery in data sets in SDTM format
Advocate for greater use of dynamic graph viewer in protocol compliance, data review, and cleaning activities
Maintain awareness of and implement best industry practices per SCDM good clinical data management practices
Qualification
Required
Bachelors degree preferably in the sciences
At least 5 years experience leading DM projects
Minimum of 10 years experience in clinical research as a Clinical Data Manager or Clinical Research Associate
Direct experience with hands on building EDC and validation check configurations
Great communications skills, both verbal and written, remotely and in-person
Organized and detail-oriented for improving data management processes
Ability to work as a team for organizational success
Experience in clinical research, biotechnology and/or healthcare industry required
Experience with the following eClinical product areas: Data Integrations, Data Analytics, eDC, Safety, eTMF, RTSM/IxRS, CTMS, or Investigator Grant Management
Proficiency with Microsoft Office Tools (Excel-Spreadsheets, Word, PowerPoint)
Company
Prevail InfoWorks
Prevail InfoWorks is a system integration and analytics software company.
51-200 employees
H1B Sponsorship
Prevail InfoWorks has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2021 (1)
Funding
Current Stage
Growth StageLeadership Team
Jack Houriet
Chief Executive Officer
Recent News
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