We believe in finding you a better way.

Senior Clinical Data Manager

Data ScientistData ScientistFull TimeRemoteTeam 501-1,000Since 1997H1B No SponsorCompany Site LinkedIn

Location

Florida

Posted

151 days ago

Salary

$79.0K - $140K / year

Bachelor Degree6 yrs expEnglishGoogle Cloud Platform

Job Description

• Act as the primary liaison for data management deliverables on assigned studies. • Provide senior-level guidance and support to the Data Managers team across multiple large-scale studies. • Supervise the preparation of data collection forms, database design, specification and testing, cleaning, locking, extracting, and reporting on study progress for internal and external stakeholders. • Collaborate with clinical research, data managers, and other internal teams, focusing on continuous process enhancement, issue resolution, workload forecasting, and technical consultation. • Participate in data management strategies for regulatory and marketing initiatives. • Lead data management efforts for internal and outsourced studies. • May manage staff responsible for performing those activities. • Lead data management activities, including creation of data management plans and data review plans (DMP & DRP), as well as training materials. • Lead development and review of SOPs, work instructions, and associated documents for CDM. • Creates and enforces processes for effective database build and data management in EDC, CTMS, ePRO and eTMF systems. • Support the development of study-specific database builds using study protocol and configuration specifications. • Is compliant with project and data management plans for data handling and sharing with the clinical research team. • Oversees/Performs User Acceptance Testing (UAT). • Support the clinical research team and sites in the daily use of data systems and ensures adherence to legal and company standards. • Facilitate stakeholder training of data management systems. • Lead manual listing review activities according to the DMP and DRP. • Manage ongoing query review with closures of system-generated queries according to the DMP and DRP. • Lead the distribution of data reports, extracts, and other deliverables as defined in the data management plan. • Conduct data management meetings and provide clinical team updates regarding data listings, issues, cleaning, and locking. • Lead and coordinate the creation of study-specific eCRF Completion Guidelines. • Assures databases and archives are protected from security breaches and losses. • Manage troubleshooting activities for data-related problems. • Manage clinical data cleaning and delivery activities, including database lock.

Job Requirements

Bachelor's degree required.
Preferably in Business, Life Science, or Computer Science.
Master's degree preferred.
Preferably in Business, Life Science, or Computer Science.
At least 6 years of clinical data management experience is required.
3 years of that time as a study lead role preferred.
Clinical Data Management certification (i.e. CCDM) is preferred.
Must be obtained within 1 year of hire if not already held.
Demonstrate knowledge of ICH/GCP guidelines as they relate to data management is required.
Demonstrate knowledge of ISO standards preferred.
Demonstrate knowledge of FDA Regulations related to data handling and processing, which is required.
A thorough understanding of CDISC CDASH and SDTM standards is preferred.
Prior trial responsibility of the entire data management lifecycle is required.
Experience working with medical device trials is preferred.
Knowledge of EDC and Clinical Data Management Systems required.
Comprehension of medical terminology or reference literature for understanding is required.
Proficiency in Microsoft Office Applications, specifically in MS Excel, is required.
Experience in vendor oversight is preferred.
Experience in leading or mentoring clinical data teams is preferred.