Sr. Clinical Data Analyst

  Independently manage all data management tasks for assigned clinical trials and compounds (drug projects), including interactions with internal and external customers:

-  Develop and/or review data management plans

-  Coordinate and approve development and printing of case report forms

-  Coordinate database setup including edit checks and testing

-  Coordinate non-CRF data collection and format

-  Coordinate database lock activities

-  Coordinate review and feedback process for data transfers and data listings

-  Provide accurate deliverables within timelines established by the study team and project team

-  Review clinical trial documents (e.g., protocols, case report forms, statistical analysis plans, study reports)

? Monitor data processing activities (collection, entry, queries, coding) to ensure quality and timely processing of clinical trial data

? Define and maintain specifications for study and project level database/CRF and data management processes ensuring compliance with company-wide and project level standards

? Complete task designations for vendors via Scope Worksheet and Task Order process; assist in CRO evaluation, selection and management of vendors.

? Represent data management at Investigator Meetings, CRO Meetings and internal team meetings (responsible for presentations and information exchange)

? Comply with all applicable regulatory requirements and company standards and procedures, including documentation of data management activities and archival of study documentation.

 

4 yrs exp. in Data Management preferred - CRO interaction/management - EDC is ideal

Bachelor Degree - Pharma/CRO experience