Senior Manager, Clinical Data Avanir Pharmaceuticals
THIS JOB HAS EXPIRED Job Summary
The Senior Clinical Data Manager will provide leadership and comprehensive data management expertise in the development and maintenance of data collection tools and processing of clinical in support of scientific, clinical, regulatory and commercial goals.
Oversee Functional Service Provider (FSP) in data validation engagement to ensure clinical data are processed according to the Data Review Guidelines (DRGs) and Standard Operating Procedures (SOPs).
Design and Implement Electronic Case Report Forms.
Develop data management QC plans and quality control checks for the processing of clinical data.
Develop and maintain the following documents for the clinical database in Electronic Data Capture (EDC); database specifications, data validation (edit checks) specifications, report specifications and other functional specifications.
Create User Acceptance Test (UAT) Plans, Test Scripts and execute testing.
Create transformation rules and mappings for the transition of clinical data between databases (if needed).
Collaborate with a highly motivated and experienced data management team on process improvement and implementation of new technology.
Collaborate with data management peers to coordinate and develop operational reports to assist with data exploration and metrics.
Participate and take leadership role for data management in project team meetings.
Work with Electronic Data Capture (EDC) vendors and project field team to troubleshoot database bugs/issues, to resolution.
Bachelors degree in statistics, information technology or related field.
8 + years clinical data management experience in the pharmaceutical industry
8+ years of hands-on Electronic Data Capture (EDC) experience
Proven experience with the implementation of industry data standards (CDISC, CDASH and SDTM)
Proven ability and prior exp developing reports using SAS, SQL and/or Ad-Hoc Reporting Tools (BO)
Experience with writing SOPs, Work Instructions, Data Management Plans and Guidelines
Ability to juggle multiple tasks and priorities
Analytical and problem-solving skills, with good attention to detail
Excellent communication skills (oral and written) and interpersonal skills
Ability to thrive in a fast-paced environment with a sense of urgency and commitment to meet deadlines
Expert user level for the following software programs: Visio, MS Word, MS Project, MS Excel
||101 Enterprise |
Aliso Viejo, CA 92656
THIS JOB HAS EXPIRED