Clinical Data Analyst II
Westlake Village, CA
Req ID 48479BR
Business Title
Clinical Data Analyst II
Business
BioScience
Sub-Business
Research & Development
Country
US
State/Province
California
Location of Position
Westlake Village, CA
Shift_
1st
Job Description
The position is responsible for supporting clinical data management (CDM) operational activities in one or more therapeutic areas.
•Support the creation, execution and maintenance of Data Management Plans in support of clinical study deliverables.
•Lead or contribute to the design, creation and lifecycle management of data collection, validation and reporting specifications and usage guidelines.
•Employ standardized electronic and ad hoc reporting tools to review clinical data for consistency with the protocol requirements and good clinical practices.
•Partner with Clinical Operations personnel to manage the query lifecycle.
•Represent CDM in study team meetings and facilitate cross-functional activities (e.g. Clinical Data Listing Reviews).
•Accountable for the delivery of fit-for-use and regulatory-compliant clinical study data. Partner with External Service Providers (ESPs) (e.g. CROs, EDC Vendors, Central Labs) in order to support business goals and further the mission of CDM.
Job Requirements
•Excellent analytical, problem-solving, organizational, time-management, interpersonal and communication skills
•Knowledge of all aspects of the clinical trials process from pre-clinical to post-marketing phases
•Ability to interpret and apply regulatory requirements
•Knowledgeable concerning all aspects of qualification and compliance assessments
•Demonstrated ability to effectively partner with ESPs
•Technical understanding of clinical research technologies and data validation methodologies
•Knowledge of systems integration and data interchange standards
•Proficient in the use of one or more of the leading Clinical Database Management Systems
•Experience supporting continuous process improvement initiatives
•Current with industry developments, trends and opportunities Preferred: BA/BS + 2 years experience or equivalent experience in the Pharmaceutical, Device or Biotech industries (Sponsor, CRO or combination) in roles of increasing responsibility
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
