Clinical Data Management Associate - Pharmaceutical Industry
Location: San Rafael, CA
Pay Rate: DOE (Shift Differentials Available)
Start Date: 8/31/20
12 Month Contract Role (Potential for extension or conversion)
Department: Clinical Data Management
Job Category: Biometrics
On behalf of our BioPharma industry client we are seeking a 'Clinical Data Management Associate' for a 12 month contract assignment. The Biometrics group is responsible for designing, capturing, analyzing and presenting data that can drive key decisions for Clinical Development, Medical Affairs and other business areas of the company. With a quality-by-design culture, Biometrics builds quality data that is fit for purpose to support statistically sound investigation of critical scientific questions. The Biometrics team develops solid analytics that are visually relevant and impactful in supporting key data driven decisions across the company.
The Data Management Operations team is responsible for the efficient and effective delivery of complete, correct, and consistently fit-for-purpose data sets for statistical analysis across all clinical development and post-approval programs. The team brings a focus on process improvement through innovation and the application of best practices to the oversight and execution of all program-related data management activities such as: protocol review, Case Report Form (eCRF) development, Data Management Plan development, Data Validation Plan development, requirement specifications, reconciliations, and data quality validation activities
The Data Associate / Sr. Data Associate supports Data Management Program and/or Data Management Study Lead in the execution of assigned data management tasks for all study related data management activities including protocol review, eCRF development, Data Management Plan development, Data Validation plan development, reconciliations and the delivery of complete, correct, and consistently fit-for-purpose study data sets for statistical analysis.
- Draft Case Report Form (eCRF) in a concise, self-explanatory, and user-friendly format.
- Collaborate with study team colleagues to ensure eCRF completion guidelines/instruction are accurate.
- Draft Data Management Plan outlining key Data Management activities and deliverables.
- Collaborate with Clinical Programming and Data Quality Science and facilitate the completion of the Data Validation Plan.
- Conduct appropriate ongoing/periodic data validation activities, including reviews of data listings, discrepancies- and the related follow up on management of queries with investigators.
- Draft data transfer specifications.
- Conduct SAE reconciliation activities. Maintain data transfer calendar requirements.
- Post listings/reports/profiles to study file locations.
- Reconcile external data, including drafting data transfer specifications and header data.
- Maintain and track timeline, discrepancies, query resolution, and deliverable status.
- Track data flows and data review status.
- Maintain Trial Master File updates for all data management deliverables
Skills & Education:
- Master’s or bachelor’s degree with a focus in Health Sciences
- 2-5 years of experience in clinical development experience inclusive of technical experience within and outside of Clinical Data Management
- Demonstrates professional maturity, including understanding own strengths and receptivity to feedback
- Demonstrates ability to recognize, understand, articulate, and respond promptly to issues, risks, and opportunities that arise
- Adapts to change by accepting changes in work assignments readily and with an optimistic perspective
- Demonstrates a willingness to be flexible and “do what it takes” to achieve a common goal when change occurs
- Translates objectives into specific plans and creates realistic work schedule before starting work on projects
- Communicates ideas and intentions in a clear, timely, and practical manner
- Understands the basic clinical data management processes, identifies where their work sits within the data management and study/program lifecycle, and is familiar with policies and processes relating to assigned work
- Demonstrates knowledge of key study documents, their key stakeholders, and DM role in managing the development of contents: Data Management Plan (DMP), eCRF, database, validation and transfer requirement specifications, etc.
- Understands basic data validation plans, data quality checking processes, and impact on data sources; identifies and escalates data inconsistencies and errors appropriately
- Demonstrates familiarity with clinical trial data including CRFs, external data, safety data, efficacy data, and endpoints
- Understands the objectives/purpose of each drug development phase (I-IV) and the related key cross-functional deliverables
Please submit your resume in PDF or Word format to be considered
TPS Group LLCThe TPS Group, www.tpsmithgroup.com, is a recruiting and staffing firm that is a trusted recruiting partner to top companies.
San Rafael, CA