Analyst, Warehouse Data
Bring people, processes, technology together to generate business value. Contribute to clinical study life cycle through precision, speed, & innovation. Accountability includes: study start-up, conduct & close-out support through system specification, data review, and query management; providing key technology & process support to internal personnel and investigative sites with the goal of optimizing our eClinical system and process portfolio, which includes RAVE Electronic Data Capture (EDC), Interactive Response Technology (IRT) and electronic Patient Reported Outcomes (ePRO); providing global sample management support for Pharmacokinetics (PK), Pharmacodynamics (PD) and Pharmacogenetics (PG) samples with an emphasis on planning, standardization and production throughput; and finally, bringing clinical trial data into internally-developed clinical databases to present data in a usable format for Global Pharmaceutical R&D (GPRD) data reviewers and for analysis by Statistical Sciences.
Key Responsibilities Include:
Key Responsibilities Include:
- Uses data models and data structures based on appropriate industry standards for clinical trials.
- Ensures consistent data structures are available across clinical trials as appropriate.
- Programs data edit checks, under supervision, used in execution of clinical data cleaning plans. Programs data review tools, under supervision, used for clinical data review.
- Performs integration of clinical data from desperate data sources, for clinical trials, using Extract Transform and Load (ETL) tools.
- Supports the execution of all Data and Statistical Sciences (DSS) processes involved in the locking of the clinical trial.
- Changes data models and structures in support of post-production change activities.
- Actively collaborates with other DSS functions. Liaises with the DataAnalysts, Testing Specialists, Statistical Programmers, and Statisticians. Effectively communicates progress of database definition and development.
- Identifies needed updates to design specifications, clinical trial application interfaces, data models and data structures.
- Escalates data model, data structure and/or database issues to Data Analysts, Testing Specialists, Statistical Programmers and/or Statisticians as appropriate
- Bachelor's (Master's preferred) Degree in Management Information Systems, Computer science, Life Sciences or equivalent.
- 2+ years of experience with clinical database design, data loading, and implementation.
- Experience with data modeling concepts.
- Demonstrated intermediate SQL and PL/SQL programming skills.
- Experience with data integration using ETL tools.
- Experience using analytical tools.
- Good understanding of clinical data management
- Good understanding of FDA expectations and guidelines related to applications used in clinical research.
- Strong data analytics experience as well as ability to understand and examine the data.
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Creates a learning environment, opens to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality. Demonstrated effective communication skills.
- Learns fast, grasps the 'essence' and can change the course quickly where indicated. Raises the bar and is never satisfied with the status quo