
Principal Study Build Programmer
- Bangalore, Karnataka
- Permanent
- Full-time
- Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components
- Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives
- Provide insights into study level deliverables (i.e. Data Management Plan, Project Plan, database, and observed datasets)
- Support submission, inspection and regulatory response activities
- Lead cross Business Unit/Therapeutic Area projects or programs with high complexity
- Develops and tests new ideas and/or applies innovative solutions that create value to the portfolio
- Increase speed, accuracy, and consistency in the development of systems solutions
- Enable metrics reporting of study development timelines and pre and postproduction changes to database
- Partner with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Management Associate to deliver study database per business need and before first patient visit
- Comply with and influence data standard decisions and strategies for a study and/or program
- Utilize therapeutic knowledge and possess a deep understanding of the technology used to collect clinical trial data
- Effectively apply knowledge of applicable internal, external and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.) to study build deliverables
- Integrates cross-functional and/or external information and applies technical knowledge to data-driven decision Making
- Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysis
- Represent Data and Analytics processes in cross-functional initiatives
- Actively participate in shared learning across Data and Analytics organization
- Work to Increase re-usability of forms and edits by improving the initial design
- Work to reduce postproduction changes change control process
- Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization
- Interacts with regulators, business partners and outside stakeholders on business issues
- Thinks with end to end in mind consistently managing risk to minimize impact on delivery