- Program and test data collection systems for a trial or set of trials within a program using data standards library
- Ensure data collection systems 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
Project Management
- Increase speed, accuracy, and consistency in the development of systems solutions
- Enable metrics reporting of study development timelines and pre and post production changes to database
- Partner with Clinical Data Management Associate to deliver study database per business need and before first patient visit
- Comply with 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
Enterprise Leadership
- Continually seek and implement means of improving processes to reduce study build cycle time and decrease work effort
- 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 post production changes change control process
Minimum Qualification Requirements:
- 6 to 13 years database programming and system validation experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors
- Bachelor’s degree in computer science, engineering, medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy
- Job located in Bangalore, India
Other Information/Additional Preferences:
- Masters degree in medical field, Informatics, Life Sciences, Health Information Administration, Statistics, Information Technology, Nursing, Pharmacy, Business
- Experience with the following:
- Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions
- Deciding the technology platform (system/database) for data acquisition and aggregation
- Utilization of clinical/drug development knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK, Operations, Medical)
- Strong therapeutic/scientific knowledge in the field of research
- Society of Clinical Data Management certification
- Project management experience
- Vendor management experience
- Familiarity with clinical data tools and technologies
- Understanding and experience in using data standards
- Experience with designing and handling of eCOA data
- Knowledge of medical terminology
- Domestic and International travel may be required
Apply: https://lilly.wd5.myworkdayjobs.com/en-US/LLY/details/Principal-Study-Build-Programmer_R-78336?q=clinical%20trials&source=linkedin&jobFamilyGroup=99c6e09d03e801a7d2687e7ff04aec33&locations=11eaf73f269c01454efffa5b2c4c9d27&locationCountry=c4f78be1a8f14da0ab49ce1162348a5e
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