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Purpose:
The Clinical Study Build Associate is responsible for programming and testing clinical trial data collection databases. This requires an in depth understanding of data technology, data flow, and data standards. The Clinical Study Build Associate will collaborate with the Clinical Data Management Associate, Clinical Data Associate and other key stakeholders to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Portfolio Delivery
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
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