Eli Lilly Life Science Clinical Study Recruitment – Applications Invited
Eli Lilly Life Science Clinical Study Recruitment – Applications Invited. Life Science / Informatics Clinical Study Build Job Opening. Interested and eligible applicants can check out all of the details on the same below:
The Clinical Study Build Associate is accountable for programming and also testing clinical trial data collection databases. This requires an extensive 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 as well as various other key stakeholders to deliver standard data collection methods and innovative validation solutions for usage in global clinical trials.
Primary Obligations: This job description is intended to provide a basic overview of the job requirements at the time it was prepared. The job requirements of any kind of position may change over time and may include extra responsibilities not specifically described in the job description. Consult with your supervision concerning your actual job responsibilities and also any type of related duties that may be required for the position.
- Program as well as test data collection systems for a trial or set of trials within a program making use of data standards library
- Guarantee data collection systems are delivered accurately, efficiently and also 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 as well as regulatory response activities.
- Boost speed, accuracy, and uniformity in the development of systems solutions.
- Enable metrics reporting of study development timelines and pre and also post-production changes to the database.
- Partner with Clinical Data Management Associate to deliver study database per business need and prior to the first patient see.
- Follow data standard decisions and also strategies for a study and/or program.
- Utilize therapeutic knowledge and possess a deep understanding of the technology utilized 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.
- Continually look for and implement means of improving procedures to reduce study build cycle time as well as decrease work effort.
- Represent Data as well as Analytics processes in cross-functional initiatives.
Actively take part in shared learning across Data as well as Analytics organization.
- Work to Increase the re-usability of forms and edits by improving the initial design.
- Work to reduce post-production changes change control process.
Minimum Qualification Requirements:
- 3 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, Stats, Information Technology, Nursing, Pharmacy.
Job located in Bangalore, India.
Other Information/Additional Preferences:
- Masters degree in the medical field, Informatics, Life Sciences, Health Information Administration, Stats, Information Technology, Nursing, Pharmacy, Business.
Experience with the following:
- Articulating the flow of data (structure as well as format) from patient to analysis as well as apply this knowledge to data solutions.
- Deciding the technology platform (system/database) for data acquisition as well as aggregation.
- Usage of clinical/drug development knowledge and also an ability to liaise effectively with study team members (i.e. Data Sciences, Stats, PK, Operations, Medical).
- Solid 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 as well as technologies.
- Understanding and also experience in using data standards.
- Experience with designing and also handling of eCOA data.
- Knowledge of medical terminology.
- Domestic and also International travel may be required.
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