Lilly B Pharmacy Job Opening 2023 – Candidates Apply Online
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Lilly hiring pharmacy job opening 2023. Bacleros in pharmacy may apply for the job vacancy at Lilly. Assoc Mgr/Sr. Assoc Mgr (SBP) job opening 2023. Pharmacy job opening 2023. Pharmacy job opening 2022. Check out all the details
Job Title: Assoc Mgr/Sr. Assoc Mgr (SBP)
Location Bangalore, Karnataka, India Category Research & Development
Job Type Full time Regular
Job Id R-41625
- 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
The Clinical Study Build Associate is responsible for programming andtesting 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.
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.
- 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
- 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
- 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
Possible questions and answers on the above job role:
- What experience do you have in articulating the flow of data from patient to analysis and applying that knowledge to data solutions?
Answer: I have experience in designing and implementing data solutions for clinical trials. I have worked on various projects where I have articulated the flow of data from patients to analysis and implemented solutions that ensured efficient and accurate data collection.
2. How do you decide on the technology platform (system/database) for data acquisition and aggregation?
Answer: I have expertise in various technologies and platforms that are commonly used for data acquisition and aggregation in clinical trials. Based on the study requirements, I evaluate the pros and cons of each platform and select the most appropriate one that meets the study’s needs.
3. How do you utilize clinical/drug development knowledge to liaise effectively with study team members?
Answer: I have worked closely with study team members such as Data Sciences, Statistics, PK, Operations, Medical, and have utilized my knowledge of clinical and drug development to understand their requirements and effectively communicate with them. This has helped in ensuring that the study data is collected and managed efficiently.
4. What experience do you have in project management and vendor management?
Answer: I have experience in managing projects related to clinical trial data collection and management, where I have worked closely with vendors and other stakeholders. I have managed timelines, resources, and budgets to ensure that the project is delivered on time and within budget.
How do you ensure compliance with data standard decisions and strategies for a study and/or program?
Answer: I ensure compliance with data standard decisions and strategies by understanding the relevant internal, external, and regulatory requirements/expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc.). I also work closely with the study team to develop and implement standard operating procedures (SOPs) and ensure that they are followed throughout the study lifecycle.
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