TRiNDS Team Spotlight: Shirley Chinta – Data Management Intern
All of us at TRiNDS come to work every day committed to conducting the best quality rare disease and neuromuscular research. In recognition of National Intern Day we are highlighting Shirley Chinta, TRiNDS Data Management Intern.
Can you tell us a bit about yourself and what drew you to TRiNDS/Data Management?:
My love for science began at a young age. Coupled with a growing passion for being a part of improving people’s lives, I was led to pursue the field of clinical research in which I obtained my undergraduate and master’s degrees. My career as a clinical data manager initially began in the fields of oncology and endocrinology. I was drawn to TRiNDS when I learned about their specialized focus on neuromuscular dystrophy and rare diseases. This opportunity with TRiNDS has continued to grow my deep-seated interest in expanding my expertise around rare disorders.
Broadly speaking, what is your favorite part about being a Data Manager at TRiNDS?:
I love being a part of the processes that bring new drugs into the market. Being a data management intern with TRiNDS, I have a chance to learn about new therapies for neuromuscular dystrophy and databases that coincide. It is fulfilling for me to be able to help people, both directly by helping my colleagues with different tasks or through my involvement in rare disease research.
Now let’s look more closely at your specific responsibilities…
What type of work have you completed on user acceptance testing for a database or edit checks?:
User Acceptance Testing (UAT) is performed to ensure the edit checks and the database are performing as intended.. At TRiNDS, I perform UAT, where data is entered into the test environment in the database to verify the database and edit checks are working as expected. UAT is done during the study build, before the database goes live.
Can you describe the process used for participant freeze?:
To start the process, the study data manager creates a participant freeze checklist which outlines the requirements for data freeze. The DM team then follows the steps below:
- Send email notification to site(s) officially informing them of the participant freeze
- Final review of CRF’s and external data.
- Confirm closure of all queries.
- Obtain review and approval of adverse events by the medical monitor
- Receive confirmation of review of clinical evaluator data
- Check for SDV completeness
- Confirm review and approval of medical coding
- Performing final SAE reconciliation
- Obtain site investigator signatures on all CRFs to be frozen.
- Finally, once all the above steps have been completed, SDM will freeze events/visits for a participant.
Can you share a bit about how TRiNDS encourages employee engagement through company activities and/or events?:
Every year I look forward to the TRiNDS annual retreat which takes place over the course of a few days in the fall. Being a remote company, this retreat is an opportunity for us to meet new team members in-person, socialize, and have interactive sessions where we learn more about the company goals. This helps employees build confidence with each other and recalibrate for the following year. For day-to-day engagement, TRiNDS utilizes a platform where employees are able to recognize and appreciate each other for their hard work.
