Job Location: Bengaluru
Qualifications: Bachelor of Home Science/Bachelor of Pharmacy/BE
Years of Experience: 1-3 years
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What would you do?
You will be aligned with our Pharmaceuticals Processes vertical and help us with the processes to collect, monitor, research, assess and evaluate information on the adverse effects of medication with a view to identifying new information about hazards associated with medicines and consequently, prevent harm to patients. It also deals with the reviewing and resolving of discrepancies identified by the system or through manual checks as per guidelines. Employees under this span can also be responsible for a number of activities related to the design, development, and maintenance of Clinical Database objects.
You will be working as a part of the Data Maintenance team which is responsible for the completeness & validity of the data in the clinical database. The team reviews and resolves discrepancies identified by the system or through manual checks as per guidelines, issues data clarification forms as and when required. You will have to perform discrepancy review & perform Self-Evident Corrections per DRP (as and when required). You will also solve for discrepancy management for SAE related discrepancies.
The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. The role may require you to identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The role may also need expertise in managing clinical data management projects.
What are we looking for?
We are looking for individuals who have the following skillset:
Roles and Responsibilities
In this role, you are required to solve routine problems, largely through precedent and referral to general guidelines
Your expected interactions are within your team and direct supervisor
You will be provided detailed to a moderate level of instruction on daily work tasks and detailed instruction on new assignments and the decisions that you make that would impact your work
You will need to be well versed with basic statistics and terms involved in the day to day business and use it while discussing with stakeholders
You will be required to help in the overall team’s workload by managing your deliverables and help the team when required
You will be an individual contributor as a part of a team, with a predetermined focused scope of work.
Please note this role may require you to work in rotational shifts.
Bachelor of Home Science/Bachelor of Pharmacy/BE