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 CDM - Clinical Data Management team which is responsible for the completeness and validity of the data in the clinical database. They review and resolve discrepancies identified by the system or through manual checks as per guidelines. Issue data clarification forms as and when required. Perform discrepancy review and perform Self-Evident Corrections per DRP (as and when required). Perform discrepancy management for SAE related discrepancies.
You will be responsible for Clinical Data Management where in you will ensure completion and validity of the clinical trial data that has gone through data entry with good quality. You will need to provide support to PDMs to develop and update guidelines. You will also need to develop editing tips and tools like J-review reports to improve editing quality. You will have to review and resolve discrepancies identified by the system through manual checks as per guidelines.
Good to have skills: Good communication skills
Roles and Responsibilities
In this role you are required to solve routine problems, largely through pre cedent and referral to general guidelines. Expected interaction is within own team and direct supervisor. Detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments would be provided. Decisions impact own work. Individual contributor as a part of a team, with a predetermined, focused scope of work.