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 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, issue 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.
In Clinical Data Management (CDM) help in collection, integration & availability of data at appropriate quality & cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). 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.
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.
Required Candidate profile
1. Graduate or Post-Graduate in a quantitative field .engineering or economics or statistics. or Management
2. Strong academic background
3. Risk certifications such as FRM or actuarial certifications preferred
4. Business fluency in one or more mainstream European languages strongly preferred
5. Exposure to working in globally distributed workforce environment including offshore model preferred
6. Willingness to travel up to 50% of the time
7. Excellent communication and interpersonal skills