Skill required: Data Maintenance - Clinical Data Management (CDM)
Job Location: Hyderabad
Qualifications: Any Graduation
Years of Experience: 13-18 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 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.
The Clinical Data Management focuses on the collection, integration and the 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.
Roles and Responsibilities
- In this role you are required to identify and assess complex problems for area of responsibility
- The person would create solutions in situations in which analysis requires an in-depth evaluation of variable factors
- Requires adherence to strategic direction set by senior management when establishing near-term goals
- Interaction of the individual is with senior management at a client and/or within Accenture, involving matters that may require acceptance of an alternate approach
- Some latitude in decision-making in involved
- you will act independently to determine methods and procedures on new assignments
- Decisions individual at this role makes have a major day to day impact on area of responsibility
- The person manages large - medium sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture
- Please note that this role may require you to work in rotational shifts.
What are we looking for?
We are looking for individuals who have the following skillset:
- Ability to solve problems
- Build strong
- ongoing relationships with customers
It would be a value add if you are proficient in:
- Clinical Data Management (CDM)
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