Skill required: Data Maintenance - Clinical Data Management (CDM)
Designation: Management Level - Team Lead/Consultant
Job Location: Hyderabad
Years of Experience: 7-11 years
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:
- Clinical Data Management (CDM)
- Data Management
- Ability to perform under pressure
- Ability to establish strong client relationship
- Agility for quick learning
- Ability to work well in a team
Roles and Responsibilities
- In this role, you need to analyze and solve moderately complex problems
- You are required to create new solutions, leveraging and, where needed, adapting existing methods and procedures
- You are required to understand the strategic direction set by senior management, clearly communicate team goals, deliverables, and keep the team updated on change
- Your primary upward interactions are with your direct supervisor
- You may interact with peers and/or management levels at a client and/or within Accenture
- You will be provided with guidance when determining methods and procedures on new assignments
- The decisions that are made by you will often impact your team
- You would be an individual contributor and/or oversee a small work effort and/or team.