Skill required: Data Maintenance - Clinical Data Management (CDM)
Designation: Management Level - Senior Analyst
Job Location: Hyderabad
Years of Experience: 5-8 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:
- Adaptable and flexible
- Ability to perform under pressure
- Problem-solving skills
- Detail orientation
- Ability to establish strong client relationship
It would be a value add if you are proficient in:
Roles and Responsibilities
- In this role, you need to analyze and solve increasingly complex problems
- Your day to day interactions is with peers within Accenture
- You are likely to have some interaction with clients and/or Accenture management
- You will be given minimal instruction on daily work/tasks and a moderate level of instructions on new assignments
- You will need to consistently seek and provide meaningful and actionable feedback in all interactions
- You will be expected to be constantly on the lookout for ways to enhance value for your respective stakeholders/clients
- Decisions that are made by you will impact your work and may impact the work of others
- You would be an individual contributor and/or oversee a small work effort and/or team.