Skill required: Clinical Data Management (CDM) - Study Build
Designation: Management Level - Team Lead/Consultant
Job Location: Bengaluru
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.
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. They help 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 team also managing clinical data management projects.
In this role, you will work with the Study Build Team and help provide subject matter expertise in developing clinical study database by building electronic case report forms (eCRF) and program Edit Checks as per specifications in the EDC platform and perform unit testing, technical review, and fix UAT issues if any. They also support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. The team participates in technical review of databases developed by other Study Builders, supports any updates or changes to the study (e.g. protocol amendments), conducts change control process, resolves and updates issues arising from UAT including study database, eCRF, and edit checks. The team is also responsible for conducting root cause analysis and coming up with preventive action.
What are we looking for?
We are looking for individuals who have the following skillset:
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.