Skill required: Clinical Data Management (CDM) - Study Build
Job Location: Bengaluru
Qualifications: Bachelors of Information Technology/BE/BTech/MCA
Years of Experience: 3-5 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.
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:
- Adaptable and flexible
- Ability to perform under pressure
- Ability to establish strong client relationship
- Ability to work well in a team
- Ability to meet deadlines
Roles and Responsibilities
- In this role, you are required to analyze and solve lower-complexity problems
- Your day to day interaction is with peers within Accenture before updating supervisors
- You may have limited exposure with clients and/or Accenture management
- You will be given moderate level instructions on daily work tasks and detailed instructions on new assignments
- You will need to be well versed with basic statistics and terms involved in the day to day business and use it while discussing with stakeholders
- You will be expected to constantly be on the lookout for ways to enhance value for your respective stakeholders/clients
- The decisions you make impact your work and may impact the work of others
- You will be an individual contributor as a part of a team, with a focused scope of work.
Please note this role may require you to work in rotational shifts.
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Our more than 600,000 people in more than 120 countries, combine unmatched experience and specialized skills across more than 40 industries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.