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Post : Senior Analyst - Data Maintenance
Job Description
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.
Roles and Responsibilities
• In this role, you need to analyze and solve moderately complex problems
• You will typically be creating new solutions, leveraging and, where needed, adapting existing methods and procedures
• The role requires a clear understanding of the strategic direction set by senior management as it relates to team goals
• You will need to hold monthly meaningful conversations with team members to discuss performance, coaching and feedback, training needs, and career discussions
• You will need to monitor & drive team performance, including throughput and quality as per defined metrics
• Your primary upward interaction is with a direct supervisor or team leads
• You will generally interact with peers and/or management levels with clients or internal stakeholders
• You will be provided with minimal guidance when determining methods and procedures on new assignments
• Decisions that you make often impact the team in which they reside and occasionally impact other teams
• You would be managing medium-small sized teams and/or work efforts at a client or within Accenture.
Candidate Profile :
• Qualifications
Bachelor of Pharmacy/BSc/Master of Pharmacy
• skillset:
- Clinical Data Review
- Data Management
- Adaptable and flexible
- Problem-solving skills
- Detail orientation
- Ability to establish strong client relationship
- Agility for quick learning
Additional Information
Qualification : Any Graduation
Location : Noida
Experience : 5-8 years
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Pharmacovigilance & Drug Safety Surveillance
End Date : 15th November, 2022
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