Soumya Satpathy
Bangalore
Summary
Highly skilled Clinical Data Specialist with substantial experience in maintaining and auditing patient clinical data. Strong background in compliance with regulatory standards, managing databases, and ensuring accuracy of medical records. Recognized for innovative problem-solving skills and improving data management procedures to enhance efficiency. Proven ability to build strong relationships with multidisciplinary teams to ensure quality of data collection and reporting.
Overview
5
5
years of professional experience
Work History
Clinical Data Specialist
IQVIA(Quintiles IMS)
Bangalore
07.2019 - Current
- Provided guidance and mentorship to junior team members. Served in the role of backup to a Data Operations Coordinator or Data Team Lead.
- Reviewed case report forms for accuracy and completeness according to protocol specifications.
- Analyzed complex datasets to identify trends or patterns in the data.
- Prepared periodic reports summarizing study progress and outcomes.
- Coordinated with internal stakeholders during audits conducted by sponsors or regulatory agencies. Be audit ready and participate in audit meetings as required.
- Performed data validation tasks to ensure accuracy and completeness of clinical trial data. Perform comprehensive quality control procedures.
- Performed comprehensive quality control procedures.
- Identified discrepancies between collected data and original source documents; resolved issues by working with investigators or other staff members.
- Tailored data management plans to specific projects to effectively reach deadlines.
- Data reviewing and cleaning in compliance with study protocol and eCRF completion guideline. Reviewed study documents (like Protocol, DMP, etc.) And suggested edit checks to be added or updated in the study.
- Vendor data reconciliation.
- Query/Discrepancy Management
- Manual and SAS listing review.
- Study closeout.
Education
Bachelor of Pharmacy - Medicine
Indira Gandhi Institute of Pharmaceutical Sciences
Bhubaneswar, Odisha04-2018
Skills
- Conflict resolution techniques
- Regulatory compliance understanding
- Project management abilities
- Decision-making capabilities
- Teamwork and Collaboration
- Audit management
- Task Prioritization
- Discrepancy management
- Team Collaboration
- Quality Control
- Time Management
- Data organization
- Multitasking
- Analytical Thinking
- Team building
Personal Details
- Father’s Name: Hemant Kumar Satpathy
- Mother’s Name: Alaka Satpathy
- Birth Date: 2nd Jan 1997
- Gender: Female
- Marital status: Single
- Nationality: Indian
- Languages Known: English, Odia, Hindi and Bengali
Timeline
Clinical Data Specialist
IQVIA(Quintiles IMS)
07.2019 - Current
Bachelor of Pharmacy - Medicine
Indira Gandhi Institute of Pharmaceutical Sciences
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