SHWETA GAIKWAD
Centennial,CO
Summary
In my tenure as a Quality Analyst at Omega Healthcare, I audited clinical data with a focus on oncology, ensuring accuracy and completeness across multiple projects. With over five years of experience, I specialize in process improvement, people management, attention to detail, and implementing best practices to enhance team performance and quality standards. I hold a Bachelor of Pharmacy degree from Mumbai Educational Trust, with a strong foundation in medicinal chemistry, pharmacology, and clinical research. Passionate about improving healthcare quality, I continuously strive for professional growth and development in this field. My commitment to excellence drives my dedication to ongoing learning and innovation.
Overview
5
5
years of professional experience
Work History
QUALITY CONTROL ANALYST
VASTA GLOBAL LLC (Omega Healthcare )
02.2022 - 01.2025
- Conduct regular audits of clinical data across various databases, utilizing thorough knowledge of SOPs and protocols to ensure accuracy, compliance, and adherence to project guidelines.
- Identify and address discrepancies in production and client trackers; work closely with operations to ensure data integrity.
- Provide real-time feedback to curators to correct erroneous data and perform Root Cause Analysis (RCA) when needed.
- Serve as the main point of contact for client inquiries related to clinical data and project protocols.
Resolve client queries in a timely manner, ensuring satisfaction and clarity around data-related concerns. - Collaborating and following up with investigators for CRR completion notification in the PIMS, Investigator's Brochure, Amendment and protocol deviation submission.
- Monitoring calendar of NCI protocol site visit and submission of findings and protocol deviations to the study team on timely basis
- Anticipate potential data quality issues and initiate the Corrective and Preventive Action (CAPA) process to address them.
- Work with internal teams to implement targeted solutions for identified quality challenges.
- Train new associates on domain-specific knowledge, quality assurance processes, and QA database systems.
- Provide ongoing guidance and feedback to ensure team members are proficient in data management and quality standards.
- Collaborate with cross-functional teams to develop strategies for quality assurance and process improvements.
- Prepare and distribute regular reports on quality metrics, project observations, and discrepancies to senior management.
- Revise procedures, checklists, and job aids to minimize errors and improve quality control processes.
- Monitor trends in quality metrics and project performance, providing timely updates and recommendations to leadership.
QUALITY EXPERT
INVENTURUS KNOWLEDGE SOLUTIONS PVT. LTD
10.2021 - 02.2022
- Responsible for accurately processing and identifying documents for data abstraction and filing, ensuring that all records were correctly categorized and stored.
- Consistently met deadlines and targets by effectively managing time and prioritizing tasks, contributing to the overall efficiency of the team.
- Participation in the Process Excellence Program to monitor performance of individuals or teams that may be underperforming.
- Implemented strategies to reduce errors and minimize client rejections, resulting in improved quality and client satisfaction.
- Conducted thorough document audits and provided detailed reports to the team leader, ensuring all quality standards were met and exceeded.
- Demonstrated strong decision-making skills and problem-solving abilities, addressing challenges proactively and ensuring smooth workflow in the UDAAN Project.
- Actively contributed to a positive and productive team environment, collaborating effectively with team members to achieve collective goals and enhance overall team performance.
ASSOCIATE
INVENTURUS KNOWLEDGE SOLUTIONS PVT. LTD
10.2019 - 10.2021
- Effectively processed clinical documents of the EMR, ensuring accurate identification and data abstraction for efficient filing in the doctrac site
- Demonstrated excellent time management skills, consistently meeting and exceeding project deadlines and targets.
- Conducted regular audits of clinical documents, providing detailed reports to team leaders for process improvement.
- Provided timely solutions to operational challenges, facilitating smooth workflow and high-quality output.
- Contributed to team success by fostering a collaborative environment, promoting continuous learning, and offering guidance to associates.
- Promoted to SME after demonstrating strong analytical skills and leadership potential. Led a team of 15 associates, overseeing daily operations, mentoring staff, and ensuring adherence to quality standards.
- Supported team development through training, performance reviews, and constructive feedback, driving individual and team success.
Education
Degree - Bachelor of Pharmacy
MET INSTITUTE OF PHARMACY
India05-2019
INTERNSHIP
WATSON PHARMACEUTICALS PVT
India2018
Skills
- Good analytical thinking and Passionate towards work
- Quick learner and ability to grasp faster
- Capability to deal with stress
- Keen eye for detail at work
- Good team player
- Customer focus
Accomplishments
- Quarterly Star Award (April 2023- June 2023)
- Spot light awards for the month of march 2023 and September 2022.
- Credo spark award for the month of May and June 2024.
- Initiated Process Improvement by implementing rulebook to ensure smooth workflow for all the stakeholders. Created rulebook for the Exercise Oncology project to which Client incorporated the directives in the Redcap database to refer the rulebook for the detailed training.
- Streamlined the Exercise and Infectious disease project to 99% efficiancy by reducing errors by 45%
ACHIEVEMENTS
- Quarterly Star Award (April 2023- June
2023) - Spot light awards for the month of march
2023 and September 2022. - Initiated Process Improvement by implementing rulebook to ensure smooth workflow for all the stakeholders.
- Created and Implemented rulebook for the
Exercise Oncology project to which Client
incorporated the directives in the Redcap
database to refer the rulebook for the
detailed training. Rulebook has been
placed in the common path by the client.
PROJECTS
- Exercise Oncology (DatabaseRedcap)-
- Infectious Disease (DatabaseRedcap)
- Pediatrics Non Neuroblastoma (Database-
CRDB and Formnet). - NCI Monitoring & NCI LTFU (PIMS,
Imedidata, Regulatory audits, RD etc).
Timeline
QUALITY CONTROL ANALYST
VASTA GLOBAL LLC (Omega Healthcare )
02.2022 - 01.2025
QUALITY EXPERT
INVENTURUS KNOWLEDGE SOLUTIONS PVT. LTD
10.2021 - 02.2022
ASSOCIATE
INVENTURUS KNOWLEDGE SOLUTIONS PVT. LTD
10.2019 - 10.2021
Degree - Bachelor of Pharmacy
MET INSTITUTE OF PHARMACY
INTERNSHIP
WATSON PHARMACEUTICALS PVT
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