Clinical Data Management

Kalpita Desai

****.*******@*****.*** 252-***-**** McKinney, TX

https://www.linkedin.com/in/kalpitadesai/

SUMMARY Seasoned Clinical Data Manager with 20+ years of experience driving data quality, efficiency, and regulatory compliance in clinical trials. Proven ability to manage eCRF development, oversee data transfer agreements, and implement process improvements. Seeking to leverage expertise in data integrity and cross-functional collaboration to excel in a Clinical Data Manager role. WORK EXPERIENCE LabCorp North Carolina

Clinical Data Manager Jan 2023 - Present

• Oversee the design and implementation of eCRF screens, edit, and check procedures, incorporating multidisciplinary feedback to improve data precision.

• Develop and uphold Standard Operating Procedures and data standards to guarantee database integrity and compliance with management protocols.• Improve data management methodologies, resulting in a 20% enhancement in operational efficiency and meticulous upkeep of Trial Master Files and related study documentation.

• Guide team members in leveraging Electronic Data Capture systems, including REDCap, OpenClinica, and Oracle Clinica, to ensure precise data recording. Specialty Care Clinics Dallas

Clinic Manager Jan 2022 - Dec 2022

• Oversaw clinical operations to maintain compliance with HIPAA and labor laws, while addressing patient grievances proficiently.

• Liaised with insurance providers to secure patient needs, utilizing adept negotiation skills and proficiency in patient management systems and database applications.

• Enhanced patient care procedures, contributing to a significant 15% increase in patient satisfaction metrics.

Johnson & Johnson New Brunswick, NJ

Senior Clinical Data Specialist Jan 2019 - Dec 2021

• Oversaw data management procedures, data quality control measures to streamline data management procedures, achieving a significant 25% reduction in errors and enhancing data accuracy.

• Assist in the development and implementation of clinical Standard Operating Procedures and associated tools.

• Collaborated cross-functionally to develop data management plans and build robust clinical trial databases, ensuring perfect alignment with study protocols. Curious Caterpillar Montessori Dallas

Owner & Director Aug 2014 - Dec 2018

• Developed and implemented educational curriculum, improving the quality of instruction and aligning with accreditation standards.

• Oversaw operational management, including staff recruitment and professional development, ensuring adherence to regulatory compliance, executed effective marketing campaigns, resulting in a 30% increase in student enrollment. Bullseye DataTech

Clinical Data Coordinator Jan 2010 - May 2014

• Ensured data integrity and accuracy in clinical trials through meticulous quality control checks and resolution of data inconsistencies, adhering to regulatory standards.

• Supported data analysis and reporting initiatives by employing statistical software, aiding in the improvement of data-centric decision-making.

• Refined data entry methodologies, achieving a 15% boost in efficiency and precision of documentation procedures.

Sterling AddLife India Limited Hospital

Senior Executive Patient Care Manager Sep 2007 - Jun 2009

• Enhanced staff productivity and adherence to protocols by overseeing training initiatives that contributed to successful NABH accreditation.

• Elevated patient satisfaction by 20% by optimizing service delivery and effectively managing international patient care, ensuring successful treatment outcomes. Northwick Park Hospital London, UK

Healthcare Executive Intern Mar 2005 - Feb 2007

• Ensured adherence to confidentiality protocols and compliance with established trust policies, contributing to the maintenance of high standards of patient care.

• Managed oversight of critical care divisions and effectively utilized patient management software, fostering collaborative efforts to enhance community health initiatives.

AstraZeneca Pharmaceutical India Ltd

Regional Business Manager Sep 2002 - Feb 2006

• Directed regional resource distribution, focusing on critical care units, resulting in enhanced sales performance and market growth through strategic planning and comprehensive training initiatives.

• Coordinated scientific meetings and executed business advancement activities, while formulating territory management strategies to meet immediate and future objectives.

EDUCATION Kalinga University

Master of Science in Chemistry

Jun 2017

University of Paisley

Master of Science in Healthcare Management

Mar 2007

Vivekanand Education Foundation

Diploma in Medical Laboratory Technician

Jun 2002

North Gujarat University

Bachelor of Science in Chemistry

Jun 2000

CERTIFICATIONS ICH GCP Guideline, NIDA Clinical Trials Network August 2024 A Crash Course in Data Science (Coursera), Johns Hopkins University

Oct 2023

Data Management for Clinical Research (Coursera),

Vanderbilt University

May 2023

Diploma in Operations Management May 2022

Certificate in Facilities Management Apr 2022

Certificate in Becoming a Healthcare Administrator Mar 2022 SKILLS Regulatory Compliance • Database Management • Electronic Data Collection • Leadership • Critical Thinking • Data Analysis • HIPAA Compliance • Electronic Medical Records • Staff Recruitment • Problem-Solving • Clinical Trials Knowledge

• Data Management • Statistical Analysis • GCP/ICH guidelines • Database Design • Clinical Practices • 21 CFR • Database Design and Development • Database Design and Management • Risk Management • Strategic Reporting • Business Operations

• Healthcare Technology • Data Security • EMR software application • Patient Management System

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