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Candidate's Name
Mobile: PHONE NUMBER AVAILABLE Email : EMAIL AVAILABLELinkedIn: https://LINKEDIN LINK AVAILABLE PROFESSIONAL SUMMARY Proficient in coordinating and organizing clinical data management activities, creating regulatory-compliant databases, following regulations, and implementing efficient electronic data collection methods. I am experienced as a Clinical Data Manager and skilled healthcare administrator, capable of effectively leading teams, communicating with stakeholders, and managing projects with time constraints. Distinguished for exhibiting keen critical thinking abilities and a steadfast dedication to attaining remarkable results. Consistently demonstrate careful attention to detail and creative problem-solving when resolving issues. EDUCATIONMaster of Science in Chemistry June 2017Kalinga University, IndiaMaster of Science in Healthcare Management March 2007 University of Paisley, UKDiploma in Medical Laboratory Technician June 2002 Vivekanand Education Foundation, IndiaBachelor of Science in Chemistry June 2000North Gujarat University, IndiaPROFESSIONAL EXPERIENCEClinical Data Manager January 2023 PresentLabCorp, North Carolina Enhance the integrity and supervision of Clinical Trial studies by implementing robust data management practices . Review and manage critical data management documents, including Electronic Case Report Forms (eCRFs) completion guidelines and data management plans. Oversee development of eCRFs and data validation specifications, conducting user acceptance testing of eCRF screens and edit checks. Manage timelines with Contract Research Organizations (CROs) and coordinate cross-functional feedback for timely delivery of data extracts & review study statements of work for scope and cost considerations. Facilitate data transfer agreements and reconciliation between laboratory, safety vendors, and clinical databases. Prepare eCRFs and develop comprehensive edit checks, reconciliation guidelines, and test scenarios. Present at Investigator meetings and lead study closeout activities. Maintained Trial Master Files and studied documentation files, ensuring compliance and organization. Foster efficient coordination across cross-functional departments through effective teamwork and multitasking. Clinic Manager January 2022 December 2022Specialty Care Clinics, Dallas Ensure smooth daily operations, including scheduling and addressing patient satisfaction. Coordinate and manage clinical operations/strategic initiatives independently. Accountable for exceptional customer service, troubleshooting complaints, and implementing proactive process improvements while ensuring HIPAA compliance and labor law adherence. Utilize persistence and persuasion to advocate for patients with insurance companies. Assist in onboarding to establish and maintain a high-performing team. Proficient in Direct Marketing and Electronic Medical Records software for patient information management. Successfully managed clinic budget, billing, inventory, and equipment oversight. Develop and implement procedures for optimal patient care. Comprehensive knowledge of patient referrals, insurance, and critical medical documentation. Senior Clinical Data Specialist January 2019 - December 2021 Johnson & Johnson, New Brunswick, NJ Oversee data collection, cleaning, and validation, ensuring accuracy and reliability. Develop and implement data management plans and tools to streamline the process. Collaborate with cross-functional teams to design clinical trial databases tailored to study requirements. Utilize statistical methods to validate and analyze data, generating decision-making reports. Ensure adherence to data management guidelines and standards. Resolve data-related issues and provide training and mentoring to junior staff. Assess and improve data management processes, identifying areas for automation and standardization. Identify data quality risks and propose mitigation strategies to ensure integrity. Collaborate with external vendors or CROs for compliance and effective communication. Owner & Director August 2014 - December 2018Curious Caterpillar Montessori, Dallas Provide educational leadership and curriculum development. Manage school operations, staff recruitment, and development. Ensure compliance with regulations and accreditation standards. Plan and manage the school's budget. Handle marketing and communication.Clinical Data Coordinator January 2010 - May 2014Bullseye DataTech Enter and validate clinical data using electronic systems. Resolve data inconsistencies and conduct quality control checks. Aid in data analysis, reporting, and training, while ensuring accuracy and addressing discrepancies. Gather and review clinical trial data, including patient records and laboratory results. Perform quality control checks on collected data to ensure regulatory compliance. Assist in data analysis and generate reports using statistical software. Maintain accurate documentation and ensure adherence to regulatory requirements. Collaborate with research team members to coordinate data-related activities. Evaluate and enhance data management processes and contribute to developing standard operating procedures(SOPs).Senior Executive Patient Care Manager September 2007 - June 2009 Sterling AddLife India Limited Hospital Develop collaborative relationships with regional, national, and international patients. Manage international patient care and ensure treatment completion. Implement protocols to improve staff productivity and compliance. Coordinate staff training for NABH accreditation. Oversee patient rights, accessibility, and complaint resolution. Healthcare Executive Intern March 2006 February 2007 Northwick Park Hospital, London, UK Retain confidentiality and ensure compliance with trust policies and procedures. Oversee critical care divisions and utilize computerized patient management programs. Learn collaboration among healthcare organizations to improve community health. Regional Business Manager September 2002 - February 2006 AstraZeneca Pharmaceutical India Ltd Lead regional resource allocation to achieve objectives in critical care divisions. Increase sales, and growth through market understanding and training. Organize scientific meetings and implement activities for business success. Develop territory management plans for short and long-term goals. CERTIFICATIONS A Crash Course in Data Science (coursera), Johns Hopkins University, October 2023 Data Management for Clinical Research (coursera), Vanderbilt University, May 2023 Diploma in Operations Management, May 2022 Certificate in Facilities Management, April 2022 Certificate in Becoming a Healthcare Administrator, March 2022 REFERENCES: Available Upon Request |
