Experience

ERT

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Data Manager

  • Sep 2021 - Present

  Philadelphia, Pennsylvania, United States

• Project Management

  • Mar 2019 - Sep 2021

  Greater Philadelphia Area - Delivered superior customer service by providing best business practices and support in using ERT’s products for the duration of client’s clinical trials - Worked and collaborated with project team/s of diverse talents (Project Manager, Data Management, Archive team, etc) in development and delivery of ERT products to help clinical research industry obtain high quality data. - Pro-actively managed lifecycle of issues from being reported by customer to its resolution by the support and… Show more - Delivered superior customer service by providing best business practices and support in using ERT’s products for the duration of client’s clinical trials - Worked and collaborated with project team/s of diverse talents (Project Manager, Data Management, Archive team, etc) in development and delivery of ERT products to help clinical research industry obtain high quality data. - Pro-actively managed lifecycle of issues from being reported by customer to its resolution by the support and development teams. - Responsible for recording and tracking key project monitoring and tracking metrics. - Responsible for meeting regularly with clients via phone and/or web to provide weekly monitoring updates, track on-going issues and communicate project status. - Responsible for meeting regularly with Team Leader to discuss workload, communicate project issues and address individual development. - Fulfilled following study specific tasks during each phase of the project. Development – (Study Documentation, Deployment Planning, Internal Training) Monitoring – (Project Reporting, Issue management and resolution, Project process improvements, Mid Study Changes, Inventory management) Close Out – (Data reconciliation and resolution, Inventory reconciliation, Study documentation management)`



University of Pennsylvania School of Medicine

• Higher Education
• 700 & Above Employee

• Clinical Data Manager

  • Sep 2016 - Jan 2019

  Greater Philadelphia Area • Responsible for data quality and documentation for assigned clinical trials conducted within the Center for Cellular Immunotherapies to ensure that the clinical data collection is accurate and all protocol requirements are captured • Responsible for providing clinical data management support for assigned Center for Cellular Immunotherapies (CCI)-Initiated protocols, including all tasks associated with study data management necessary for DSMB meetings/reports, IND Annual Reports, monthly… Show more • Responsible for data quality and documentation for assigned clinical trials conducted within the Center for Cellular Immunotherapies to ensure that the clinical data collection is accurate and all protocol requirements are captured • Responsible for providing clinical data management support for assigned Center for Cellular Immunotherapies (CCI)-Initiated protocols, including all tasks associated with study data management necessary for DSMB meetings/reports, IND Annual Reports, monthly reports, and interim data reporting/database locks, as well as ad hoc queries. • Independently create CRFs (Case Report Forms) in an electronic database system to collect required data from all clinical trials. • Assist in the development and review of study-specific data management documents, including Data Management Plans and Case Report Form Completion Guidelines, as well as sponsor data management standard operating procedures. • Facilitate data cleaning activities including data review and query generation for assigned protocols • Interact with the Sponsor/Sponsor Program Managers, Project Managers, Monitors, Statisticians, Clinical Investigators, Clinical Cell and Vaccine Production Facility (CVPF), and Translational and Correlative Studies Lab (TCSL) to ensure required data is captured. Show less



Hahnemann University Hospital

• United States
• Hospitals and Health Care
• 500 - 600 Employee

• Healthcare Consultant - Internship, Part of MHA Program

  • Mar 2015 - Jun 2015

  Greater Philadelphia Area • Participated in the project studying ‘Gap Analysis and Validation of Operational Standards’ as part of practice issues and management coursework • Performed a review of the clinic’s operational work-plan and a gap analysis to compare the standards proposed in the work-plan to the actual practice • Generated detailed reports and issued recommendations focusing on patient outcomes to facilitate decision-making and influence process improvement, and long term operations planning



Shiv Sahay Children Hospital

• General Practitioner

  • Aug 2010 - Nov 2012

  Uttar Pradesh, India • Worked under highly experienced and qualified physicians and observed the important procedures like ECG, Urinary Catheterization, Lumber Puncture, Nebulization, Paracentesis, Endoscopy and Nasogastric intubation • Performed history taking, physical examinations, charting, Immunizations, and prescription writing. • Managed all front office activities to optimize facility workflows and patient management • Provided comprehensive administrative support to the clinic by managing… Show more • Worked under highly experienced and qualified physicians and observed the important procedures like ECG, Urinary Catheterization, Lumber Puncture, Nebulization, Paracentesis, Endoscopy and Nasogastric intubation • Performed history taking, physical examinations, charting, Immunizations, and prescription writing. • Managed all front office activities to optimize facility workflows and patient management • Provided comprehensive administrative support to the clinic by managing scheduling, answering the phone, compiling medical records and charts, transferring lab results to the appropriate clinician, maintaining supplies and the appearance for the clinic • Ordered and distributed office supplies while adhering to a fixed-office budget Show less



Era Lucknow Medical College

• Intern

  • Jul 2009 - Jul 2010

  Lucknow Area, India Completed rotation in the following areas for a period of 12 months: Anatomy, Physiology, Biochemistry including Biophysics, Pathology, Microbiology, Pharmacology, Forensic Medicine including Toxicology, Medicine, Pediatrics, Surgery including Orthopedic Surgery, Obstetrics & Gynecology, Ophthalmology, Oto-Ryno-Laryngology and Community Medicine.