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Data Management

Location:
Tracy, CA
Posted:
October 24, 2018

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Resume:

Vaishali Sangale

ac7hnt@r.postjobfree.com Phone: +1-408-***-****

SUMMARY

Over 5 years of healthcare related experience, including 3 years in clinical trial and data management, recently completed Certificate program in Clinical trials design and management

Experienced in Phase-I and Phase-II clinical trial activities and monitoring at site in Oncology and Respiratory medicine

Proficient in creating, maintaining and validating data management documents, clinical study database, handling trial responsibilities throughout the data-management lifecycle and Knowledge of CDISC, CDASH and SDTM

Trained pharmacist with an excellent understanding of drug development process, clinical trial methodology, FDA regulations, protocols and practices governing the participation of human subjects in research including the GCP

Analytical thinker with demonstrated talent for identifying, analyzing and solving problems

PROFESSIONAL EXPEREINCE

Clinical Data Manager

Cognizant Technology Solutions, Mumbai (May 2012 – July 2014)

Environment: Oracle Clinical EDC, J-Review and CREDI

Responsibilities

Managed all study start-up, data management activities, issues, and deliverables for studies as per trial specification document and SOP with focus on quality and timelines

Managed all aspects of electronic case report form (eCRF) design and development

Conducted documentation reviews and created critical CDM documents such as eCRF specifications, eCRF completion guidelines, annotated CRFs, data management plans and edit check specifications

Developed test cases and performed user acceptance testing of EDC systems to ensure quality and consistency of documentation and e-CRF

Engaged with Oracle Clinical developers on design, testing and Go-live of Study Database

Performed data Cleaning/Discrepancy Management of EDC system, lab data reconciliation and discrepancy management according to the SOPs to ensure compliance with the study protocol

Performed data review using standard reports and J-review, oversaw data discrepancy management, developed and executed ad hoc database queries utilizing data review and query tools

Oversaw data management activities in the absence and unavailability of Trial Data Manger/Lead Data Manager

Coordinated with Data Management study team and clients to track progress and ensured projects met timelines and quality expectations

Contributed to process improvement, highlighted future risks in studies and performed required root cause analysis

Clinical Data Management – Associate

Targeted Therapeutics Consulting Inc., Mumbai (May 2011 – Jan 2012)

Responsibilities

Collected and assembled research data to prepare database

Reviewed data entries for completeness and consistency

Assisted in putting research material into practice by computing the practical implications of the research findings

Maintained integrity while performing data management activities of procuring, analyzing, interpreting, processing and storage

Internship in Clinical Site Management

Tata Memorial Hospital, Mumbai (Dec 2010 – Feb 2011)

Responsibilities

Site monitoring activities:

Conducted Clinical Site Evaluation and feasibility study as per Sponsor’s working practices

Collected, reviewed and reconciled Essential documents

Verified e- Case Report Forms and Source documentations

Performed essential duties as needed for trial objectives

Managed clinical activity at site:

Performed study conduct tasks like obtaining Informed Consent Form from the patients, dispensing IP to patients, maintained log forms, lab reports and PK (Pharmacokinetic) sampling

Assisted in source data entry in e-CRF and resolved data queries in Remote Data Capture (RDC)

Involved in assessing and reporting Adverse events, Serious Adverse Events as per the ICH GCP Guidelines and Sponsor requirements

Served as a direct contact between study site and sponsor and coordinated all study related activities as required

EDUCATION AND CERTIFICATION

Clinical Trial Design and Management Certificate

University of California, Santa Cruz - Silicon Valley Extension (2018)

Master of Science (Clinical Research & Regulatory Affairs)

Sikkim Manipal University, Mumbai, India (2011)

Bachelor of Pharmacy

SNDT Women's University, Mumbai, India (2006)

Registered Pharmacist (India)



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