Vaishali Dongare

Bis 2019, Clinical Data Manager, eResearchTechnology GmbH, Germany
München, Deutschland

Fähigkeiten und Kenntnisse

Clinical Data Management
SQL
HTML
Microsoft Office
Training and mentoring
Mentoring
German language
CDM
Inform v4.6
Inform v6.0
Life Science
Drafting eCRF completion guideline
Test script review
Pre UAT testing
Screen review
writing specification for SAS checks
Expertise in Query Management/ Discrepancy Managem
SAE reconciliation
Vendor data reconciliation- Lab/PK/PGx/ECG/PFT/ Di
Cardiovascular
Therapeutic Area Expertise: Cardiovascular/ Respir
Communicate with Customers/ monitors/coders and ex
Archiving activity
Database freezing and locking
CV event reconciliation
Clinical data Manager
Clinical data Entry

Werdegang

Berufserfahrung von Vaishali Dongare

  • 1 Jahr, Nov. 2018 - Okt. 2019

    Clinical Data Manager

    eResearchTechnology GmbH, Germany

    • Preparation of DMP (Data management plan) and DTS (Data transfer specification). • Coordinate with sponsor/CRO and SAS programmer in order to finalize the specifications. • Generate and provide sample data as well as live study data per agreed timeline. • Serve as primary point of contact for query escalation and resolution. • Ensure high customer satisfaction by delivering on promises, meeting timelines and providing excellent customer service at all times.

  • 5 Jahre, Mai 2013 - Apr. 2018

    Clinical Data Manager

    Tata Consultancy Services Ltd

    Worked as a Senior Clinical Data Manager for different therapeutic areas like Cardiovascular, Respiratory, NeuroScience and Anemia. -Worked on Study startup, conduct & close out activities -Performed data cleaning, validation, query development & resolution for all on-going studies -Performed vendor data reconciliation (Lab, PK, PGx, ECG, PFT, Diaries) -SAE reconciliation -Providing study Trend analysis report to study team -Conducted all database release activities

Ausbildung von Vaishali Dongare

  • 2 Jahre und 3 Monate, Juni 2010 - Aug. 2012

    Bioinformatics

    University of Mumbai

    - Bioinformatics. -Biostatistics. - Academic project of Molecular interaction studies of some Napthoquinone derivatives against topoisomeraseI for anticancer drug therapy (May 2011-November 2011) using in silico drug design.

  • 3 Jahre und 2 Monate, Juli 2006 - Aug. 2009

    Biotechnology

    University of Mumbai

    - Genetics - Microbiology - Biochemistry - Cell Biology

Sprachen

  • Englisch

    C2 (Verhandlungssicher / Muttersprachlich)

  • Deutsch

    B1-B2 (Gute Kenntnisse)

  • Hindi

  • Marathi

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