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Shreeram Das

Angestellt, Clinical Data Analytics Manager, Nimble Clinical Research
Rajbiraj, Nepal

Fähigkeiten und Kenntnisse

Clinical Data Management
eCRF
Data Management Plan
eCRF Completion Guidelines
Edit Checks Specifications
Clinical Protocol
Data Cleaning
Vendors Data Reconciliation
Project Management
eTMF
CTMS
RAVE
IBM C
InForm 6.2
Data Analysis
Regulatory Compliance
Aduit
Pharmacology
EDGE Soft Skills Level I and Level I
SAS Programming
German language
Administration
Analytics
Database
Clinical Research
MS Office
Project Planning
Process Optimization
Clinical Trials
English Language
Artificial intelligence
Retrieval-Augmented Generation (RAG)
Clinical Data Analysis
Statistics

Werdegang

Berufserfahrung von Shreeram Das

  • Bis heute 11 Monate, seit Juli 2024

    Clinical Data Analytics Manager

    Nimble Clinical Research

    • Project Manager for multiple cross-functional projects, overseeing all phases of project management including planning, execution, and stakeholder coordination. • Led the design, development, and testing of clinical dashboards for CDM, Medical Monitors, and Clinical teams, enhancing data accessibility and decision-making. • Provided technical leadership and training in CDM processes, ensuring teams were aligned with best practices and operational efficiencies. Use of AI in Use Case Automation

  • 1 Jahr und 6 Monate, Jan. 2023 - Juni 2024

    Clinical Data Team Lead

    PPD, part of Thermo Fisher Scientific

    Responsible for leading activities of Clinical Data Management from start-up to close out. Cross functionally working with different team members to get the project deliverables. Reporting to Sponsor, study team and internal management with all kinds of study related updates. Mentoring juniors and collogue for Clinical Data Management activities. Preparing timelines, budgets and looking for project utilization.

  • 6 Monate, Juli 2022 - Dez. 2022

    Principal Clinical Data Manager

    CBCC Global Research

    Responsible for handling a DM team as a project manager and getting activities accomplished in given timelines meeting sponsor, CBCC standards in accordance to given SOPs and given timelines. Cross functionally working with sponsors, internal CBCC team, vendors and other applicable team for DataManagement related activities. Timely provides an updates to sponsor and internal project team during meetings. Responsible for training and mentoring for applicable team members with respect to Data Management

  • 1 Jahr und 7 Monate, Dez. 2020 - Juni 2022

    Sr. Clinical Data Coordinator

    IQVIA RDS. Pvt. Ltd.

    Performed study operational activities i.e. query management, data review, data reconciliations. Created study specific metrics i.e. Quality and TAT, maintained Operational Issue Log. Responsible for the oversight of data cleaning for allocated studies which includes query count and study status. Drafted Clinical Data Management operation documents: Data Management Plan, eCRF completeness guidelines (CCG), Data Review Guidelines, Validation/ testing plan and Data Transfer Agreements specifications.

  • 2 Jahre und 4 Monate, Sep. 2018 - Dez. 2020

    Clinical Data Analyst

    Covance India Pharmaceutical Service Solutions

    Performed eCRF Screen review based on the protocol requirements or specification provided that is interpretation of protocol against eCRF designed. Drafted Data Management documents: DMP, CCG, Data Review Guidelines and Data Transfer Agreement/ Specifications. Performed Clinical Data Review, Query Management, SAE Reconciliation, and Vendor Data Reconciliation. Responsible to create study specific metrics i.e. Quality and TAT. Performed all activity associated to Database lock, Decommission and Archiving.

  • 2 Jahre und 1 Monat, Aug. 2016 - Aug. 2018

    Project Assistant Level I and II

    Pharmaceutical Product Development

  • 1 Jahr und 3 Monate, Apr. 2015 - Juni 2016

    Clinical Process Associate

    Quintiles Research Pvt. Ltd.

Ausbildung von Shreeram Das

  • 2 Jahre und 1 Monat, Juni 2015 - Juni 2017

    Master in Pharmacology

    Rajiv Gandhi University of Health Sciences

Sprachen

  • Englisch

    Fließend

  • Deutsch

    Grundlagen

  • Nepali

    -

  • Maithali

    -

  • Hindi

    -

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