Debarshi Das

Debarshi Das Email and Phone Number

RTSM Project Manager and (ex-)Randomization Officer @ Keyrus Life Science
Brussels, BE
Debarshi Das's Location
Brussels Metropolitan Area, Belgium
Debarshi Das's Contact Details

Debarshi Das work email

Debarshi Das personal email

About Debarshi Das

My Offering:I have 20+ years of comprehensive professional experience in Business-IT world together with an MBA with specialization in Business strategy. With this well-proven experience and skill set, I am offering to bring added values to your organisation by,- Analyzing the key challenges, simplifying and optimizing the existing solutions, processes and new ideas- Choosing the right solutions comparing costs, risks, benefits, organisational priorities and management interests- Shaping up the vision of organizational mission critical system needs- Implementing the solutions and creating a sustainable business process and support structureI aspire to bolster my strategic role in Pharma / Med Device Industry. Competencies:End-to-end Project Management responsibility from concept phase to system implementation, Business Analysis, Requirement Analysis, Project Planning, Project Execution, running Request For Proposal/Quotation (RFP/RFQ) to select vendors, internal efficiency gain project to multi-million dollar cost saving project, Customer Relationship Management, Vendor Management, Change Management, SQA activities wearing multiple hats as needed. Experience in Clinical Systems for Clinical Operations(CTMS, ETMF, Contract Management), Data Management(EDC), Interactive Web Response / Randomisation System (IWRS) / IRT / RTSM , Clinical Quality(workflow, CAPA system, Business Process Modelling) as well as Computer System Validation(CSV), ICH - GCP, ISO14155, QMS, 21 CFR Part11, SQA.

Debarshi Das's Current Company Details
Keyrus Life Science

Keyrus Life Science

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RTSM Project Manager and (ex-)Randomization Officer
Brussels, BE
Website:
keyruslifescience.com
Employees:
221
Debarshi Das Work Experience Details
  • Keyrus Life Science
    Rtsm Project Manager And (Ex-)Randomization Officer
    Keyrus Life Science
    Brussels, Be
    View
  • Keyrus Life Science
    Rtsm Project Manager / (Ex-)Randomization Officer
    Keyrus Life Science Jul 2017 - Present
    Wavre, Belgium
    Part of GSK's RTSM / IRT PM team (previously part of Randomization Office team) , on behalf of CRO, Keyrus Life Science, have been instrumental in delivering large number of pivotal and non confirmatory trial setup, maintenance, process definition, training and business support of clinical studies in the Randomization and Trial Supply Management system (RTSM / IRT), supported reg audit and inspections, expert on different Randomization methodologies ( permuted block, minimisation, re-randomization ), different supply techniques( automatic, manual ), (un-)blinding, subject cappings etc, responsible for some of the most challenging and prioritised study designs. Previously part of GSK Vaccine's Clinical Systems team, acting as interface between Business end users and IT, driving multiple projects and initiatives, supporting clinical trial teams on daily basis, focusing on CTMS, IRT/RTSM systems.
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  • Johnson & Johnson
    Senior Software Quality Assurance Analyst
    Johnson & Johnson Dec 2016 - Jul 2017
    Belgium
    Helping JnJ IT project teams to deliver high quality software and reducing cost of rework; as Sr. SQA consultant.The GxP and non-GxP projects are conducted in Agile Scrum methodology, using tools like JIRA, HP ALM, Documentum etc.
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  • Cll Centres De Langues
    Student Of French Language Course
    Cll Centres De Langues Jan 2016 - Feb 2016
    Brussels Area, Belgium
    Intensive French Course B1.1 and B1.2.
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  • Abbott Vascular
    Project Manager - Senior Business Analyst
    Abbott Vascular Aug 2011 - Dec 2015
    Brussels Area, Belgium
    Responsible for analyzing business challenges and bringing in new systems or process automation with careful evaluation of ROI, business needs and long term benefits. Implemented system solutions as Project Manager on Global scale for Clinical Development / Clinical Research in close collaboration with IT, vendors and different business groups.Involved in Process Improvements, System Validation (CSV), Vendor Contract negotiations, Vendor Management, System Support around Clinical Operations, Clinical Data Management, Clinical Quality etc.
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  • Emlyon Business School
    Student Of International Mba
    Emlyon Business School Sep 2009 - Aug 2010
    Lyon Area, France
    During the one year Full Time MBA, specialised in International Business Strategy. Successfully completed a year-long project for French electrical engineering company SNEF to find the best strategy to penetrate UK market along wth three other participants of MBA programme.
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  • Thomson Reuters Eximius
    It Consultant
    Thomson Reuters Eximius Apr 2007 - Aug 2009
    Antwerp Area, Belgium
    IT consultant on Portfolio Management product in Thomson Reuters eXimus (external), specilaised in reporting and compliance.
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  • Tata Consultancy Services Asia Pacific Pte. Ltd.
    It Consultant
    Tata Consultancy Services Asia Pacific Pte. Ltd. Sep 2000 - Mar 2007
    Worked for different International clients such as Belgacom, Sony Pictures Home Entertainment, Somerfield etc. Achieved Team of the Month award from Belgacom, achieved MCAD certificate and Project Management Professional(PMP).
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Debarshi Das Skills

Project Management Business Analysis Management Consulting Business Process Clinical Research Clinical Systems Business Strategy Team Management Change Management Management Consulting Gcp Ctms Clinical Operations Financial Services Edc Clinical Development Analysis Microsoft Excel Powerpoint Sql Scripting Html Lean Six Sigma Clinical Systems Implementation Gxp 21 Cfr Part 11 Strategy Requirements Analysis Crm Ich Gcp Vendor Management Project Planning Pmp Business Intelligence Software Project Management Sqa

Debarshi Das Education Details

Frequently Asked Questions about Debarshi Das

What company does Debarshi Das work for?

Debarshi Das works for Keyrus Life Science

What is Debarshi Das's role at the current company?

Debarshi Das's current role is RTSM Project Manager and (ex-)Randomization Officer.

What is Debarshi Das's email address?

Debarshi Das's email address is ri****@****hoo.com

What schools did Debarshi Das attend?

Debarshi Das attended Emlyon Business School, Cll, Jadavpur University.

What are some of Debarshi Das's interests?

Debarshi Das has interest in Networking, Children, Economic Empowerment, Education, Poverty Alleviation, Organising, Disaster And Humanitarian Relief, Human Rights, Driving.

What skills is Debarshi Das known for?

Debarshi Das has skills like Project Management, Business Analysis, Management, Consulting, Business Process, Clinical Research, Clinical Systems, Business Strategy, Team Management, Change Management, Management Consulting, Gcp.

Who are Debarshi Das's colleagues?

Debarshi Das's colleagues are Gaël Talbi, Joanna Kabi, Laurence Autran, Mariia K., Snoeck Anne, Nassima Messal (Phd), Maxime Magis.

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