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Summary

Dear Hiring Manager,

I am Mantosh Kumar Mohanta. I have overall 8 years of experience in Contract Research Organization (CRO).  I am well experienced in Data Management for 6 years with good exposure to diverse therapeutic areas (Oncology, Ophthalmology, Gastroenterology, Orthopedics, Transplant and Dermatology) and hands on experience in Study Start-up, Conduct and Close-out activities.

 

Involve in Project Management in terms of resource forecasting and creation of Milestone Planner for Deliverables like DMC, DSUR, Interim Lock and Database lock.

I am proficient working on various platforms like Medidata Rave and DataLabs and currently working as Clinical Data Analyst III (Study Team Lead) in PAREXEL International.

Please let me know if my profile suits your requirements.

Waiting to hear back from you.

Thanks and Regards,

Mantosh Kumar Mohanta

Experiences

Current Experience

  • Clinical Data Analyst III (Study Team Lead) Hyderabad, Telangana, India
    Since November 2014

    • Acting as Study Team Lead for 3 studies.
    • Manage all phases of Data Management activities from study start up to database close.
    • Development of eCRF Specification, Data Validation Plan, Protocol Deviation Specification, Data Cleaning Specifications, eCRF Completion Instructions, SAE reconciliation Guidelines etc. and attending Sponsor Acceptance Meeting (SAM meeting).
    • Review Coding Definition Document and Coding Configuration Document created by Primary Coder.
    • Involve in Project Management in terms of resource forecasting and creation of Milestone Planner for Deliverables like DMC, DSUR, Interim Lock and Database lock.
    • Test data creation & UAT.
    • Integration testing of external tools with that of Database (e.g. IWRS, PD Tool, SAE Tool etc).
    • Performing/ leading functional QC activities and testing.
    • Data validation and cleaning.
    • Creation of Offline Listing and Review (PK, IVRS,ECG, etc).
    • Conduct SAE & third party data reconciliations.
    • Perform early and final database QC activities.
    • Database lock activities.
    • Adhering to global as well as study specific conventions.
    • Responsible for completeness, timely delivery and quality of clinical data.
    • Coordinating with overseas CDM team via. E-mail and teleconference.
    • Liaise with various PAREXEL Stakeholders like Database Programmers, Coders, Clinical (Monitors), Medical Monitors, Statistical Programmers, and Project Leaders.

     

Past Experience

  • Clinical Data Analyst II Hyderabad, Telangana, India
    June 2012 --- October 2014

    • Acting as a Study Point of Contact (SPOC) for three studies.
    • Performing data management activities including discrepancy review, query generation and resolution.
    • Cleaning of the database based upon the SAS and J-Review manual listings.
    • Writing database validation specifications working in parallel with the programmer and the Primary Clinical Data Associate (PCDA).
    • Database validation (DB-UAT) against the specified e-CRFs.
    • Edit Check validation (EC-UAT)-validation of the programmed checks by creating test cases for the Pass and the Fail conditions in the testing database.
    • SAE Reconciliation for maintaining the consistency of the SAEs reported in the Safety and the Clinical Trials Database.
    • Reconciliation of data received from external sources (e.g. Lab data etc).
    • Identifying and raising protocol deviations (PDs) in the Database.
    • Freezes eCRF data and performs lock of subject information.
    • Manual review of the data by pulling out reports from the standard reporters.
    • Study start-up activities-including communication with the Sponsor and the Data team leads.
    • Create CRF Completion Guidelines (CCG), SAE reconciliation Guidelines, etc.
    • Performing quality control procedures in the team.
    • Perform early and final database QC activities.
    • Interface with PAREXEL Clinical & Data Monitoring, Safety & Pharmacovigilance, Biostatistics or other PAREXEL personnel as necessary to answer project questions and resolve data issues.
    • Planning for the resources with guidance from the manager.
    • Mentoring and supporting the new staff technically and morally.

  • Clinical Data Associate II Gandhinagar, Gujarat, India
    April 2010 --- June 2012

      • Apply corrections and/or updates to the clinical database for EDC studies using appropriate documents (original and/or working copies of CRFs and Study documents-DMP, DVP and other relevant data cleaning documentation).
      • Generate and/or review listings to check accuracy and completeness of clinical data.
      • Coordinates receipt, handling, and reconciliation of data received from external sources (e.g. Lab data etc) where applicable.
      • Interface with Kendle Clinical & Data Monitoring, Safety & Pharmacovigilance, Biostatistics or other Kendle personnel as necessary to answer project questions and resolve data issues.
      • Contribute to the project team by suggesting conventions, electronic/manual checks, listings and process improvements which maximize efficiency of data cleaning.
      • Perform start up activities such as Screen Testing, UAT testing/Integration testing.
      • SAE Reconciliation for maintaining the consistency of the SAEs reported in the Safety and the Clinical Trials Database.
      • Freezes eCRF data and performs lock of subject information.
      • Assists in monitoring quality of work performed by CDM project team and compliance with SOPs and provides feedback to team and CDM management as appropriate.
      .

  • Clinical Data Associate I Gandhinagar, Gujarat, India
    April 2010 --- March 2012

    • Performing data management tasks including discrepancy review, query generation, resolution and quality control activities.
    • Database validation (UAT) against the specified e-CRFs.
    • Cleaning of the database based upon the SAS and J-Review manual listings.
    • Manual review of the data by pulling out reports from the standard reporters (J-review).
    • Carry forwarding the data issues to the Team Lead & communication within project team.
    • Performing Reporting activities (Missing and Overdue pages) to the sponsor.
    • Coordinates reconciliation of data received from external sources (e.g. Lab data etc.) where applicable.
    • Freezes eCRF data and performs lock of subject information.

     

  • Strategic Site Relation Specialist-I Gurgaon, Haryana, India
    June 2008 --- April 2010

    • Collects feasibility information in support of current (Request for Proposal) RFPs, and circulate as required.
    • Assists with preparation of material for bid defense meetings.
    • Assists with design of study specific questionnaires for collection of metric-based global feasibility information for individual countries, sites, patient populations, etc.
    • Performs research of scientific literature using the internet and internal facilities to provide background information for proposal submission and feasibility reports.
    • Liaises with internal and external personnel to coordinate the collection of feasibility data.
    • Collects specific ethics and regulatory data for individual countries as required.

  • Content Wrangler (Médical) Bangalore, Karnataka, India
    July 2007 --- May 2008

    Research on scientific literature, Analyzing live published articles and Tagging key words for appropriate link for the advertisers for different medical and Scientific publications like British Medical Journal, Contemporary Surgery, Current Psychiatry, Obstetrics and Gynaecology, Journal of Family Planning, Medical Imaging, Mayo Clinic Proceedings, Chromatography Online & Chemical and Engineering News.

     

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Personality

Self Assessment :
Analytical thinkingAdaptabilityApproachabilityCollaborationAttention to detailCommunicative

Knowledge

Self Assessment :
Clinical Data Management (CDM)Clinical researchClinical Study DesignCleaning ValidationClinical Trial Management System (CTMS)

Skills and Expertise

Self Assessment :
Design case record formsClinical data collectionCreate clinical documentsCreate clinical project documents according to the protocolCreate study documentsData validationDesign case record form (CRF)Design data collection systemsDesign database Design study documents

Education

  • Master in Biotechnology from Bangalore University in 2007
  • Bachelor in Biotechnology from Bangalore University in 2005

Training and Certification

  • Post Graduate Diploma in Clinical Research and Data Management (Pune University) in 2008 Certification
  • Certificate in Good Clinical Practice (GCP) (GCP Alliance Europe ) in 2007 Certification
  • Intellectual Property Rights (IPR) (The Institute of Bioinformatics & Applied Biotechnology) in 2007 Certification

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency

Work Preferences

  • Notice Period:
    9 weeks
  • Positions I am interested in:
    Clinical Data Manager (DM)
  • Locations I am interested in:
    Austria Belgium France Germany Italy Sweden Switzerland United Kingdom
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Hyderabad, Telangana, India

Others

Driving License
  • No