Ing. KOTESWARA NAIK

is working from home. 🏡

Angestellt, Expert Clinical Data Specialist, Merck Group

Bangalore, Indien

Über mich

Dear Team, While I have been looking for a big leap in my next career move, I have heard about the job posting related to Clinical data Management. Having 9 years of experience in Clinical data Management as an author and quality control specialist (giving me varied skills), I have gained the ability to produce a high-quality deliverable within stipulated timelines utilising effective project management skills. I believe this position in your organisation will be an ideal fit for my skills and I know I can excel as a part of your CDM team. I am a highly motivated, creative individual driven by my passion for sharing my knowledge with my peers. Given an opportunity I am confident that I can prove to be an asset to your organisation. I look forward to your response, I have acquired the key technical and interpersonal skills required for successful completion of multiple projects in parallel, such as delegating, motivating, communicating, and understanding team dynamics.

Fähigkeiten und Kenntnisse

Clinical Data Management
RaveTM
OC RDC
Medrio
Clinical Research
Clinical Trials
Clinical Trial Management
Clinical Data Processing
Clinical Data Interchange Standards Consortium

Werdegang

Berufserfahrung von KOTESWARA NAIK

  • Bis heute 2 Jahre und 11 Monate, seit Juli 2021

    Expert Clinical Data Specialist

    Merck Group

    • Solves moderate to high complexity problems based on advanced to sophisticated analytical skills and complex judgement. • Works effectively in a mixed environment and uses best practices and knowledge or even interpretation of internal and external business issues to improve products or services and to define processes and standards.

  • 2 Jahre und 7 Monate, Jan. 2019 - Juli 2021

    Associate Data Team Lead

    IQVIA
  • 1 Jahr und 8 Monate, Juni 2017 - Jan. 2019

    Senior Clinical Data Manager

    ICON plc

    • Serve as primary point of contact for customer on data management deliverables • With guidance, create and/or review and sign-off on all data management plan (DMP) documents. • With minimal guidance, provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise.

  • 1 Jahr und 4 Monate, Nov. 2013 - Feb. 2015

    CDC study builder

    Quartesian clinical research

    • Protocol Reviews • Database Design • User Acceptance Testing • Edit Check Preparation • Edit Check programming • Test Date Preparation • Test Date Entry • Database Inside and Outside Medrio Testing • Medidata Rave Data Base Designing, Edit Check Specification Preparation and testing. • CDSIC- SDTM (eCRF Annotation).

  • 1 Jahr und 6 Monate, Juni 2012 - Nov. 2013

    Clinical Data Entry Associate

    Genelife Clinical research

    • Performed the data entry into database. • Designing the CRF as per the protocol and CRF completion guidelines and annotating CRF detailing the database attributes • Review, analyze, and validate clinical trial data in CRF for consistency, integrity and accuracy based on project specific guidelines • Perform User acceptance test (UAT) for Database validation

Ausbildung von KOTESWARA NAIK

  • 4 Jahre und 1 Monat, März 2008 - März 2012

    Bachelor of Pharmacy

    Acharya Nagarjuna University

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