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Clincial Data Manager
Clincial Data ManagerErgomed • Pune, Maharashtra, India
Clincial Data Manager

Clincial Data Manager

Ergomed • Pune, Maharashtra, India
30+ days ago
Job description

The Data Manager within the ERGOMED Data Management (DM) is responsible for database testing query management management of lab reference ranges serious adverse event reconciliation vendor data reconciliation and other tasks related to data management. The Data Manager represents a position under direction of the Manager Data Management and is supervised by the Project Data Manager on a project level.

The Data Manager is responsible for supporting various data management activities from initiation of protocol through database lock data cleaning activities including :

Study start-up

  • Perform validation of EDC Systems and associated DM reports or listings
  • Perform validation of EDC and SAS edit checks
  • Manage and Create EDC user accounts
  • Update and maintain DM documentation as directed by the Lead Data Manager (LDM) or Project
  • Performs specified activities that contribute to the creation of database specifications database build and user acceptance testing during database and edit check development

Study Conduct (Support multiple moderate complexity / complex trials with minimal supervision)

  • May enter Data from trial documents into data entry system
  • May perform Medical Coding
  • Manage the entry review and tracking of Local / Central Lab reference ranges
  • Attend internal / external teleconferences as needed
  • May create and review study metric reports for internal / external project teams
  • Notify management of roadblocks for getting processes done in a timely manner and offer possible solutions
  • Provide the PDM with status updates on tasks that are assigned
  • Escalates significant issues promptly to the study team
  • Study Closure

  • Support the Lead Data Manager with all DM related close-out activities and DBL checklist (query resolution final reconciliations development of reports)
  • Qualifications :

    Bachelors Degree preferably in Live Sciences Computer Science or other related scientific discipline

  • 2-5 years of relevant clinical data management experience in pharmaceutical industry and / or contract research organization and / or similar data management experience in a non-clinical environment
  • Additional Information :

    The position is also available in any of our European locations

    We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds genders and ages can contribute and grow.

    To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.

    We offer :

  • Training and career development opportunities internally
  • Strong emphasis on personal and professional growth
  • Friendly supportive working environment
  • Opportunity to work with colleagues based all over the world with English as the company language
  • Our core values are key to how we operate and if you feel they resonate with you then Ergomed is a great company to join!

  • Quality
  • Integrity & Trust
  • Drive & Passion
  • Agility & Responsiveness
  • Belonging
  • Collaborative Partnerships
  • We look forward to welcoming your application.

    #LI Remote

    Remote Work : Yes

    Employment Type : Full-time

    Key Skills

    SQL,Data Collection,GCP,Master Data Management,R,Data Management,Clinical Trials,User Acceptance Testing,Data Warehouse,SAS,Oracle,Data Analysis Skills

    Department / Functional Area : Data Management

    Experience : years

    Vacancy : 1

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    Data Manager • Pune, Maharashtra, India

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