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Senior Officer - CDM

Date: Nov 29, 2018

Location: Bangalore, IN, 560052

Company: Teva Pharmaceutical Industries Ltd.

Company Info

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.  Join us on our journey of growth!

Job Description

Responsibilities

  • Reporting to Senior Executive/ Assistant Manager/ Deputy Manager – CDM on all data management related activities of Teva Pharmaceuticals -  Bangalore.
  • Review Study protocol and Case Report Forms.
  • Preparation and review of DVS (Data Validation specification).
  • Preparation and review of manual listings for the study.
  • Preparation and review of eCRF Completion guidelines for the study.
  • Preparation and review of Time and Event schedule for the study.
  • Creation and review of UAT (User Acceptance Testing).
  • Performing UAT (User Acceptance Testing) of the edit checks for the study.
  • Performing Data Management activities like query management which include, query generation and query resolution.
  • Perform SAE reconciliation and Lab/Vendor data reconciliation.
  • Generating metric reports/ status reports for the DM status for the study and updating it to assistant manager CDM.
  • Perform Dataset review at the time of Database lock.
  • Freeze and lock the data as appropriate in time for the statistical analysis.
  • Documenting of the DM activities/tasks for the project.
  • Updating study status and informing any study related issues to the Assistant Manager/Deputy Manager/Manager/Senior Manager CDM when required for the further action.
  • Prioritize and plan the tasks efficiently to meet the project deliverables in time.
  • Developing eCRF using clinical data management systems.
  • Programming edit checks and deploys study to production.
  • Performing post production changes and assessment of impact on database.
  • To carry out other responsibilities and as when assigned by the management.

Qualifications

  • Must have 3 to 5 years' of work experience in data management/development, creation of CRF, mock shells, SAS programming of TLS.
  • Experience in CRF design, DM Plan, ECRF filling guidelines, assisting sites in data entry, DM cleaning, review, validation and external data reconciliation,
  • Must be certified in Medidata Rave
 

Function

Research & Development

Sub Function

Drug Development and Preclinical Studies

Reports To

In process of validation

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

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