Specialist, Clinical Data Quality
Merck
Bangalore, India
2d ago

A career at our company is an ongoing journey of discovery : our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics.

For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.

Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life.

Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role :

An exciting opportunity has arisen to join our healthcare business to support the development of first and best in class specialty medicines for our patients in need.

As a Clinical Data Quality Specialist, you will be working closely together with our Program and Trial Data Managers to drive value creation by assessing the completeness, quality and integrity of clinical data by using data quality surveillance tools (e.

g. Centralized Quality Reports, Outputs and Listings and other computerized systems). You will leverage those tools for applicable studies to ensure key risk indicators (KRIs) are properly defined for risk-based data surveillance in alignment with the Integrated Data Review Plan (IDRP) and other quality documents.

Furthermore, you will support the assessment of the Data Standards Quality of clinical study including datasets, documentation (cSDRG) and define.

xml. Additionally, you will be accountable for establishing and maintaining effective program and study level communications with the respective Program and Trial Data Managers.

Who you are :

  • Advanced degree in Life Sciences (e.g. biology, chemistry, pharmaceuticals), Mathematics, Computer Sciences, or equivalent industry experience
  • Proven experience (minimum 1-3 years) as Clinical Data Manager or Data Analyst in the pharmaceutical / biotechnology industry or in the field of Centralized Clinical Monitoring
  • Strong written and verbal communication skills in English language
  • Results and detail-oriented approach to work, good understanding of programming language, data visualization and proficient Computer Skills e.
  • g. word processing, Excel, PPT

  • Good Knowledge of Clinical Data Management Systems / EDC (e.g. Inform, Medidate Rave, Oracle RDC)
  • CDISC SDTM knowledge as well as comprehensive knowledge of ICH-GCP and major health authority (e.g. FDA, EMA, NMPA, PMDA) regulations
  • Ability to work on multiple projects
  • Location : Electronic City, Bangalore

    Shift : General Shift

    What we offer : With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons.

    We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life.

    Join us and bring your curiosity to life!

    We are committed to promoting a diverse and inclusive workforce. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

    Report this job
    checkmark

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Apply
    My Email
    By clicking on "Continue", I give neuvoo consent to process my data and to send me email alerts, as detailed in neuvoo's Privacy Policy . I may withdraw my consent or unsubscribe at any time.
    Continue
    Application form