Senior Clinical Data Manager

3 weeks ago

Bangalore Urban district, India Excelya Full time

Excelya is one of the leading CROs in Europe, founded in 2014 and headquartered in Paris. Our global team is composed of 900+ experts who understand the critical needs of clients and provide trial solutions across a broad spectrum of therapeutic areas.


We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.


Excelya's vision is to achieve new advances in the field of healthcare and expertise in research development. Our goal is to help our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together and to become the clinical research leader in Europe.


For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field.


We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique projects.


To learn more about us, visit www.excelya.com.


The role:

Excelya is looking to collaborate with a Full Service Provider Senior Clinical Data Manager (Sr CDM) role, based in Bangalore, India.

The Senior Clinical Data Manager, is responsible for performing Data Management tasks per client work orders to high regulatory standards and Client SOPs.


Job General Responsibilities

  • Deeply acknowledges and strictly follows applicable Excelya and Client’s SOPs.
  • Responsible for data cleaning, data review, discrepancy management and data reconciliation activities on the studies assigned to him/her.
  • Work closely with the Lead Data Manager responsible for the study.
  • Generate study metrics and status reports within and across several studies
  • Participate to study documentation archiving
  • Participate in EDC database build and testing through go live.
  • Senior CDM may act as a Lead Data Manager on simple studies
  • Senior CDM provides oversight for more junior staff
  • Complete Excelya administrative tasks as required e.g., timesheets, CV and training updates.
  • May undertake other tasks as they may be assigned from the supervisor that will concern any of the Excelya Group companies.


Requirements


  • Holds a Bachelor’s degree qualification in a Scientific discipline is preferred
  • Five or more years as a Data Manager or equivalent combination of education, training and experience
  • Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance
  • Understanding of recommended CDM best practices and associated documentation.
  • Experience in clinical trial databases and applications, clinical data flow, data review, and eCase Report Form design.
  • Understanding of clinical trials and study lifecycle (start-up, maintenance & closeout)
  • Proficient in computer technology used in an office environment (Word, Excel, PowerPoint, MS Project, etc.)
  • Ability to maintains high level of professionalism, ethics and compliance at all times.
  • Effective verbal and written communication skills.
  • Fluent in local language and English (written and verbal)

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