Clinical Data Manager I

1 week ago

Bengaluru, Karnataka, India Excelya Full time

Excelya, one of the leading independent CRO in Europe.

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model - leveraging full-service, functional service provider and consulting - allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

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 project.

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

To learn more about us, visit

The role:

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

Exceya is looking to collaborate with a FSP (Full Service Provider) role of Clinical Data Manager I(CDMI) based in Bangalore, India.

Job General Responsibilities/Tasks:

  • Deeply acknowledges and strictly follows applicable Excelya and Client's SOPs
  • CDMI works under the supervision of more senior staff (Manager or Senior CDM).
  • 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.
  • May participates in EDC database build and testing through go live.
  • Completes 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
  • 1 (one) 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 spoken)

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