Technical Data Manager II – India

Excelya>All job opportunites>Full-time, Permanent Contract>Technical Data Manager II – India

Job description

Excelya is 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.

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

The role:

Exceya is looking to collaborate with a full-time Technical Data Manager based in India. Excellent knowledge of the English and local language are required for this role.

The Technical Data Manager is responsible for performing Technical Data Management tasks per client work orders to high regulatory standards and Excelya Group SOPs.

General Responsibilities/Tasks:

1. Deeply acknowledges and strictly follows Excelya and Client’s SOPs, guidelines and appropriate local and international legislation.

2. Responsible for CRF design (Unique) in the EDC database, screens design, Data Validation Plan writing, edit checks programming in EDC database, and writing listings specifications.

3. Work closely with the Lead Data Manager responsible for the study.

4. Responsible to maintain global libraries in EDC database.

5. Participate to study documentation archiving.

6. 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 Excelya.

Education and Experience

  • Bachelor’s degree qualification in a Scientific discipline is preferred
  • Three or more years as a Technical 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)
  • Ability to travel as necessary (up to 25%)

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