Technical Data Manager

Excelya>Full-time>Technical Data Manager

Job description

Created in 2014, Excelya is a contract research organization (CRO).
We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates. Our unique one-stop provider service model – leveraging a full-service, functional service provider and consultancy – allows our Excelyates to evolve across a wide range of projects. Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual and operational participation so that together we can be the best in our field. We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique

Mission
The Technical Data Manager is responsible for performing Technical Data Management tasks per Sponsor standards and SOPs:

  • Deeply acknowledges and strictly follows sponsor SOPs, policies and in-structions.
  • TDM1 works under the supervision of more senior staff (Manager or Senior TDM)
  • Senior TDM provides oversight for more junior staff
  • Responsible for CRF design (Unique) in the Clinical One database, screens design, Data Validation Plan writing and edit checks programming
  • Work closely with the Lead Data Manager responsible for the study.
  • Responsible to maintain global libraries in Clinical One database following Sponsor standards
  • Participate to study documentation archiving
  • 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:

The assignment requires the following skills:

  • Bachelor’s degree qualification in a Scientific discipline is preferred.
  • Experience:
    • TDM1: 1 or more years as a Technical Data Manager or equivalent combination of education, training, and experience
    • TDM2: 3 or more years as a Technical Data Manager or equivalent combination of education, training, and experience
    • Senior TDM: 5 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.
  • Knowledge of Oracle Clinical One will be a plus.
  • 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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