Senior Clinical Data Manager

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Job description

Senior Clinical Data Manager

Posted on : September 15th

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 800 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

 

Mission

Key contact for client Data Management for any study responsible, ensure projects meet study timelines. Represent Data Management at Study Team meetings/client meetings

Support EDC database build and testing through go live

Drive, organise, monitors and track ongoing data cleaning, data review, discrepancy management and data extractions for review committees, interims and database lock

Determine the randomisation scheme and ensure that it is carried out correctly by the IRT

Support eCRF design using CDASH and programming of SDTM output where required

Write, review and approve study Data Management documents using agreed templates per Excelya Group SOPs or client SOPs

Manage external data including preparation of Data Transfer agreements, data reconciliation, loading, secure storage and archiving per client requirements

Ensure that data coding is performed in WHODrug or MedDRA versus client requirements

Review and generate study metrics and status reports within and across several studies

Vendor management and oversight of client service providers DM activities

Profile

Higher education (BSc, MSc, PhD in life sciences or technical)

At least one year DM experience for Data Manager, 3+ years for lead Data Manager

Proficient in one of the leading Data Management systems: Veeva CDMS, Medidata RAVE, Oracle Inform/Clinical One or equivalent

Knowledge of clinical trials phase 1 through post marketing

Understanding of GCP and GDPR

Good level of English (written and oral)

Soft skills: Autonomy, teamwork, interpersonal skills and leadership

Home or office based positions across Europe

If you want to join an attractive CRO which develops and retains talents, don’t hesitate and join us!

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