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.
What we offer:
Job description:
✓ Ensures the implementation, monitoring and compliance with deadlines on various projects on Data Management activities from study set-up to database freeze,
✓ Defines and implements quality, security and compliance standards to guarantee data integrity and availability according to expectations and usage contexts,
✓ Contributes to, supervises and organizes Data Management activities conducted by CROs,
✓ Coordinates interactions between CROs and project teams related to Data Management activities,
✓ Contributes, reviews and approves study documents: Data Management Plan (DMP), Data Filling Guide, Data Validation Plan (DVP), Data Review Plan (DRP), External Data Transfer Specifications,
✓ Coordinates the design and updating of the Case Report Form (CRF), implementation of the eCRF including annotated CRF and specifications, verification of the database, input screens and consistency tests,
✓ Reviews all or part of various study-related documents such as synopses/CTOs, protocols and study reports,
✓ Quality control, sometimes created as part of internal data reviews, reviews and approves all or part of various biometrics deliverables such as listings to support data review, coding and reconciliation,
✓ Supervises data collection and contributes to the validation, review and reconciliation of study data,
✓ Ensures that activities leading to database freeze are tracked and documented,
✓ Ensures that eTMF is maintained,
✓ Represents data management in all project meetings,
✓ Ensures that Data Management activities are performed in compliance with ethical and quality standards (, ICH/GCP guidelines, international and national regulatory requirements),
✓ Provides data management expertise to optimize project management,
✓ Contributes to the selection of CROs,
✓ Contributes to the updating of quality documents and standards within its scope of activity.
Minimum Requirements :
✓ 10 years’ experience in clinical data management with a minimum of 5 years in eDC in at least one of the following systems: Medidata Rave, TrialMaster, Ennov, Veeva Vault,
✓ Solid experience in all aspects of DM processes (UAT, data cleansing, control definition, data review, data transfer management, reconciliations),
✓ Data Manager in pharmaceutical laboratories, biotech companies or CROs,
✓ Supervision of CROs concerning data management activities for clinical studies,
✓ Significant knowledge of CDISC – CDASH – SDTM,
✓ Knowledge of coding dictionaries such as MedDRA, WHODrug,
✓ Experience in eCRF design and SAS programming is a plus,
✓ Working knowledge of good practice regulatory guidelines (GCDMP, ICH…),
✓ Fluent written and spoken English.
