Description
You will be responsible for:* Coordinating the development and implementation of databases for all assigned trials (including testing activities):
* Clinical protocol review
* Design and set-up of data collection documents
* Database specifications
* Edit Check Specifications
* Reports Specifications
* Management / coordination of data management tasks and trial conduct under paper/EDC process; this includes quality control activities (e.g. databases, scanning, archives):
* Data validation (cleaning) under Inform V4.5 and V4.6
* Data batch loading of external data (serology ? immunology, IVRS..)
* Data reporting, Data Review/Medical Safety Reviews with internal reporting tools (SAS)
* Trial Document management within Clinical eDoc and archiving/Trial Master File (TMF) management
* Regular technical point/feedbacks between the Data Manager and the Project Data Manager and/or DMG Platform Head will be done to assess the trial advancement status by regular face to face meetings
* Coordination of production activities and follow up of database revisions
* QC of TMF, management of CRF on PDF format including QC, reconciliation activities
You will be able to meet the following requirements:
* Minimum of 5 Years experience in the pharmaceutical field
*Proficiency in relevant systems. We are interested in experience of one or more of the following: Oracle Clinical, Oracle Clinical RDC Onsite, InForm and/or Medidata Rave.* Track record of leading studies through the data management life cycle.
* Excellent interpersonal, communication (written and verbal) and organisational skills.
* Possess a positive attitude and work well within local and global teams.
* Awareness of applicable regulatory rules and guidelines.
* Degree in a related field or an appropriate combination of relevant education and experience.
If you are interested in this role, have any questions about this position or would like to register your interest in other positions, please feel free to send your up to date CV or contact me on Sthree UK is acting as an Employment Business in relation to this vacancy.