Description
Hays ist ein weltweit führender Personaldienstleister, der sich auf die Rekrutierung von Spezialisten konzentriert - sowohl für den Projekteinsatz als auch für Festanstellungen und auf Zeit. In Deutschland, Österreich und der Schweiz vertrauen mehr als 600 internationale Topunternehmen auf unsere qualitätsgesicherten Prozesse, wenn Sie Experten suchen.We are looking for a
Clinical Trial Documentation Specialist (m/f)
Referenz: -en
Beginn: asap
Dauer: 12 MM++
Ort: in Basel region
Branche: Herstellung von pharmazeutischen Erzeugnissen
Ihre Aufgaben:
- Support the clinical process of collection, quality control (QC), indexing (pre-coding),maintenance, storage and archiving of all Trial Master File (TMF) documents
- Evaluation of the conduct of a trial/number of trials and the quality of the data producedwithin the Study Master File (StMF), Country Master File (CMF), Site Master File (SMF) and FinancialFile (FF) for a Global Operations Study Team
- Provide support for the creation, implementation, maintenance andcontinued improvement of physical and electronic filing and QC systems for the housing of TMFdocuments
- Ensure availability of study specific Table of Content (ToC) for TMF and Investigator Site File(ISF) prior to study start
- Ensure set-up of templates for tracking/QC checklists prior to study start
- Ensure timely provision of TMF templates and ISF to regional team
- Ensure proper and timely tracking of study documentation and perform regular QCs of the TMFfor completeness and accuracy on an ongoing basis as outlined in the relevant SOPs, processesand guidelines to ensure the inspection readiness at any point in time
- Manage the set up, maintenance and timely archiving (or shipment to HQ, if applicable) of theTMF
- Represent study team to co-ordinate the set-up and ongoing adaptation of ToC. Review and/orprovide input into TMF ToC for new trials, based on the published version of the company´s TMFToC template
- Assess filing process on an ongoing basis to identify improvement opportunities and share on aregular basis document management/filing issues with e.g. Global Operations – DocumentationGroup (GO-DG) and Study Team
Ihre Qualifikation
- Bachelor’s degree in either biological science or health care related field preferred
- Sound experience in clinical research, applicable regulations and guidelines,monitoring experience desirable
- Strong computer skills
- Ability to work as an effective team member
- Excellent oral and written communication skills
- Fluent in English (additional languages advantageous)
- Good organizational skills; able to coordinate activities effectively under pressure
- Highly detail-oriented, quality driven
- Ability to work independently, self-motivated
- Ability to work methodically, systematically and accurately
Skills:
- Clinical Project Management