Zurück zur Suche.Stamford Consultants - English - Clinical Documentation Specialist
| Beschäftigungstyp: | Contract |
| Standort: | Basel - Basel-Stadt, Switzerland, 4058 |
| Gehalt: | 6'000 CHF |
| Sprachen: | Englisch |
| Erforderlichen Sprachen: | 1 |
Details für die Anzeigenschaltung
- Name:Stamford Consultants
- Veröffentlichung:13-02-2012
- Code:VR/04541
Task
-Support and advise the Global Clinical Project Management Team members on the preparation of
their clinical (e)Trial Master File for archiving
- Liaise with internal and regional teams to ensure completeness and quality of documents
- Ensure all (e)filing environments are ready on reception of the first original trial documents
- Support the creation of the (e)Trial Master File Table of Contents for new trials
- Ensure documents are scanned, imported, coded, and indexed into the (e)Trial Master File and
reviewed for quality on an ongoing basis
- Plan and perform periodical quality checks of (e)Trial Master Files to identify any filing issues
experienced by the Clinical Trial Teams to ensure the (e)Trial Master Files meet internal and external
quality standards
- Support the trial management teams in the preparation, conduct, and follow up of internal and/or
external audits/inspections
- Communicate all systematic filing issues to manager for further training evaluation
- Maintain an inventory of the clinical (e)Trial Master Files stored in the Global Clinical Project
Management archiving room and a list tracking the status of each clinical trial
- Maintain a list of the clinical (e)Trial Master Files transferred to long term archive, including the actual
transfer date and the responsible person for the transfer
- Other duties, activities, and projects as assigned
Profile
- Bachelors of Science degree or equivalent University education/degree in life sciences or healthcare
preferred
- Minimum of 3 years of clinical research related experience with knowledge of clinical research,
applicable regulations and guidelines
- Strong interpersonal skills; ability to implement team decisions and deal with difficult situations
- Excellent organizational skills; ability to organize own time and the workload of others; able to
coordinate activities efficiently under pressure
- Highly detail oriented and quality conscious
-Support and advise the Global Clinical Project Management Team members on the preparation of
their clinical (e)Trial Master File for archiving
- Liaise with internal and regional teams to ensure completeness and quality of documents
- Ensure all (e)filing environments are ready on reception of the first original trial documents
- Support the creation of the (e)Trial Master File Table of Contents for new trials
- Ensure documents are scanned, imported, coded, and indexed into the (e)Trial Master File and
reviewed for quality on an ongoing basis
- Plan and perform periodical quality checks of (e)Trial Master Files to identify any filing issues
experienced by the Clinical Trial Teams to ensure the (e)Trial Master Files meet internal and external
quality standards
- Support the trial management teams in the preparation, conduct, and follow up of internal and/or
external audits/inspections
- Communicate all systematic filing issues to manager for further training evaluation
- Maintain an inventory of the clinical (e)Trial Master Files stored in the Global Clinical Project
Management archiving room and a list tracking the status of each clinical trial
- Maintain a list of the clinical (e)Trial Master Files transferred to long term archive, including the actual
transfer date and the responsible person for the transfer
- Other duties, activities, and projects as assigned
Profile
- Bachelors of Science degree or equivalent University education/degree in life sciences or healthcare
preferred
- Minimum of 3 years of clinical research related experience with knowledge of clinical research,
applicable regulations and guidelines
- Strong interpersonal skills; ability to implement team decisions and deal with difficult situations
- Excellent organizational skills; ability to organize own time and the workload of others; able to
coordinate activities efficiently under pressure
- Highly detail oriented and quality conscious
Due to the nature of this position, the recruiter has requested to restrict applications by location. Only candidates in Europe (EEA) may apply.
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