Trial Start Up Specialist Oncology

Basel-Country  ‐ Vor Ort
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Schlagworte

Beschreibung

Areas of responsibility
  • Tracks and maintains study milestones in ClinAdmin for several Phase I-IV clinical trials during the start up.
  • Make sure that data are promptly and properly reported in ClinAdmin: full consistency with country/regional tools
  • Provide regular updates on trial start up progress and support PARMs to identify and solve specific issues
  • Provide reports on CPO's compliance
  • liasing with key line function that provided documents for the FPP to standarize and simplfy the process where possible.
  • Track CPOs readiness to submit to Health Authorities in a timely fashion.
  • Support PARMs/CTT in managing interactions with relevant line functions including Drug Supply Management and DRA to ensure HA submission, and SIVs occur in a timely fashion
  • Support GMO ARMs group in activities that can be centralized and help bridge gap when possible
  • Inform PARM and CTT when local CTA is submitted to Health Authorities.
  • Follow up with the CPOs to ensure updates to the regulatory requirements regularly.
  • Early identification, communication and escalation to the PARM when the operational aspects are not in place for the CPOs.
  • Maintain the Masterlist of CPO requirements and work with CPOs to keep this current


Ideal Background
  • A working knowledge and compliance with the Good Clinical Practices and Standard Operating Procedures
  • None to basic knowledge of Good Clinical Practice; basic knowledge of scientific principles.
  • At least 1 year of experience with clinical study planning, execution, and reporting
  • Participate in CTT meetings as needed
  • Bachelor degree or equivalent education/degree qualification in life science/healthcare required.
  • Fluent English (oral and written)
  • Good communication, organization and tracking skills.


More Details:
  • 6 Months fulltime
  • Location: BaselArea
  • 100% onsite
  • Start date: a.s.a.p


Please notice: European citizens are preferred

For a confidential discussion about regulatory affairs projects in Switzerland, or to apply, then send your CV to or call me.

I am a specialist recruitment consultant in regulatory affairs for the Pharmaceutical & Biotechnology industry. I offer a number of search options within the industry with a special focus on Switzerland.

If you are a Pharmaceutical professional looking for your next opportunity, then please don't hesitate to get in contact with me. Alternatively if you are currently looking for skilled individuals for the development of your organisation, then I can certainly help.
Your personal contact:

Kristina Bröckel

Regulatory Affairs Consultant

Tel:

mailto:

To find out more about Real please visit www.realstaffing.com
Start
05/2013
Dauer
6 months
Von
Real Staffing
Eingestellt
11.04.2013
Projekt-ID:
519318
Vertragsart
Freiberuflich
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