Clinical Trial Specialist (m/w/d) (PR-33377527) München, Deutschland

Aplitrak - München - 05-04-2020 zur Vakanz  

Clinical Trial Specialist (m/w/d)

You have 1-3 years of professional experience as a Clinical Trial Assistant (CTA) and are looking for the jump to a biotechnology company in Munich?

Then this is exactly the right position for you:

Your Responsibilities:
  • Work in collaboration with the Clinical Trial Leader (CTL) and contribute to the conduct of the clinical trial by:
  • Coordinating and participating in Clinical Trial Team (CTT) meetings, prepare meeting minutes and track / follow-up on outstanding actions
  • Ensuring all operational trial deliverables are met according to timelines, budget, operational procedures and quality standards
  • Preparing trial outsourcing specifications and participate in the vendor selection process
  • Setting up and maintaining trial-related processes and systems (e.g., central laboratories, interactive response technologies (IRT), clinical supplies) with vendors as per protocol requirements
  • Overseeing EC/IRB submission activities conducted by CRO
  • Managing Trial Master File (TMF) and ensuring implementation of TMF management plan and QC plan
  • Managing interactions with the CTT and vendors
  • Planning investigator meetings or equivalent investigator training and monitor trainings
  • Collecting and tracking trial status such as enrollment and timelines for updating the relevant internal / external boards
  • Ensuring accuracy of trial information in all trial databases, TMF, and tracking systems
  • Coordinating trial close out activities and ensuring completion of final drug accountability
  • Ensure inspection / audit readiness including TMF documentation and participate in internal audits and inspections as required
  • Contribute to process improvement or acts as Subject Matter Expert for training or SOPs
 

Your Requirements:
  • Ideally at least three years of experience in Clinical Trials
  • Good knowledge of Good Clinical Practice
  • Familiar with clinical trial and drug development processes
  • Ability to work in a matrix organization and demonstrated collaboration skills
  • Effectively prioritize workload
  • Fluent English, both written and oral 
  •  

Details:
  • Earliest start: immediately
  • Workload: full-time (40 hours/week)
  • Location: Munich area
 
Have we aroused your interest?
Then apply as a Clinical Trial Specialist (f/m/d) with your current CV - a cover letter is not required. If you have any questions, please contact Ms Laureen Stooß from Progressive at 0176 55734164 or l.stooss[at]progressive.de.

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zur Vakanz

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