Clinical Trial Specialist (m/f/n) – Freelance – on hold

  • Position zu besetzen ab 4. Juli 2022
  • Permanent-ID FL-1881
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 7x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Project description:
Currently the startup times of clinical trials have to be reduced to an overall 3.5 months until 75 % of the patients are recruited. Onboarding of vendors is a key impediment in achieving that goal.
The service is requested as part of the Vendor Management CD&O. The project has the purpose to establish vendor relationships for clinical trials. The value for BI is established by shortening the overall startup timelines of the particular clinical trial.

Task:
• Establish a trial vendor engagement plan (according to BI requirements and templates) based on clinical trial protocols and elicitation of requirements in dedicated meetings with the trial team
• He/She hands in the plan for review and later approval
• Based on the review feedback by the BI Clinical Trial Leader, the contractor implements the changes and leads the document to approval by BI.
• He/she coordinates the suppliers for the trial, this includes, but is not limited to (details to be found in the Vendor Engagement Plans and respective SOPs):
o Tracking of Suppliers used and main contacts and Issues
o Preparing Trial Oversight Plans
o Train Trial Teams in Vendor Use
o Issue orders when required
o Establish operational system access
o File vendor documentation archival in the TMF
• Performs detailed cost calculation tasks and operations for CD&O services as outlined in the Vendor Engagement Plan conducted in Boehringer Ingelheim
• Performs proactive cost tracking and monitoring of cost development for specific CD&O services for services as per Vendor Engagement Plan
• Sets-up accruals for global processes at the end of the year in as per Vendor Engagement Plan
• Processes service costs‘, pass-through costs‘ as well as patient reimbursement invoices worldwide as per Vendor Engagement Plan
• The contractor shall under no circumstance approve invoices, purchase orders or payments
• The performance of the contractor has the goal to operationally enable the assigned trial teams with vendor services

Requirements
• Experience in the planning/conduct of clinical trials in roles such as clinical project lead, clinical trial coordinator/trial vendor manager
• Experience in project management
• Ability to interact in an international context
• Excellent negotiation skills
• Understanding of GCP
• Experience in budget management and cost control
• Fluent in English, Excellent communication skills
Additional Information
Location: Biberach
Project start: asap
Duration: 12 months
Availability: 4-5 days; ~ 40h / week
Remote: tbd. (mainly remote)

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