Clinical Trial Specialist (m/f/n)
Vendor Management Clinical Development & Operations (CD&O)
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.
The scope of services includes the following tasks, which are independently performed by the external contractor:
- 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):
- Tracking of Suppliers used and main contacts and Issues
- Preparing Trial Oversight Plans
- Train Trial Teams in Vendor Use
- Issue orders when require
- Establish operational system access
- 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.
Trial timelines (see BICTMS) are to be kept.