We are looking for a sponsor-dedicated Country Start-Up Lead to oversee clinical trial site activation regulatory processes and financial management. This is a well suited role for someone with experience in clinical start-up operations budget negotiations and regulatory compliance and who enjoys working collaboratively to drive progress.
Key responsibilities:
Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
Responsible for managing country deliverables timelines and results for assigned protocols to meet country commitments.
Work closely with internal and external stakeholders including sponsors CROs and site teams to streamline processes.
Negotiate investigator budgets oversee financial forecasting and manage trial-related expenses
Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
Oversight and tracking of clinical research-related payments.
Payment reconciliation at study close-out.
Qualifications:
University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution nursing certification medical or laboratory technology (Fortrea may consider relevant and equivalent experience in lieu of educational requirements).
Strong background in clinical research including a few years in start-up preferably in a lead position
Skilled knowledge of budget and contract negotiations local regulatory environment and submission and approval processes
Fluent in German and in English with effective communication and negotiation skills.
What we Offer:
An hybrid model allowing you to collaborate effectively with your teams (2 days at clients office in Munich and 3 days working from home).
Opportunities for professional development mentorship and career progression.
Work with an industry-leading sponsor and expand your leadership capabilities.
Thanks to our ERGs (Employee Resource Groups) join divers communities that foster inclusion professional development and networking.
Access to mental health support wellness initiatives and fitness programs.
If you are ready to make an impact collaborate with top professionals and bring your expertise to a meaningful role wed love to hear from you!
#LI-GQ1#LI-Hybrid
Learn more about our EEO & Accommodations request here.
We are looking for a sponsor-dedicated Country Start-Up Lead to oversee clinical trial site activation regulatory processes and financial management. This is a well suited role for someone with experience in clinical start-up operations budget negotiations and regulatory compliance and who enjoys wo...
We are looking for a sponsor-dedicated Country Start-Up Lead to oversee clinical trial site activation regulatory processes and financial management. This is a well suited role for someone with experience in clinical start-up operations budget negotiations and regulatory compliance and who enjoys working collaboratively to drive progress.
Key responsibilities:
Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
Responsible for managing country deliverables timelines and results for assigned protocols to meet country commitments.
Work closely with internal and external stakeholders including sponsors CROs and site teams to streamline processes.
Negotiate investigator budgets oversee financial forecasting and manage trial-related expenses
Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
Oversight and tracking of clinical research-related payments.
Payment reconciliation at study close-out.
Qualifications:
University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution nursing certification medical or laboratory technology (Fortrea may consider relevant and equivalent experience in lieu of educational requirements).
Strong background in clinical research including a few years in start-up preferably in a lead position
Skilled knowledge of budget and contract negotiations local regulatory environment and submission and approval processes
Fluent in German and in English with effective communication and negotiation skills.
What we Offer:
An hybrid model allowing you to collaborate effectively with your teams (2 days at clients office in Munich and 3 days working from home).
Opportunities for professional development mentorship and career progression.
Work with an industry-leading sponsor and expand your leadership capabilities.
Thanks to our ERGs (Employee Resource Groups) join divers communities that foster inclusion professional development and networking.
Access to mental health support wellness initiatives and fitness programs.
If you are ready to make an impact collaborate with top professionals and bring your expertise to a meaningful role wed love to hear from you!
#LI-GQ1#LI-Hybrid
Learn more about our EEO & Accommodations request here.
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