Site Contracts Manager Jobs

Great opportunity to work with a Biotech Company!

• Supporting negotiations and management of clinical site/investigator contracts (including fees/budgets) and scope changes to insure a cost-effective, expeditious and successful solution to outsourcing needs: Take the Lead on negotiations when necessary.
• Providing instructions and support to the CRO during the negotiation with the clinical sites/investigators.
• Determining an acceptable range of fees and conditions specific to each trial and country and clinical site.
• Tracking and ensuring execution of all clinical site/investigator contracts, as well as distribution and filing.
• Lead negotiation of documents for clinical studies including, but not limited to clinical site agreements and budgets, indemnification letters, power of attorney, confidential disclosure agreements, and other site related documents, agreements and/or statements.
• Ensuring that study timelines are met by collaboratively working with the clinical study teams to manage the CRO and the investigators selected for the clinical studies.
• Collaborating with the CPM regarding support from Legal, IP Legal, Compliance and other relevant stakeholder groups, where needed.

• Bachelors degree and/or Master’s degree
• Significant experience negotiating legal language and budgets as it relates to clinical trial study agreements.
• Demonstrated leadership skills, networking skills, and communication skills.
• Experience in Pharmaceuticals or Biotechnology, and experience managing and/or working with CROs.
• 8 – 10 years of substantial experience with finalization of clinical trial agreements with EU sites specifically in Australia, Belgium, Germany, Spain, Italy, France, UK, Poland, Czech Republic, and US.