In this highly specialized and dynamic role, you’ll utilise your extensive therapeutic knowledge to oversee uniquely-focused clinical studies. Working at the core of clinical research, you’ll be exposed to cutting-edge protocols and experience a dedicated partnership with your team like never before.
Main responsibilities are to:
• Track receipt of investigator-initiated concepts / proposals and early access (EA) requests
• Facilitate communication between Sponsor via collaboration with key TA/Medical staff and complete sponsor qualification process (in collaboration with TA /Medical staff as needed)
• Provide protocol submission package (or open case package for EA) including product specific safety information, details of ISS (or EA) process and requirements to sponsor for protocol review and start-up activities
• Partner with Global Clinical Pricing on budget negotiations and ensure conduct of Fair Market Value assessment
What is required
• BA / BS/ BSc in the sciences or RN
• Experience in oversight of external vendors (CROs, central labs, imaging vendors, etc.)
• Strong investigator-sponsored study experience gained within the industry at a clinical trial manager level.
• Influential and effective communication skills
• Previous experience gained in a biotech, pharmaceutical or CRO company is preferred
• Valid and current UK working eligibility
What is offered
• The opportunity to work with a sought-after company and ISS department
• Structured training and on-boarding
• Permanent and full-time contract of employment 100% dedicated to one client
• Flexibility to work fully home-based
• An attractive salary package
For more detail and to apply, please contact me today!
#pmjob