Allucent
pharmaceuticals and biologics
Sr.ClinicalResearchAssociate(Germany)
“Sr. Clinical Research Associate (Germany) at Allucent. Skills: Clinical Research Associate, monitoring expertise, regulatory affairs, site activation. Independently control and monitor investigational sites. pro-actively detect issues”
Industry & Context.
provide solutions; Identify and resolve site issues
Travel throughout Germany., Willingness to travel, as required (8 DOS per month).
What They're Looking For.
Must Have
Experience leading monitoring activities in complex trials, ideally in oncology or rare disease with a minimum of at least 5 years’ experience., understanding of ICH-GCP and regulatory guidelines., Clear and confident communicator in English and German., Comfortable working independently and managing priorities., Willingness to travel, as required (8 DOS per month).
What You'll Do.
Independently control and monitor investigational sites
pro-actively detect issues
provide solutions to ensure clinical studies are performed according to the trial protocol and in compliance with SOPs
applicable regulations
and the principles of Good Clinical Practice
take the lead on monitoring activities
owning your sites and relationships with investigators
bridge between sponsor and site
ensuring trial integrity
Independently manage all aspects of monitoring for assigned clinical trials across study phases
including site initiation
and close-out visits.
Ensure compliance with protocols
and applicable regulatory requirements.
Build site relationships
acting as a primary point of contact and ensuring high-quality data collection.
Identify and resolve site issues
escalating as needed to maintain trial integrity and patient safety.
Activities around regulatory affairs
site activation and study-startup.
How You'll Work.
Team & Collaboration
forge meaningful partnerships with clients; collaborate with top minds across science, business, and operations; supported by a collaborative, experienced team; thrive in an agile, collaborative environment
Communication Scope
Clear and confident communicator in English and German.
Process & Methodology
Independently manage all aspects of monitoring for assigned clinical trials across study phases
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