Coordinate clinical trial site activities and support successful site start-up and activation.
Serve as a primary point of contact for investigative sites, facilitating communication among clinical teams, sponsors, CROs, and regulatory stakeholders.
Ensure compliance with ICH/GCP guidelines, manage essential documentation, regulatory submissions, and site activation milestones.
This role is listed on behalf of a partner company in the clinical research sector, focused on coordinating site start-up and activation for clinical trials. The culture emphasizes operational excellence, collaboration, and patient safety, with a remote working environment.
Lead clinical study strategy and execution for regulatory approvals and evidence initiatives.
Partner with stakeholders, investigators, and KOLs to design protocols and manage study progress.
Oversee monitoring, compliance, and data analysis while mentoring junior staff.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, known for da Vinci and Ion systems. Its team of engineers, clinicians, and innovators works to make surgery smarter, safer, and more human.
Execute the clinical audit program, including scheduling, planning, reporting, and resolution of audits.
Ensure compliance with worldwide regulations, ICH-GCP, AbbVie policies, and sponsor requirements.
Provide advice and support on GCP and quality topics to business partners and support inspections.
AbbVie discovers and delivers innovative medicines and solutions across immunology, oncology, neuroscience, and aesthetics. It is a large biopharmaceutical company committed to integrity, innovation, and community service.