Lead clinical trial execution across the site network, overseeing study start-up, activation, and ongoing operational performance.
Serve as the primary operational liaison for Sponsors and CROs, providing regular updates on study progress, risks, and mitigation strategies.
Act as a central resource for site teams, resolving operational and protocol-related challenges and driving timely solutions.
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted, healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.
Act as Local Contact Person for Pharmacovigilance for the designated country.
Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables.
Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
Prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications and successfully open/close studies from inception to accrual.
Emory University is a leading research university fostering excellence and attracting world-class talent to innovate today and prepare leaders for the future. They welcome candidates who can contribute to the excellence of their academic community.
Collaborate with Clinical Operations, Clinical Development, and other departments on Risk Based Quality Management.
Identify and evaluate the remediation of fundamental risks and quality issues at vendors and clinical sites.
Develop and implement inspection readiness plans and procedures for Health Authority inspections.
Kailera develops therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, Kailera is expanding and seeking talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join the team.