This position independently leads, manages, and motivates a team of Clinical Trial Managers and Managers to a standard consistent with Precision for Medicine’s values and overall focus on quality. You will ensure studies are conducted in accordance with applicable SOPs, regulations, and ICH GCP principles.
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Act as the primary point of contact for incoming member calls, prior authorization inquiries, and ensure appropriate escalation of cases to the Clinical Prior Authorization Team. Efficiently triage incoming calls with professional phone etiquette from members, prescribers, and pharmacies with minimal support. Ask probing questions to identify and resolve all issues and address concerns promptly.
As a CTA, you will join the world’s largest & most comprehensive clinical research organisation. The Clinical Trial Assistant plays a fundamental role in the successful execution of global clinical trials, supporting the completion and coordination of various logistical and administrative tasks. Responsibilities include collecting data for regulatory submissions, document tracking, and maintaining relationships with site staff.
The Local Country Person Responsible for Pharmacovigilance and Regulatory Affairs serves as the primary local representative to ensure compliance with national pharmacovigilance and regulatory requirements in the United States. This dual-role position is responsible for executing PV and RA activities at the local level, supporting the Marketing Authorisation Holder in maintaining product compliance.
As a Medical Affairs Manager, you will continuously monitor all inquiries to external stakeholders and conduct detailed reviews of each inquiry handled by MI associates. You'll provide feedback to MI associates, develop and maintain response databases, and collaborate with cross-functional teams to support products. Responsibilities also include developing and providing therapeutic and product training to internal customers, monitoring metrics for MI activities, and providing inquiry management coverage.
Perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for client marketed products and clinical trials. Completion of the case management lifecycle including but not limited to: intake, triage, book-in, data entry, peer/quality review, follow-up and submissions. Perform case processing and data gathering tasks within Argus Safety Database and other client systems. Assist with business partner and other query management.