Senior Clinical Trial Manager
Core
Oversees and collaborates with study team members and cross-functional stakeholders to ensure timely and on-budget execution of clinical trial deliverables.
Role type
Senior Clinical Trial Manager
Builds
Clinical trials for innovative medicines
Domain
Biopharmaceuticals / Clinical Research
Required skills
Risk management, Regulatory compliance, Vendor management, Site evaluation, Protocol registration, CAPA leadership
Responsibilities
Oversees and collaborates with study team members and cross-functional stakeholders to proactively identify opportunities and manage and mitigate risks and to ensure timely and on-budget execution of clinical trial deliverables; Supports internal audit and inspection activities and contributes to corrective and preventive actions (CAPAs), including leading the resolution of issues when appropriate; Monitors updates throughout a study's lifecycle for compliance with regulations and standard operating procedures (SOPs), including contract research associate (CRA) compliance with study parameters and tracks escalation and closure of action items noted in monitoring visit reports during late phase studies including registration of protocols; Monitors progress of clinical trials and identifies and resolves any issues or risks that may impact timelines or study outcomes; Serves as the key operational contact for clinical studies, providing oversight for the site evaluation, initiation and close-out visits in addition to routine monitoring visits; Participates in contract research organization (CRO) and vendor selection and manages all interactions and deliverables from relevant CROs and vendors under the guidance of leadership.