layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Clinical Trial Manager at Kardigan | LAYIQ

Supports the Clinical Trial Lead (CTL) in the oversight and management of study CROs to ensure that the study(ies) are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
Coordinates and contributes to the review of relevant study plans and documents including protocols, informed consent forms, project management and monitoring plans, vendor study documents
Responsible for management of select study vendors including review of vendor study operational plans, key performance metrics, risks identification and mitigation
Proactively escalates issues to the Clinical Trial Lead to ensure timely resolution of issues and overall inspection readiness
Develops and coordinates the review and maintenance of vendor oversight plans in conjunction with the Clinical Trial Lead and other trial team members
Supports the Clinical Trial Lead in planning and maintaining study timelines, ensuring the cross functional project team remains on track for project and study deliverables
Actively participate in CRO and vendor meetings and study execution meetings
Support the operational strategy related to assigned vendors, data flow, drug supply, remote patient monitoring and any/all decentralized trial processes
Tracks, monitors and reports on study progress
Manages CRO and vendor budgets and invoicing procedures according to study contract
Summarizes CRO and vendor performance data and escalates risk to the Clinical Operations Program Lead and/or Head of Development Operations, as needed
Responsible for maintaining Action/Decision and Issue/Issue Resolution logs for assigned CRO/vendor management
Ensure CAPAs are in place, if applicable
Contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
Here’s what you’ll bring to the table
BA/BS with 7+ years of experience in global clinical trial management roles from pharmaceutical companies and/or CROs
Experience within the field of cardiovascular studies and/or rare disease is desirable
Experience in early and late stage drug development; late-stage development is desirable
Independent professional who proactively communicates frequently and effectively
Detail and action-oriented, organized and committed to quality and consistency
Ability to work successfully in cross-functional teams
Ability to work in a dynamic environment with a high degree of flexibility
Expertise in Microsoft Smartsheets desired
Experience in ICH/GCP inspections, audits and inspection preparedness
20% of travel required
Exact Compensation may vary based on skills, experience and location.

Clinical Trial Manager

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