The Clinical Trial Manager (CTM) will be accountable for the operational management of the regional/local component of clinical trials. As CTM, you will maintain oversight to ensure the achievement of trial recruitment commitment, timelines, budget and internal/external quality standards.

Accountabilities

Trial Preparation, Conduct and Closeout:

• Selected sites conduct and deliver the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH-GCP and all other relevant external regulations
• Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts and necessary approvals
• All Regulatory requirements are satisfied prior to trial/site initiation
• Where necessary, set up and manage external suppliers that meet requirements of local/regional trial operations
• Set up, manage and review UK & Ireland trial budget to ensure appropriate level of financial oversight
• Timely budget updates based on trial changes
• Ensure appropriate trial-specific training of UK & Ireland internal and external partners in line with Trial Training Plan
• In collaboration with Site Monitoring Lead and CRAs, ensure provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and team to GCP, local regulations, SOPs and adherence to trial protocol
• Ensure adequate trial supply distribution to sites
• Trial contact for CRAs, investigators and site staff
• In collaboration with Trial Records Specialist and with supports from CRAs as appropriate, ensures collection of required documents, with timely, complete and compliant archiving of all relevant documents for the eTMF and CTR Appendices

Management and Relationship Responsibilities:

• Develop and maintain company relationships with external experts and investigational sites by coordinating and ensuring cross-functional collaboration amongst Clinical Operations and Medical Affairs on Regional/ local level and supporting CRAs in site contacts
• Collaborates with other functions to support Trial Management topics and support integration across Medicine
• Participate in working groups related to Trial
• Represent Trial on local and regional level, providing updates on trial within UK & Ireland
• Provide mentoring to other members of the department as assigned

Regulatory and Organizational Requirements:

• Ensures all tasks are carried out in accordance with respective applicable SOPs, Business Practices and regulatory requirements
• Ensures that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with sponsor Values

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com