Sponsor Dedicated Global Sr CTM - Home Based in SPAIN. Vendor experience

Overview

Home-based Sr Clinical Trial Manager supporting the management of global and multi-country studies and multiple types of vendors, with vendor experience required.

What you'll do

• Support the development and review of the Clinical Study Blueprint (CSB), Protocol, and all amendments and/or administrative changes.
• Manage the execution of CDAs; support Project Managers in creating the overall study budget with the contract/budget analyst; support site contract amendments and negotiation; manage invoices.
• Assist in developing the Investigator Site Selection Plan; attend country and site selection Jams; assist with the Feasibility Questionnaire, site selection and Green Light Letters, if applicable.
• Stay informed of progress with CDAs, CSAs and site budgets; support sites with contract amendments and assist with site contract negotiation.
• Oversee site payments and vendor payments, if applicable.
• Draft and facilitate the Clinical Study Budget review and study budget financial reconciliation.
• Support the planning, finalization and update of clinical study timelines and manage the study team to meet all timelines.
• Assist in creating and finalizing study-specific training (TA training, compound, study design, vendors, eligibility, etc.); facilitate training sessions; assign training as appropriate; assist with Study Monitor Training materials.
• Assist the Project Manager in planning the Investigator Meeting, collecting slides from all functional areas into the final master deck, presenting at the IM, and filing training documentation.
• Review updates to the Data Management Plan; drive study completeness for Interim/Final Database Lock preparation.
• Develop and maintain the Site Selection Plan, Study-Specific Issue Management Plan, Vendor Oversight Plan, and TMF Artifact Map and Plan.
• Assess and review materials from external vendors (lab kits, ePRO devices, eConsent tablets, etc.); responsible for overall study reconciliation of investigational product.
• Assist with vendor selection; create and manage a Vendor Oversight Plan for each vendor; review vendor contracts, work orders and change orders; provide day-to-day vendor oversight.
• Create review committee charters, assist with member selection, contracting as needed, and update the Annual Plan.
• Develop the site closure plan.
• Assist Project Managers in developing the patient recruitment strategy and plan, develop recruitment materials, and drive strategies for needing new sites.
• Support customization of study/country/site-specific documents; upload documents referencing the Master File Index; oversee TMF health, reconciliation, archival and quarterly TMF review.
• Perform initial Risk Assessment and Mitigation Plan (RAMP) and maintain it throughout the study; manage issue management throughout the study and conduct quarterly issues review.
• Build the study-specific ICF incorporating appropriate study-specific and safety language.
• Assist with CTA submissions and approvals, including agency responses.
• Conduct clinical study team meetings and vendor meetings; responsible for agendas and meeting minutes.
• Keep the CTMS updated at study level.

What you'll need

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
• 5 years or more of experience as CTM, managing multiple countries, for regional or global trials.
• Proven vendor management experience.
• Global study management experience.
• Experience in Oncology clinical trials.
• Strong experience reviewing and overseeing study plans and study-related documentation.
• Demonstrated ability to lead and align teams in the achievement of project milestones.
• Demonstrated capability of working in an international environment.
• Demonstrated expertise in site management and monitoring (clinical or central).
• Demonstrates understanding of clinical trial management financial principles and budget management.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Must demonstrate good computer skills.
• Strong conflict resolution skills.
• Demonstrated ability to apply problem solving techniques to resolve complex issues and a risk management approach to identifying and mitigating potential threats to a clinical research project.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.

Nice to have

• Experience with risk-based monitoring.

Details

• Home-based role in Spain; location line: ESP-Remote (Barcelona).
• Moderate travel may be required, approximately 20%.