Global Sr CTM - Home Based in SPAIN. FSP. Vendor experience required

Overview

Global Senior Clinical Trial Manager (CTM) home-based in Spain, working on a Functional Service Provider (FSP) basis, managing global or multi-country studies and vendors.

What you'll do

• Support development and review of the Clinical Study Blueprint (CSB), Protocol, and all amendments and administrative changes.
• Manage execution of CDAs, support Project Managers in creating overall study budget with the contract/budget analyst, support site contract amendments and negotiation, and manage invoices.
• Assist in development of the Investigator Site Selection Plan, attend country and site selection Jams, assist with creation of the Feasibility Questionnaire, and assist with 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 negotiation of site contracts.
• Oversee site payments and vendor payments, if applicable.
• Draft and facilitate the Clinical Study Budget review and support overall study budget financial reconciliation.
• Support 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, and assist with Study Monitor Training materials.
• Assist Project Manager in planning the Investigator Meeting, create the master deck by collecting slides from all functional areas, present at the IM, and file training documentation.
• Review updates to the Data Management Plan and drive study database lock completeness for interim and final database lock preparation.
• Develop and maintain 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.).
• Be responsible for overall study reconciliation of investigational product (IP).
• Assist with vendor selection, create and manage a Vendor Oversight Plan for each vendor, review vendor contracts, work orders and change orders, and provide day-to-day vendor oversight.
• Create review committee charters, assist with member selection, contract 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 and site-specific documents, upload documents referencing the Master File Index, oversee TMF health, perform TMF reconciliation, archival and quarterly TMF review.
• Prepare the initial Risk Assessment and Mitigation Plan (RAMP), maintain it throughout the study, be responsible for 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, and be responsible for agendas and meeting minutes.
• Keep the Clinical Trial Management System (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.
• Experience as CTM in the management of global/multiple-country studies and different types of vendors.
• 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).
• Understanding of clinical trial management financial principles and budget management.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Good computer skills.
• Strong conflict resolution skills.
• Demonstrated ability to apply problem-solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
• Critical thinking to determine the cause and appropriate solution in the identification of issues.

Nice to have

• Experience with risk-based monitoring.

Details

• Location: Spain, home-based (ESP-Remote, Barcelona).
• Moderate travel may be required, approximately 20%.