Global Senior CTM — Remote in Spain (Oncology)

Syneos Health; España; Remote; EUR 90,000 - 130,000; Full time

Job summary

Syneos Health is seeking a Global Senior CTM to lead clinical trial management from a home-based position in Spain. The role requires managing global multi-country studies, vendor oversight, budget handling, and study timelines, with moderate travel.

Applicants should have 5+ years as CTM, strong vendor management, and experience in oncology trials, regulatory knowledge, and CTMS proficiency. Remote work in Spain with potential site interactions and WB responsibilities.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience
• 5+ years 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)
• Preferred experience with risk-based monitoring
• 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 apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
• Moderate travel may be required, approximately 20%

Responsibilities

• Experience as CTM in the management of global/multiple-countries studies and different types of vendors is required
• Protocol Development: Support the development and review of the Clinical Study Blueprint (CSB) and Protocol, and all Amendments and/or Administrative Changes
• Budget: Manage the execution of the CDAs; support Project Managers in the creation of overall study budget; support site contract amendments and negotiation; manage invoices
• Country and Site Feasibility and Selection: assist in development of Investigator Site Selection Plan; attend country and site selection Jams; Assist with creation of Feasibility Questionnaire; assist with Site Selection and Green Light Letters, if applicable
• Site/Country Contracts and Budgets: stay informed of progress with CDAs, CSA and site budgets; support sites for contract amendments; assist with negotiation for site contracts
• Financial/Payment Management: oversight of site payments and vendor payments, if applicable
• Study Budget Financial Reconciliation: draft and facilitate the Clinical Study Budget review
• Clinical Study Timelines: Support the planning for the clinical study timelines, finalization and update of clinical study timelines; and manage the study team to meet all timelines
• Study Team Training: Assist/support in the creation/finalization of Study Specific Training; Facilitate training sessions; Assign training as appropriate; assist with creation/finalization of Study Monitor Training materials
• Site Training: Assist Project manager in planning for the Investigator Meeting; creation of and collection of slides from all functional areas to create the final master deck for the IM; presenting at the IM, filing documentation of training
• Data Management and Closeout: Review updates to Data Management Plan; Interim/Final Db Lock Preparation; Interim/Final Database Lock Preparation
• Plans: Site Selection Plan, Study-Specific Issue Management Plan , Vendor Oversight Plan, TMF Artifact Map and Plan
• Clinical Supplies: Assess and review of materials by external vendors
• Investigational Product: responsible for overall study reconciliation of IP
• Vendor Oversight: Assist with selection of vendors; Create and manage Vendor Oversight Plan for each vendor; review vendor contracts, work orders and Change Orders; day to day oversight of vendors
• Establish Review Committees: creating charter, assisting with member selection, contracting as needed, updating Annual Plan
• Site Closure Strategy: develop site closure plan
• Patient Recruitment Strategy: assist Project Managers in development of patient recruitment strategy and plan; develop recruitment materials; drive strategies for needing new sites
• Trial Master File: support customization of study/country/site specific docs; upload documents, reference Master File Index; oversight of TMF health; TMF reconciliation; TMF archival; quarterly TMF review
• Risk Management: initial Risk Assessment and Mitigation Plan (RAMP) and maintain throughout study; responsible for Issue Management throughout the study; quarterly Issues review
• ICF and Study Specific Language: responsible for building the study specific ICF incorporating appropriate study specific language and safety language
• CTA submissions and approvals: responsible for assisting with agency responses
• Meetings: Clinical Study Team meetings, conducting vendor meetings; responsible for agendas and meeting minutes
• Clinical Trial Management System: Keep CTMS updated at study level

Skills

Leadership

International collaboration

Problem solving

Communication

Vendor oversight

Education

Bachelor's degree or RN in a related field

Tools

CTMS

Job description

Syneos Health is seeking a Global Senior CTM to lead clinical trial management from a home-based position in Spain. The role requires managing global multi-country studies, vendor oversight, budget handling, and study timelines, with moderate travel.

Applicants should have 5+ years as CTM, strong vendor management, and experience in oncology trials, regulatory knowledge, and CTMS proficiency. Remote work in Spain with potential site interactions and WB responsibilities.