Global Senior CTM — Remote (Spain) for Oncology Trials

Syneos Health Careers; Madrid; À distance; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Syneos Health is seeking a Global Senior Clinical Trial Manager for a home-based role in Spain. You will manage global/multi-country studies and oversee vendor relationships, ensuring milestones and timelines are met.

You will lead protocol development, budgets, country/site feasibility, site contracts, payments, data management, and TMF activities, coordinating with cross-functional teams and external partners to deliver high-quality results.

Qualifications

• 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.
• Demonstrates knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Moderate travel may be required, approximately 20%

Responsabilités

• 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 meetings; assist with Feasibility Questionnaire; assist with Site Selection and Green Light Letters
• 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
• Study Budget Financial Reconciliation: draft and facilitate the Clinical Study Budget review
• Clinical Study Timelines: Support planning for timelines, finalization and update of timelines; manage the study team to meet timelines
• Study Team Training: Assist/support in creation/finalization of Study Specific Training; Facilitate training sessions; assign training; assist with creation of Training materials
• Data Management and Closeout: Review updates to Data Management Plan; Interim/Final DB Lock Preparation; TMF-related activities

Connaissances

Vendor management

Global study management

Oncology clinical trials

Budget management

CTMS experience

Study plans & documentation

Risk management

Cross-country coordination

Formation

Bachelor's degree or RN in a related field

Outils

CTMS

Description du poste

Syneos Health is seeking a Global Senior Clinical Trial Manager for a home-based role in Spain. You will manage global/multi-country studies and oversee vendor relationships, ensuring milestones and timelines are met.

You will lead protocol development, budgets, country/site feasibility, site contracts, payments, data management, and TMF activities, coordinating with cross-functional teams and external partners to deliver high-quality results.