Senior Clinical Trial Manager (Home Based, Spain)

About the role

Syneos Health is hiring a Senior Clinical Trial Manager (Sr CTM) who works remotely from Spain. The role covers the management of global or multi-country studies and requires proven vendor management experience. The position is open to Functional Service Provider partners.

Key responsibilities

• Support protocol development: Clinical Study Blueprint, protocol, amendments and administrative changes
• Manage study budgets, site contract amendments and negotiations, and oversee site and vendor payments
• Assist with site selection, feasibility questionnaires, green light letters and site contracts
• Plan and monitor study timelines, train the study team and prepare investigator meeting materials
• Review the data management plan, prepare interim and final database locks, and manage the Trial Master File
• Oversee vendors, including vendor oversight plans, contracts and work orders
• Help set up review committees, develop site closure and patient recruitment strategies, and manage risk assessments and issue logs
• Prepare the study-specific informed consent form, assist with agency responses, and keep the CTMS updated

Required profile

• Bachelor's degree or RN in a related field, or equivalent education, training and experience
• 5+ years as a CTM managing multiple countries for regional or global trials
• Proven vendor management and global study management experience
• Experience in oncology clinical trials
• Ability to lead teams, work internationally and moderate travel (about 20%)

Required skills

• Good computer skills and knowledge of clinical trial management financial principles and budget management
• Knowledge of GCP/ICH guidelines and applicable regulatory requirements
• Preferred: risk-based monitoring experience