CST Project Manager (eCOA Manager) - Remote EMEA

About the role

Syneos Health is hiring a CST Project Manager (eCOA Manager) working remotely for several EMEA countries. The role provides customer-focused management of Clinical Surveillance & Training (CST) scoped services to support scientific integrity and data quality in clinical trials, liaising with customers, vendors and investigative sites from project start-up to final deliverables. With proficiency, the position may move to the CST Sr. Project Manager level.

Key responsibilities

• Act as a representative of the CST team on studies and programs, interacting with vendors, license holders, KOLs and sponsors, and serve as project lead in CST stand-alone projects and functional lead in multi-protocol projects.
• Manage CST deliverables for vendors, scale license holders and KOLs, including license procurement, scale translation requirements and paper scale worksheets.
• Create and maintain CST documentation and templates, including the CST Study Training and Engagement Portal (STEP).
• Develop and maintain the study-specific CST plan according to SOPs and WIs, and contribute to functional project plans.
• Provide regular status updates to internal and sponsor teams, including delivery risks, and act as central point of contact for CST issues.
• Create and maintain CST metric reports for clients, attend Trusted Process meetings, and keep project documentation complete and accurate in the TMF.
• Identify risks and develop mitigation plans, and take part in audits and inspections.
• Manage CST scope, including out-of-scope activities, overburn, revenue recognition, invoicing and KOL contracts, and plan and request CST resources.
• Train and mentor internal team members.

Required profile

• Bachelor's degree (or equivalent) in Life Sciences, Medicine, Pharmacy, Nursing or a related field preferred.
• Prior experience in study coordination, CRO, pharma, biotech or rater training preferred.
• High-level English competency and ability to travel up to 25%.

Required skills

• Proficiency with MS Office applications.
• Strong knowledge of GCP and ICH guidelines and other regulatory requirements.
• Excellent communication, presentation and organisational skills, able to multitask under tight deadlines.