Senior Trial Vendor Manager - FSP

This is a fully remote position, open to applicants in Poland.

📋 Description

• Take responsibility for all operational trial deliverables related to vendors, ensuring adherence to timelines, budget constraints, operational procedures, quality/compliance, and performance benchmarks.

• Partner with the Vendor Study Manager (VSM) for category-specific tasks.

• Oversee all activities for which there is no assigned VSM and manage all service deliveries post Study Start-up when the VSM is no longer involved in the study.

⛳️ Requirements

• A minimum of 7 years of professional experience with a strong understanding of clinical operation processes and vendor management, particularly in Phase I/IIa (Early Phase).

• Experience working in a global setting or as part of a global study team, adept at managing relationships with key stakeholders.

• Direct experience with vendor management and oversight, serving as the primary contact for vendor management activities throughout the lifecycle of global clinical trials.

• Proven experience with direct vendor management and oversight, including but not limited to IRT/eCOA/Central Labs/Cardiac/ECG/PR&R at a global level.

• Ability to manage vendor performance, quality, compliance, timelines, and budget effectively.

• Experience in vendor-related risk management, issue escalation, and process improvement.

• Proven collaboration skills with cross-functional teams (e.g., Study Leadership, Data Management, Medical, procurement, etc.).

• Exceptional communication, negotiation, and stakeholder management abilities.

• Familiarity with GxP/ICH guidelines and operational processes within clinical studies.

• Experience in study start-up activities, including translating protocol/concept sheets into vendor specifications, gathering documents for submissions, UAT (eCOA, IRT, etc.), site readiness, and systems/tools.

• Capability to manage multiple vendors simultaneously, understanding how to navigate complexity and competing priorities.

• Involvement in UAT, identifying issues from both patient and trial operational perspectives.

• Follow-up with vendors to resolve issues prior to the go-live date and manage fixes and any necessary re-testing.

• Experience with close-out activities and reconciliation; oversight of invoice and vendor budget reconciliation is preferred.

• Audit experience is preferred.

• Experience with sponsor/CRO/vendor transition studies is preferred.

• Familiarity with protocol amendment processes.

🏝️ Benefits

• Health insurance

• Flexible work arrangements