For our client from the clinical research / life sciences industry, we are currently looking for a part-time, remote-first Senior Site Manager. The role is heavily focused on study start-up and site contract/budget negotiations with monitoring activities performed as needed.

Tasks:

• Lead Site Start-Up (SSU) activities for RWE/NIS projects in Poland: site identification support and start-up planning aligned with project timelines.
• Prepare and manage ethics/regulatory submissions: initial and maintenance submissions, ICF country adaptation, collection/review of essential regulatory documents, and audit-ready filing..
• Own site contract and budget negotiations with PIs and hospitals, including contract execution, amendments, and related agreements.
• Maintain day-to-day site management and communication: document all site interactions, follow up on action items, escalate risks/issues and keep internal trackers/systems up to date.
• As needed, perform remote and occasional on-site initiation/monitoring/close-out activities within the contracted scope of work, in line with SOPs, GCP and local regulations.

Requirements:

• Strong, proven track record in clinical study start-up in Poland, with hands-on responsibility for site contract and budget negotiations (must-have).
• Monitoring experience (remote and/or on-site) and solid understanding of the clinical research process, ICH-GCP and local regulatory requirements.
• Ability to work effectively within a structured CRO environment: independent, responsive, reliable, and able to follow defined processes and study team instructions.
• Fluent Polish and advanced English (written and spoken) for stakeholder communication and negotiation.
• Systems/tools: experience with CTMS and TMF platforms plus strong MS Office skills (Word/Excel/Outlook).
• Nice to have: law degree / legal background.

Offer:

• Part-time, remote-first assignment (with occasional in-country travel depending on site/project needs).
• Work on newly starting projects with clear ownership of SSU deliverables and contract/budget negotiations.
• Collaboration with international study teams .
• Fast onboarding possible for candidates with previous experience within the same environment, including existing system access and completed mandatory trainings.
• Interview process: 1 stage (online, MS Teams).
• Contract of employment via Grafton Recruitment.