Study Site Specialist

Advanced Clinical; Polska; À distance; PLN 120 000 - 180 000; Plein temps

Résumé du poste

Advanced Clinical is seeking an experienced Study Site Specialist to coordinate end-to-end site start-up activities in Poland. The role requires regulatory submissions (EU CTR) via CTIS, site feasibility, and contract/budget negotiations, all within a fully remote setup.

Ideal candidates bring five+ years in site start-up or clinical operations, strong ICH-GCP knowledge, Spanish regulatory familiarity, and fluent English. A life sciences degree is required.

Qualifications

• Minimum five years in site start-up or clinical operations.
• Experience completing EU CTR and CTIS submissions.
• Fluent Spanish and strong professional English.
• Bachelor’s degree in science or life sciences.
• Knowledge of ICH-GCP and EU trial regulations.
• Experience negotiating site contracts and budgets.
• Hands-on in preparing and reviewing informed consent forms.
• Experience with CTMS (Veeva Vault) or similar systems.

Responsabilités

• Manage end-to-end study site start-up activities in Poland.
• Prepare country documentation including informed consent forms.
• Complete EU CTR submissions through CTIS.
• Coordinate site identification, feasibility and qualification activities.
• Collect, review and track regulatory documents.
• Support Ethics Committee and Regulatory Authority submissions.
• Assist in site contract and budget negotiations.
• Act as the primary point of contact for sites and study teams.
• Bring sites to Regulatory Greenlight and support maintenance.
• Maintain tracking systems and provide progress reports.
• Identify issues early and propose solutions.

Connaissances

Site start-up experience

EU CTR submissions

CTIS submissions

ICH-GCP knowledge

Spanish regulatory knowledge

English proficiency

Contract and budget negotiations

Veeva Vault / CTMS

Informed consent forms

Formation

Bachelor’s degree in science / life sciences

Outils

Veeva Vault

Description du poste

We are seeking an experienced Study Site Specialist to join a global clinical research programme. This is a permanent, fully remote position for candidates based in Poland.

Position Summary

The Study Site Specialist will manage site start-up activities in Poland, from site identification and feasibility through to regulatory approval and activation.

Main responsibilities include preparing country documentation and informed consent forms, completing EU Clinical Trials Regulation submissions through CTIS, selecting suitable sites, and granting Regulatory Greenlight.

Key Responsibilities

• Manage end-to-end study site start-up activities in Poland .
• Prepare and review country-level documentation, including informed consent forms.
• Complete EU CTR submissions through CTIS.
• Coordinate site identification, feasibility and qualification activities.
• Collect, review and track essential regulatory documents.
• Complete Ethics Committee and Regulatory Authority submissions.
• Support site contract and budget negotiations.
• Act as the primary point of contact for sites and internal study teams.
• Bring sites to Regulatory Greenlight and support ongoing site maintenance.
• Maintain accurate tracking systems and provide progress reports.
• Identify potential issues proactively and recommend appropriate solutions.
• Demonstrable experience completing EU CTR and CTIS submissions.
• Strong knowledge of Spanish regulatory and site start-up requirements.
• Hands-on experience preparing and reviewing informed consent forms.
• At least five years of relevant site start-up, contract management or clinical operations experience within a pharmaceutical company, biotechnology company or CRO.
• Good knowledge of ICH-GCP, EU clinical trial regulations and local Spanish requirements.
• Experience collecting and managing essential study documentation.
• Bachelor’s degree in science, life sciences or another relevant discipline.
• Fluent Spanish and strong professional English.
• Excellent organisational, documentation and communication skills.
• Ability to manage multiple priorities and deliver high-quality work within agreed timelines.
• Ability to work independently in a fully remote environment.
• Experience with Veeva Vault or comparable clinical trial management systems.
• Previous involvement in site contract and budget negotiations.
• Experience managing the full site start-up process through to Regulatory Greenlight.