Senior Site Specialist

This is a fully remote position, open to applicants in Poland, +1 more country.

📋 Description

• Oversee advanced activities at investigator sites throughout the Benelux region, which includes the collection, review, and maintenance of essential documents for assigned sites and studies.

• Assist with local study initiation activities, such as CTIS submissions, gathering regulatory documents, and coordinating country-specific requirements.

• Serve as the primary point of contact for site staff regarding operational inquiries, documentation needs, regulatory processes, and study protocols.

• Ensure timely and accurate updates of site statuses, regulatory information, and study data in clinical trial management systems and trackers.

• Organize site visits, meetings, and communications with investigator sites in collaboration with Clinical Research Associates (CRAs), start-up teams, and other project stakeholders.

• Identify opportunities to enhance site workflows, improve site engagement, and contribute to initiatives aimed at process improvement.

• Offer guidance and mentorship to junior team members regarding site support processes, regulatory requirements, and industry best practices.

⛳️ Requirements

• A Bachelor's degree in Life Sciences, Healthcare, Business, or a related field, or equivalent experience in clinical research.

• Significant experience in site support, clinical trial administration, study start-up, or comparable roles within a CRO, pharmaceutical company, or healthcare setting.

• Proficient understanding of clinical trial processes, ICH-GCP guidelines, and requirements for site documentation.

• Experience in supporting regulatory activities, including CTIS submissions and country-specific start-up requirements, is highly preferred.

• Strong organizational skills and meticulous attention to detail, with the capability to manage multiple sites, studies, and competing priorities.

• Excellent communication and interpersonal skills, coupled with a customer-centric approach to investigator site support.

• Ability to work both independently and collaboratively, with experience in supporting or mentoring junior colleagues.

• Proficiency in Dutch or French and English is essential.

• Legal authorization to work in the country where the position is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.