Senior Project Specialist – Sponsor Dedicated

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

📋 Description

• Establish, maintain, and/or finalize project files and study data (including regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) across various databases and systems.

• Attend, engage in, prepare, and disseminate meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings).

• Follow up with team members to ensure action items are resolved.

• Maintain timely and effective communication with team members and site personnel.

• Keep Project Leadership and Clinical Research Associates (CRAs) fully informed about site and study progress.

• May reach out to site personnel as necessary for essential information.

• Provide administrative assistance to Project Leads and functional leaders.

• Ensure all study documents are archived in accordance with the relevant guidelines and policies.

• Support quality assurance activities, including audit preparation and internal reviews, by preparing documentation and following through to resolve actionable issues.

⛳️ Requirements

• Associate's Degree (or equivalent) in life sciences, Medicine, Pharmacy, Nursing, or a related field, or a comparable combination of education and experience.

• Understanding of Good Clinical Practice/ICH guidelines and other relevant regulatory requirements.

• Excellent organizational abilities.

• Capability to manage time effectively and work autonomously.

• High proficiency in all MS Office applications.

• Strong communication, presentation, and interpersonal skills, both written and verbal, with the ability to inform, influence, and persuade.

• Willingness to travel if necessary (approximately 5%) is preferred.

• High level of proficiency in the English language.

🏝️ Benefits

• We are dedicated to developing our employees through career advancement opportunities, supportive and engaged management, technical and therapeutic training, peer recognition, and a comprehensive rewards program.

• We are committed to fostering an inclusive culture where you can genuinely be yourself. Central to this is our mission – Driven to Deliver – which embodies the passion of our colleagues to show up each day and create solutions that can significantly impact someone’s life.