Global Senior Project Specialist – Sponsor Dedicated

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

📋 Description

• Establish, manage, and/or finalize project files and study information, which includes regulatory documents, Trial Master File, enrollment details, adverse events/serious adverse events, site supplies, institutional review board re-approvals, and data queries.

• Participate actively in both internal and external meetings, encompassing sponsor, trusted process, functional, and investigator meetings.

• Draft and disseminate meeting minutes and action items.

• Follow up with team members to ensure closure on action items.

• Maintain prompt and effective communication among team members and site personnel.

• Keep Project Leadership and Clinical Research Associates thoroughly informed about site and study status.

• Reach out to site staff as necessary to obtain critical information.

• Offer administrative assistance to Project Leads and functional leads.

• Ensure that study documents are archived in compliance with established guidelines and policies.

• Assist in quality assurance activities, including preparation for audits and internal reviews.

• Prepare documentation and ensure resolution on actionable issues.

⛳️ Requirements

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

• Familiarity with Good Clinical Practice/ICH guidelines and other relevant regulatory requirements.

• Previous experience as a Project Specialist within a CRO/pharmaceutical company is essential.

• Excellent organizational skills.

• Experience in global trials.

• Capability to manage time effectively and work independently.

• High proficiency in all MS Office Applications.

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

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

• High level of proficiency in the English language.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition.

• Comprehensive total rewards program.

• Culture promoting total self.

• Initiatives for diversity, inclusion, and belonging.

• Extensive resources including emerging technologies, data, science, and knowledge sharing.