Senior Clinical Project Support Specialist – Sponsor Dedicated

Das ist der Job

Manage and maintain clinical trial systems, databases, and tracking tools ensuring data accuracy.

Darum lohnt es sich

Collaborate with global and regional stakeholders, vendors, and trial teams to ensure seamless trial conduct and communication. Coordinate documentation workflows, regulatory submissions, and communication with authorities and regional teams.

Strong knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Excellent organizational and problem‑solving skills with ability to work independently, prioritize tasks, and manage projects in a complex international environment.

Responsibilities Plan, coordinate, and execute clinical trial activities across regions in compliance with ICH‑GCP, ensuring timely and high‑quality delivery. Maintain and oversee trial documentation (e.g., ISF, TMF, submissions), ensuring completeness, accuracy, timeliness and audit readiness.

Prepare and distribute project plans, status updates, reports, and presentation materials. Monitor trial progress, budgets, and system data, identifying risks and implementing corrective actions as needed. Support reporting, trial close‑out activities, and preparation of key deliverables (e.g., CTR appendices).

Coordinate logistics for trial meetings, materials, and supplies. Contribute to quality oversight, inspection readiness, and best practices in clinical trial conduct. Act as a key point of contact for trial‑related systems, documentation, and operational queries. Requirements University degree qualified and/or comparable professional education.

At least 5 years’ experience in clinical trial operations or project coordination including solid background in vendor management. Experience in global clinical trials. Fluent in written and spoken English. Exceptional communication and stakeholder management skills. Detail‑oriented with strong commitment to quality and compliance.

Proficiency in MS Office and clinical trial systems/tools. Knowledge of OMP / Veeva system will be highly advantageous. #J-18808-Ljbffr