Job Posting Title- Senior Project Management Analyst

Location: Home-based in the U.S.

Job Overview

Provide operational support and coordination for global cSenior Project Management Analystlinical trials ensuring efficient trial execution from planning through close-out. Responsible for managing trial-related documentation systems communication and logistics in compliance with SOPs ICH-GCP and regulatory requirements while meeting quality and timeline objectives.

Essential Functions

• 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.
• Collaborate with global and regional stakeholders vendors and trial teams to ensure seamless trial conduct and communication.
• Manage and maintain clinical trial systems databases and tracking tools ensuring data accuracy.
• 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.
• Coordinate documentation workflows regulatory submissions and communication with authorities and regional teams.
• 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.

Qualifications

• University degree qualified and/or comparable professional education with at least 3 years experience in clinical trial operations or project coordination.
• Exceptional communication and stakeholder management skills.
• 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.
• Detail-oriented with strong commitment to quality and compliance.
• Proficiency in MS Office and clinical trial systems/tools.
• Fluent in written and spoken English.

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