Unblinded Trial Delivery Specialist, Clinical Trial Coordinator - FSP

• Partner with Global Study Leaders to support end-to-end clinical trial delivery, ensuring alignment with study timelines, quality standards, budgets, and operational objectives.
• Coordinate cross-functional study activities.
• Oversee CROs and vendors.
• Maintain study documentation and tracking systems.
• Proactively identify, manage, and escalate risks to successful study delivery.
• Coordinate unblinded study operations as the primary point of contact for uLDLs and uCRAs.
• Support training, study documentation, and cross-functional communication.
• Oversee unblinded risk management, including protocol deviations, accidental/emergency unblinding, safety escalations, and compliance with SOPs and study procedures.
• Manage study oversight activities, including CTMS updates, IMP and ancillary supplies, third-party coordination, subject status reconciliation, and operational reporting.
• Ensure TMF completeness, accuracy, and regulatory compliance through document reviews, quality checks, and CRO oversight.
• Contribute to every stage of study delivery, from set-up to close-out.

• Graduate/Bachelor's degree in life sciences or other related fields.
• At least 1+ years of relevant work experience in a pharmaceutical environment.
• Foundational knowledge of clinical study delivery processes, including regulations and industry standards.
• Strong project management skills.
• Excellent verbal and written communication in English.
• Good knowledge of applicable clinical trial regulatory requirements.
• Ability to manage multiple competing priorities and work independently.
• Excellent collaborator coordination and communication abilities.
• Proficient in Microsoft Office tools and clinical trial management systems.

• Opportunity to contribute to life-changing therapies.
• Comprehensive training and development programs.
• A collaborative and inclusive work environment.
• Attractive compensation and comprehensive perks.
• Tailored learning pathways.
• Stretch assignments.
• Mentorship.
• Global exposure through international clinical studies across phases and therapeutic areas.
• Opportunities to strengthen global project management, financial tracking, data analysis, and risk management abilities.
• Opportunities to learn new clinical trial technologies such as AI platforms.