Trial Delivery Specialist/ Clinical Trial Coordination, FSP

About the Role

In this role, you will be part of a global team that spans laboratory, digital, and decentralized clinical trial services, working on clinical trials conducted in over 100 countries. Your expertise in clinical trial management, data analysis, and project planning will be essential in ensuring the integrity of trial coordination activities, managing risks, and driving study delivery to meet quality, timeline, and budget objectives.

What You Will Do

• Work as a partner with the global study leader to monitor study conduct and progress, identifying, resolving, and escalating risks that impact delivery of the study
• Review key clinical documents, including the protocol and informed consent forms, and support the development of study plans
• Coordinate all study-related activities and manage study cross-functional team's communication, including meetings preparation and scheduling
• Facilitate and monitor all communication interactions with internal and external study team members, including regulatory, LOC, CROs, and third-party vendor partners
• Support country oversight activities, acting as a primary point of contact, tracking recruitment progress, data completeness and compliance, local budgets, protocol deviations, and import license status
• Oversee delivery of clinical supplies, investigational products, and all study materials provided by external service providers
• Alert the study teams to issues or risks to continuity of supplies and recommend proposed actions
• Ensure data oversight to ensure the study is inspection-ready, overseeing eTMF completeness, setup, periodic reviews, and following up on missing documents
• Manage change orders, expenses, and ensuring consistency between systems and agreements, escalating issues to the study stakeholders

What We Are Looking For

• Graduate/Bachelor's degree in life sciences or other related fields
• At least 1+ years of relevant work experience in clinical trial management or a related field
• Strong expertise in Excel and data analysis
• Experience with data oversight, vendor management, and project planning
• Excellent communication and interpersonal skills, with the ability to work effectively in a remote environment
• Strong problem-solving skills, with the ability to identify, resolve, and escalate risks
• Ability to work in a fast-paced environment, prioritizing multiple tasks and meeting deadlines

Nice to Have

• Experience with eTMF and clinical trial management systems
• Knowledge of regulatory requirements and guidelines for clinical trials
• Certification in clinical trial management or a related field

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work on high-impact projects that make a meaningful difference in the lives of patients and communities
• Collaborative and dynamic work environment with a global team
• Professional development opportunities, including training and certification programs
• Flexible working hours and remote work arrangements
• Access to cutting-edge technology and tools
• Recognition and reward programs for outstanding performance

• Ensure your resume and cover letter are tailored to the role, highlighting your expertise in clinical trial management, data analysis, and project planning
• Showcase your experience with data oversight, vendor management, and eTMF, and be prepared to provide specific examples of your accomplishments in these areas
• Develop a strong understanding of the company's mission and values, and be prepared to discuss how your skills and experience align with these
• Practice your communication and interpersonal skills, as these are essential for success in this role
• Research the company's culture and work environment, and be prepared to ask informed questions during the interview process
• Be prepared to discuss your experience with remote work, and how you stay motivated and productive in a virtual environment