Clinical Trial Specialist - East Coast FSP

About the Role

The Clinical Trial Specialist will work closely with the study management team to develop, organize, and maintain tracking systems and tools across multiple programs. This will involve coordinating and leading the development of study management tools, monitoring tools, and study manuals, as well as managing documentation and tracking study progress.

Parexel is committed to improving the world's health, and this role plays a critical part in achieving that goal. By joining the team, you will have the opportunity to work on a wide range of clinical trials, from start-up to closeout, and contribute to the development of life-changing therapies.

What You Will Do

• Develop, organize, and maintain tracking systems and tools across multiple programs
• Coordinate and lead the development of study management tools, monitoring tools, and study manuals
• Manage documentation, track study progress, and collaborate with cross-functional teams
• Schedule meetings, coordinate and distribute meeting agendas, minutes, and follow-up action items
• Establish, manage, and oversee study files and shared spaces to ensure accuracy, accessibility, and compliance
• Manage documentation of study training to ensure compliance
• Manage study sample and supply accountability and develop collaborative relationships with vendor teams
• Partner with the study management team to lead or manage specific projects as appropriate
• Serve as a key point of contact for study team members, facilitating effective communication and proactive resolution of study challenges
• Conduct and oversee quality control reviews of trial-level documents ensuring compliance with study procedures and regulatory requirements

What We Are Looking For

• BS/BA degree or degree in a healthcare scientific field
• Minimum of 2+ years of experience in clinical operations within a biopharmaceutical company or 3+ years experience in a CRO environment
• Strong knowledge of drug development and clinical operations processes
• Applies working knowledge of clinical trial processes and regulatory requirements to independently support study execution
• Excellent written and verbal communication skills, effectively collaborating with study teams and site, CRO staff, and vendors
• Strong organization and interpersonal skills
• Proficiency using eTMF systems to support inspection readiness
• Strong attention to detail and consistency in document quality, compliance, and completeness
• Ability to prioritize and manage multiple tasks and competing deadlines in a fast-paced study environment
• Proficient with MS Office Suite (Excel, Word, PowerPoint) with the ability to independently develop reports and presentations

Nice to Have

• Experience with clinical invoice tracking and other budget databases for projects
• Knowledge of regulatory requirements and guidelines, including ICH and GCP
• Familiarity with clinical trial management systems and electronic data capture (EDC) systems

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work on a wide range of clinical trials and contribute to the development of life-changing therapies
• Collaborative and dynamic work environment
• Professional development and training opportunities
• Flexible working hours and remote work options
• Access to cutting-edge technology and tools
• Recognition and reward for outstanding performance

• Ensure you have a strong understanding of clinical trial processes and regulatory requirements, including ICH and GCP guidelines.
• Develop a portfolio that showcases your experience in clinical operations, including study management and documentation management.
• Be prepared to provide specific examples of your experience in managing multiple tasks and competing deadlines in a fast-paced study environment.
• Familiarize yourself with eTMF systems and clinical trial management systems to demonstrate your ability to support inspection readiness.
• Highlight your excellent written and verbal communication skills, including your ability to collaborate with cross-functional teams and vendors.
• Be prepared to discuss your experience with MS Office Suite, including Excel, Word, and PowerPoint, and your ability to develop reports and presentations.
• Research Parexel's values and mission to demonstrate your understanding of the company's commitment to improving the world's health.