Global Study Start Up Lead- FSP

About the Role

Day-to-day responsibilities will involve collaborating with cross-functional teams, including clinical operations, regulatory affairs, and quality assurance. The Global Study Start Up Lead will also be responsible for tracking and analyzing study metrics, identifying risks, and implementing mitigation strategies. This role requires strong leadership and problem-solving skills, as well as the ability to work in a fast-paced and dynamic environment.

What You Will Do

• Develop and implement site start-up strategies for assigned clinical trials
• Oversee the tracking and analysis of study metrics, including risks and mitigation strategies
• Collaborate with cross-functional teams to ensure timely and efficient site activation
• Develop and maintain comprehensive and compliant documentation of site start-up materials
• Lead the preparation and approval of site regulatory packages, ensuring compliance with country-specific requirements and ICH-GCP guidelines
• Serve as a subject matter expert for essential site documents and provide training and support to teams and sites
• Represent SSU on cross-functional teams, providing updates, escalating challenges, and proposing mitigation strategies
• Act as the escalation point for CRO and internal teams to ensure timely SSU issue resolution
• Develop and maintain country intelligence data to support informed decision-making
• Support regulatory submissions as needed, including activities such as providing required site documentation and coordinating submissions to Central Institutional Review Boards (CIRBs)

What We Are Looking For

• Bachelor's degree in a related field, such as life sciences or healthcare
• At least 5 years of experience in clinical trial operations, site start-up, or a related field
• Strong knowledge of ICH/GCP guidelines, regulatory requirements, and clinical trial operations
• Excellent leadership and problem-solving skills, with the ability to work in a fast-paced and dynamic environment
• Strong communication and collaboration skills, with the ability to work with cross-functional teams
• Proficiency in Excel and other Microsoft Office applications
• Experience with clinical trial management systems and electronic data capture systems
• Strong analytical and problem-solving skills, with the ability to identify and mitigate risks

Nice to Have

• Experience working with CROs and managing outsourced studies
• Knowledge of regulatory requirements and laws in multiple countries
• Experience with process improvement initiatives and change management
• Certification in clinical trial management or a related field

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work with a leading global clinical research organization
• Collaborative and dynamic work environment
• Professional development and growth opportunities
• Flexible working arrangements, including remote work options
• Comprehensive health and wellness programs
• Generous paid time off and holiday package
• Employee recognition and reward programs

• Utilize specific examples of site start-up strategies and regulatory compliance in your application to stand out from other candidates.
• Develop a strong understanding of ICH/GCP guidelines and regulatory requirements to demonstrate expertise in clinical trial operations.
• Showcase your problem-solving skills by providing examples of risk mitigation strategies and process improvement initiatives.
• Highlight your experience working with cross-functional teams and CROs to demonstrate collaboration and leadership skills.
• Prepare to discuss your experience with clinical trial management systems and electronic data capture systems during the interview process.
• Be prepared to provide examples of your analytical and problem-solving skills, and how you have applied them in previous roles.
• Research Parexel's values and mission to understand the company culture and demonstrate your commitment to improving global health.