Study Start-Up Lead

Welcome to IQVIA – a leading global provider of advanced analytics, technology solutions, and contract research services to the life sciences industry. As a Study Start-Up Lead with our organization, you will play a crucial role in the successful initiation of clinical trials, ensuring timely and efficient study start-up processes. We are seeking a highly organized and detail-oriented individual with experience in clinical research and a passion for driving excellence in study start-up. If you are a proactive leader with excellent communication skills and a strong understanding of regulatory requirements, we invite you to join our dynamic team and make a meaningful impact in the field of healthcare.

1. Lead and manage the study start-up process for clinical trials, ensuring timely and efficient initiation of trials.
2. Develop and maintain study start-up plans, timelines, and budgets.
3. Collaborate with cross-functional teams to ensure alignment and coordination of study start-up activities.
4. Ensure compliance with applicable regulatory requirements, including ICH-GCP and local regulations.
5. Review and negotiate study contracts and budgets with investigative sites.
6. Identify potential risks and issues related to study start-up and develop mitigation plans.
7. Communicate regularly with internal and external stakeholders to provide updates on study start-up progress.
8. Train and mentor study start-up team members, providing guidance and support as needed.
9. Monitor and track study start-up metrics and identify areas for improvement.
10. Maintain accurate and complete study start-up documentation.
11. Participate in study start-up meetings and provide input and recommendations.
12. Keep abreast of industry trends and changes in regulatory requirements related to study start-up processes.
13. Foster a culture of quality and continuous improvement within the study start-up team.
14. Collaborate with other departments to improve and streamline study start-up processes.
15. Act as a point of contact for study start-up-related inquiries and provide timely and accurate responses.

According to JobzMall, the average salary range for a Study Start-Up Lead in Durham, NC, USA is $63,000 to $103,000 per year. However, this can vary depending on the specific company, experience level, and other factors. Some companies may offer higher salaries or additional benefits such as bonuses or stock options. It is important to research and compare salaries at specific companies to get a more accurate understanding of the salary range for this position.

IQVIA, formerly Quintiles and IMS Health, Inc., is an American multinational company serving the combined industries of health information technology and clinical research.