Senior Site Specialist

Welcome to PPD-Pharmaceutical Product Development! We are a leading global contract research organization that provides comprehensive drug development services to the pharmaceutical and biotechnology industries. We are currently seeking a highly motivated and experienced Senior Site Specialist to join our team.As a Senior Site Specialist, you will play a critical role in the clinical trial process by ensuring the efficient and effective conduct of studies at investigative sites. You will serve as the primary point of contact for investigative sites, collaborating with cross-functional teams to ensure timely and high-quality delivery of study activities.To be successful in this role, you must have a minimum of 3 years of experience in clinical research, with a strong understanding of ICH-GCP guidelines and regulations. You must also possess excellent communication and organizational skills, as well as the ability to work both independently and as part of a team.If you are passionate about making a difference in the pharmaceutical industry and have a strong background in clinical research, we encourage you to apply for this exciting opportunity. Join our team at PPD and contribute to the development of life-changing therapies for patients worldwide.

1. Serve as the primary point of contact for investigative sites, providing support and guidance throughout the clinical trial process.
2. Collaborate with cross-functional teams to ensure timely and high-quality delivery of study activities.
3. Conduct site feasibility assessments and initiate site selection process.
4. Train and educate investigative site staff on study protocols, procedures, and study-specific requirements.
5. Monitor site performance and compliance with study protocol, GCP, and regulatory requirements.
6. Conduct site initiation visits and provide ongoing support to ensure sites are ready to enroll patients.
7. Manage study start-up activities, including study document collection, site initiation, and regulatory submissions.
8. Develop and maintain strong relationships with investigative sites to facilitate successful study conduct.
9. Serve as a liaison between PPD and investigative sites, ensuring effective communication and issue resolution.
10. Ensure accurate and timely completion of study documentation, including site training records, essential documents, and study progress reports.
11. Assist in the development and implementation of study-specific training materials.
12. Identify and escalate potential issues or challenges at investigative sites to the project team.
13. Contribute to the development and implementation of processes and procedures to improve site performance and compliance.
14. Keep abreast of industry developments, GCP regulations, and study-specific requirements.
15. Provide guidance and mentorship to junior site specialists and other team members as needed.
16. Participate in internal and external meetings and trainings as required.
17. Act as a subject matter expert on clinical trial processes and procedures.
18. Maintain accurate and up-to-date documentation of site communication and activities.
19. Adhere to PPD's quality standards and compliance requirements.
20. May be required to travel to investigative sites for monitoring visits or other study-related activities.

According to JobzMall, the average salary range for a Senior Site Specialist in Waltham, MA, USA is $80,000-$100,000 per year. However, this can vary depending on the specific company, years of experience, and additional skills and qualifications of the individual.

PPD, Inc. is a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.