Sr. Site Management Associate

What You Will Do

Clinical Trial Execution & Site Support

• Serve as the primary point of contact for site administration and logistical needs during enrollment, maintenance, and Data Base Lock (DBL).
• Collaborate closely with PIs and study coordinators to troubleshoot technical and administrative activities and issues.
• Ensure timely site support and sustained engagement through consistent communication, proactive problem-solving, and follow-up.
• Track and monitor documentation and systems information to ensure compliance and quality standards.
• Support protocol amendment releases, mass mailings and communications, providing guidance and documentation as needed.
• Assist sites with navigation or troubleshooting of sponsor systems (e.g., IRT, EDC, eTMF, CTMS) and escalate complex issues to system Subject Matter Experts.
• Support dissemination of training materials related to protocol changes, systems updates, or new tools.
• Field questions and provide refresher guidance to sites on processes such as eCRF entries, IWRS use, SIP data entry.

Regulatory & Documentation Oversight

• Support maintenance and update of the Trial Master File (TMF) with essential enrollment and maintenance documentation to ensure inspection readiness.
• Ensure documentation of patient-related activities, deviation handling, and site correspondence aligns with GCP and internal SOPs.
• Flag inconsistencies or delays in data entry, document completion, or other quality-related indicators for follow-up.
• Support sponsor audits and inspections by preparing and providing site interaction documentation as needed.

Operational Efficiency & Collaboration

• Collaborate with monitors, CRLs, and cross-functional teams to identify unique and trending needs, operational risks, and site administrative feedback.
• Utilize internal tracking tools and systems to ensure real-time visibility into site status/compliance.
• Provide input into continuous improvement efforts by sharing insights and feedback from sites.
• Prioritize workload based on study milestones, enrollment timelines, and site needs.
• Design and implement solutions to create lasting fixes through automation, process change or quality improvements.

Required Qualifications and Experience

• Bachelor's degree in life sciences, clinical research, or a related field.
• Understanding of clinical trial processes, Good Clinical Practice (GCP), and regulatory requirements.
• Knowledge of clinical trial conduct and ICH Good Clinical Practice (GCP).
• Experience coordinating site study activities, visits, documents and participant workflows.
• Experience maintaining essential records and accurate study system information.
• Experience supporting investigators and site staff with study requirements and issue resolution.
• Experience reviewing colleagues' work and providing technical guidance on clinical research site operations.

Preferred Qualifications and Experience

• Bachelor's degree preferably in a scientific or health related field or a minimum of 5 years equivalent experience.
• Minimum of two (2) years pharmaceutical industry OR clinical research experience.
• Systems experience (Veeva, TMF) highly preferred.
• Understanding of the overall clinical development paradigm.
• Applied knowledge of customer service and/or project management processes and skills.
• Appreciation of/experience in compliance-driven environment.
• Effective communication, negotiation and problem-solving skills.
• Self-management and organizational skills.
• Aptitude to learn and engage in process automation and generative AI.
• Ability to streamline processes with technical solutions.
• Experience with innovative methodologies to enhance efficiency in clinical research.