Site Management Associate – Real World Evidence (US - Remote)

📋 Description

• • Syneos Health, a leading fully integrated biopharmaceutical solutions organization, is seeking a proactive and self-driven Site Management Associate (SMA) to join its expanding Real World Evidence (RWE) team. This remote US-based role offers a unique opportunity to contribute to high-impact RWE and Late Phase studies, shaping real-world insights that influence patient care and clinical decision-making.
• • As an SMA, you will serve as the primary point of contact for assigned research sites, overseeing the entire study lifecycle from initial site identification through to study closeout. Your role is crucial in ensuring the delivery of high-quality data, fostering strong site engagement, and driving efficient study execution in alignment with Syneos Health and Sponsor Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• • You will be responsible for ensuring strict compliance with all relevant regulations, including ICH-GCP, GPP, and RWE guidelines, maintaining the integrity and accuracy of the Investigator Site File (ISF) and Trial Master File (TMF). This involves meticulous record-keeping and reconciliation to ensure completeness and adherence to regulatory standards.
• • The position requires comprehensive management of all monitoring activities, encompassing both on-site and remote monitoring across all study phases. This includes overseeing site identification, qualification, and the critical start-up processes, as well as providing ongoing support to ensure sites are well-equipped and informed throughout the study duration.
• • A key aspect of the role involves supporting crucial study metrics such as subject recruitment and data quality. You will actively work with sites to resolve data queries promptly, ensuring the accuracy and reliability of the collected information. Furthermore, you will provide exceptional customer service and essential training to site staff, empowering them to conduct studies effectively and efficiently.
• • Maintaining clear, timely, and accurate documentation is paramount. This includes generating trip reports, follow-up letters, and various logs that provide a comprehensive record of site activities and progress. You will also play a vital role in ensuring sites are audit-ready and will actively support audit preparation activities, demonstrating a commitment to quality and compliance.
• • Collaboration is central to this role. You will work closely with internal Syneos Health teams, sponsor contacts, and site personnel to ensure seamless communication and coordinated efforts. Effective management of site-level timelines, communication channels, and deliverables is essential for successful project outcomes.
• • The role also involves presenting at Investigator Meetings, contributing valuable insights to team discussions, and actively participating in the continuous improvement of RWE study processes. You will have the opportunity to broaden your expertise across diverse therapeutic areas and contribute to studies that have a significant impact on patient care.
• • Syneos Health is committed to fostering a culture where employees can thrive, develop, and advance. This role offers opportunities for long-term career growth, professional development, and mentorship within a supportive and collaborative RWE team. You will be part of a group that values strong cross-functional partnerships and encourages individual contributions.
• • The ideal candidate is resourceful, organized, and solutions-oriented, possessing a natural initiative to build and maintain strong relationships with both research sites and internal teams. Flexibility in managing shifting priorities and a detail-oriented approach to high-quality documentation are key attributes for success in this dynamic environment.
• • This position is ideal for a Clinical Research Associate (CRA) looking to transition into or expand their experience within the Real World Evidence space, offering a chance to work on impactful projects that bridge the gap between clinical trials and real-world patient outcomes.