Site Management Associate

Site Management Associate Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.   Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.   Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.   Discover what your 25,000 future colleagues already know:   Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Perform site management activities in compliance with the Company and Sponsor (if applicable) Standard Operating Procedures (SOPs) and Work Instructions (WIs). Assure compliance with local regulations and appropriate guidance depending on assigned study design / classification.  May include Good Pharmacoepidemiology Practices (GPP) and/or International Conference on Harmonization - Good Clinical Practice (ICH-GCP).  Conduct site management activities as per agreed Scope of Work (SoW), Site Management Plan (SMP) and relevant guidelines. Site identification – may contact sites to obtain interest in study participation, confirm contact details, retrieve documents for consideration, etc. Site Qualification - Ensures selection of appropriate sites for assigned studies. Site Start-Up – With minimal supervision, ability to perform activities for assigned sites working with study start-up and regulatory. Conduct of all remote and on-site monitoring activities through all study stages. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and SMP, within required timelines.  Supports subject/patient recruitment, retention and awareness strategies.  Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assigned sites data review, assisting with data query resolution and missing data follow-up (only as applicable).  Review data using data trend reports and knowledge of site practices.  Ensure the resolution of data queries within agreed timelines. Utilize available hardware and software to support effective study data collection and review. Maintain effective, accurate and timely communication with site