On-site Monitor

Overview

Site Manager / CRA - Late Phase UK role at Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

• 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.
• Ensure 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 review the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconcile contents of the ISF with the Trial Master File (TMF). Ensure the investigator/physician site is aware of archiving essential documents in accordance with local guidelines and regulations.
• Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and SMP, within required timelines. Support subject/patient recruitment, retention and awareness strategies. Enter data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
• Demonstrate diligence in protecting the confidentiality of each subject/patient.
• Assigned sites data review, assisting with data query resolution and missing data follow-up (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 staff and project team, and ensure appropriate issue escalation and resolution as per SOPs with a focus on issue prevention.
• Maintain clinical tracking and management systems.
• Ensure all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements/data collection tools and safety reporting.
• Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
• Prepare for, attend and participate in Investigator Meetings and/or sponsor face-to-face meetings.
• As required, collaborate and build relationships with Sponsor affiliates, medical science liaisons, and local country sponsor staff.
• For assigned activities, understand project scope, budgets, and timelines; manage site-level activities/communication to ensure project objectives, deliverables and timelines are met. Be able to adapt quickly under supervision to changing priorities.
• Identify and communicate out of…