Site Management / CRA for Real World & Late Phase studies • • open to diverse EMEA countries • •
Syneos HealthWarszawa, Województwo mazowieckie, Polska30+ days ago
Job descriptionRequired - German language (written and spoken) Minimum 1 year of relevant CRA / Site Management experience Experience in Late Phase studies is desirable BA / BS degree in science / healthcare field or nursing degree or equivalent Proficiency in Microsoft Office Suite, email, and Clinical Trial Management and EDC systems Previous site management experience (in-house, on-site, Study Coordinator) or equivalent Excellent communication, time management, organizational, documentation, and customer service skills Knowledge of local requirements for Real World Late Phase studies and relevant regulations including GPP Strong customer focus and ability to interact professionally with clients and study sites Team-oriented with ability to work independently and seek guidance as appropriate Ability to manage multiple tasks across studies and prioritize to meet timelines; strong problem-solving and analytical skills Fluency in local language plus English; ability to travel up to 60% as required
Overview
Site Management / CRA for Real World & Late Phase studies open to diverse EMEA countries. Syneos Health is seeking candidates for the Site Management / CRA role focusing on Real World & Late Phase studies. This position may involve travel and requires collaboration with study teams across regions.
Job Responsibilities
- Perform site management activities in compliance with the Company and Sponsor SOPs and Work Instructions.
- Assure compliance with local regulations and appropriate guidance depending on assigned study design / classification (may include GPP and / or ICH-GCP).
- Conduct site management activities per agreed Scope of Work (SoW), Site Management Plan (SMP) and relevant guidelines, including site identification, qualification, start-up, and ongoing monitoring.
- Ensure selection of appropriate sites for assigned studies and manage site Start-Up activities with minimal supervision.
- Conduct remote and on-site monitoring through all study stages.
- Routinely review the Investigator Site File (ISF) for accuracy and completeness; reconcile with the Trial Master File (TMF) and ensure archiving per local guidelines.
- Document activities via letters, trip reports, logs, and other project documents within required timelines; support subject recruitment and data entry into tracking systems.
- Protect subject confidentiality; assist with data query resolution and data review to ensure timely resolution of observations and action items.
- Maintain effective communication with site staff and project team; escalate and resolve issues per SOPs with a focus on prevention.
- Maintain clinical tracking and management systems; ensure sites are trained and compliant with protocol, consent, data collection tools, and safety reporting.
- Provide guidance toward audit readiness and support preparation for audits and follow-up actions.
- Prepare for, attend, and participate in Investigator Meetings and sponsor meetings; collaborate with Sponsor affiliates, medical science liaisons, and local sponsor staff as required.
- Understand project scope, budgets, and timelines; manage site-level activities and communications to meet objectives; adapt to changing priorities with oversight as needed.
- Identify and communicate out-of-scope activities to Clinical Operations Lead.
- Attend, contribute to, and present at study and department meetings.
Qualifications
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success by translating clinical, medical affairs and commercial insights into outcomes. We aim to simplify and streamline work to help customers and employees alike.
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Management • Warszawa, Województwo mazowieckie, Polska