We've got a great long term contract role for a German, Polish, Russian or Ukrainian speaking Site Manager with an excellent command of English to be based at our client's site in West London.

As a key member of the project team and will provide in-house operational support to study teams and in-house site management of clinical research sites, ensuring country and site targets are achieved in compliance with ICH/GCP and SOPs.

Key Responsibilities:

• Performs and coordinate all aspects of the clinical site management
• First point of contact for investigators/site personnel for assigned sites
• Responsible for review and collation of site trial related documentation (site contracts, consent documents, letters of agreement, confidentiality agreements)
• Track patient recruitment and report on site issues/strategies to increase patient accrual into the trial (e.g. investigator and research nurse meetings, update newsletters, advertising, letters to GPs)
• Oversee tracking of completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion.
• Conducts remote monitoring and site visits - assessing protocol and regulatory compliance, and reporting conduct using applicable documentation
• Escalates and logs site level issues to CRA/PM as appropriate
• Ensure site staff are trained in TRI and protocol specific procedures and are ICH-GCP compliant.
• Day to day operational support to Lead Ops, CPMs, CRAs for defined tasks during study
• Collects, co-ordinates and maintains essential documents for the Investigator Site Files (ISFs) and the Trial Master File (TMF)
• Supports logistics of investigator and monitor meetings organisation including the development of presentation materials under direction of PM/CRA
• Development and distribution of newsletters for investigators and monitors
• Development and maintenance of study specific documents and tracking tools under direction of PM/CRA
• Supports CRA and project team with Health Authority/ IRB submissions and ensures approvals are tracked
• Awareness of and compliance to laws and regulations applicable to projects
• Demonstrate high ethical behaviour at all times, whether dealing with colleagues, vendors, site staff or physicians.

• Reports legal, compliance and ethical violations in a timely manner.

Desired skills and experience

• Life science or other relevant degree
• Good organizational skills
• Excellent interpersonal skills
• Hard worker, motivated and eager to learn
• Flexible and effective communication and negotiation skills
• Ideally an understanding of cardiovascular disease and treatment
• Knowledge of observational clinical trials

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