Site Activation Manager

About the role

Syneos Health is looking for a Site Activation Manager to join its team in Switzerland, working on single-sponsor partnerships. The role collaborates with major functional areas such as Business Development, Alliance Management, Contracts and Proposals Development, SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing.

Key responsibilities

• Identify and evaluate issues related to site start-up, regulatory pathways, patient enrollment and complex data interpretation, and ensure solutions are implemented.
• Ensure project deliverables meet internal and customer expectations, provide accurate projections, reports and updates, and manage risks.
• Develop and maintain customer relationships and ensure project targets, service quality and policies are met.
• Oversee site start-up deliverables, including regulatory activities, study maintenance and amendment submissions, and oversight of amended clinical trial agreements and investigator budgets.
• Manage integrated timelines, report weekly progress and present the site start-up strategy and status at client meetings.
• Review the site start-up budget with functional leads, the project manager and the SSU Business Unit Controller, and take corrective action to protect profitability.
• Use professional tools for planning scope, timeline and resources, and track out-of-scope work until it is added to the backlog.
• Prepare core submission documents and clinical trial application dossiers for amendments, perform regulatory impact assessments and oversee reviews.
• Assist in updating the master Subject Information Sheet and Informed Consent Form, and oversee country-specific applications.
• Submit documents to the Trial Master File and contribute to change initiatives within the SSU department.

Required profile

• Ability to work remotely, with minimal travel (up to 25%).
• Equivalent experience, skills and/or education will be considered.