Site Activation Manager II

Syneos Health, Inc.

Job Overview

Location

GRC-Remote

Job Type

Full-time

Full Job Description

📋 Description

• Lead and manage Site Start-Up (SSU) deliverables across assigned countries, regions, or globally, ensuring timely, budget-compliant, and regulatory-compliant activation of clinical trial sites.
• Oversee the full lifecycle of site activation activities, from site selection and recommendation through regulatory submissions, contract execution, budget negotiation, essential document collection, and ongoing maintenance.
• Develop and maintain integrated SSU timelines, proactively identifying and mitigating risks to project timelines, and reporting weekly progress to project teams, Project Managers, and Sponsor stakeholders.
• Collaborate cross-functionally with Business Development, Alliance Management, Contracts, Project Management, Clinical, Data Management, and Medical Writing teams to align on study requirements and deliverables.
• Prepare and submit core clinical trial application dossiers and amendment documents to competent authorities and ethics committees, ensuring compliance with ICH GCP and local regulations.
• Conduct Regulatory Impact Assessments on amendment submissions, identify potential risks, and communicate mitigation strategies to Sponsor and Project teams.
• Oversee the negotiation, execution, and amendment of Clinical Trial Agreements (CTAs) and investigator budgets, ensuring alignment with project financial goals and sponsor expectations.
• Manage the collection, quality review, and submission of country-specific regulatory applications and ensure all documentation is accurately filed in the Trial Master File (TMF) per SOP and sponsor requirements.
• Review and manage SSU budgets in collaboration with functional leads, Project Managers, and the SSU Business Unit Controller, taking corrective actions to maintain profitability and gross margin targets.
• Identify and resolve complex operational and regulatory issues impacting site activation, applying sound business judgment to ensure successful patient enrollment and study progress.
• Prepare and present SSU strategy, status updates, and risk assessments during client meetings, translating outcomes into actionable plans for internal teams.
• Contribute to the development and refinement of master Subject Information Sheets (SIS) and Informed Consent Forms (ICF) in partnership with Project Managers and the Medical Department.
• Ensure adherence to Standard Operating Procedures (SOPs) and sponsor-scoped processes, maintaining quality standards across all SSU activities.
• Track and manage out-of-scope work requests, escalating to Project Managers and SSU Managers for proper backlog assignment and resource allocation.
• Support departmental change initiatives and contribute to continuous improvement of SSU processes and tools.
• Perform other duties as assigned, with minimal travel required (up to 25%).

🎯 Requirements

• Bachelor’s Degree; Higher Degree preferred
• Excellent understanding of clinical trial processes across Phases II-IV and ICH GCP
• Proven project management experience in a fast-paced clinical research environment
• Strong knowledge of clinical trial start-up processes, including regulatory submissions and site activation
• Excellent communication, presentation, and interpersonal skills
• Demonstrated ability to manage multiple projects simultaneously with high organizational rigor

🏖️ Benefits

• Career development and progression opportunities
• Technical and therapeutic area training programs
• Supportive and engaged line management
• Peer recognition and total rewards program
• Inclusive culture focused on authenticity and purpose-driven work
• Opportunity to contribute to the development of novel FDA-approved drugs and EMA-authorized products

Skills & Technologies

GCP

Remote

Degree Required

Ready to Apply?

Apply Externally

You will be redirected to an external site to apply.

AI Job Fit Analysis

Pro

See exactly how your profile matches this role — strengths, skill gaps, and what to do about them.

Syneos Health, Inc.

Visit Website

About Syneos Health, Inc.

Syneos Health is a global biopharmaceutical services organization providing clinical and commercial solutions. It integrates clinical development, outsourced commercialization, consulting, and communications services to accelerate the delivery of therapies to market. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of product development and commercialization, operating in North America, Europe, and Asia-Pacific.

View Company Profile

Get more remote jobs like this

Subscribe to the weekly newsletter for similar remote roles and curated hiring updates.

Weekly remote jobs and featured talent.

No spam. Only curated remote roles and product updates. You can unsubscribe anytime.