Site Start-Up Project Delivery Lead
Location: Syneos Health, Global
About Syneos Health
Syneos Health is a leading global biopharmaceutical solutions organization committed to accelerating customer success. By leveraging clinical, medical, and commercial insights, we deliver real-world outcomes and help customers navigate modern market realities. Our mission focuses on simplifying and streamlining clinical development, putting both the customer and patient at the center of everything we do. With over 29,000 employees across 110 countries, we are passionate about creating meaningful change in the lives of patients.
"Work Here Matters Everywhere."
Why Syneos Health?
We are dedicated to developing our people through career growth, training, mentorship, and peer recognition. Our Total Self culture fosters an environment where employees can bring their authentic selves to work. Syneos Health thrives on diversity and inclusion, uniting people from different backgrounds to build a stronger, more innovative workforce.
Key Responsibilities
Project Collaboration & Stakeholder Management:
Work with functional area leads (SSU Country Managers, Project Management, Clinical Management) to identify key issues related to site start-up and regulatory pathways, ensuring the successful enrollment of patients.
Maintain strong customer relationships, ensuring project deliverables meet client expectations and timelines. Act as a liaison between business leads, project management, and clinical teams to achieve project goals.
Participate in business development activities, including client presentations and proposal development.
Site Start-Up Oversight:
Oversee all aspects of site start-up activities, including regulatory submissions, investigator contract negotiations, and essential document collection leading to site activation.
Manage integrated site start-up timelines, ensuring weekly progress updates are provided and any risks or gaps in timing are addressed proactively.
Collaborate with internal teams to ensure clinical trial agreements (CTAs) and investigator budgets are negotiated and executed on time.
Regulatory & Compliance Management:
Prepare and submit core submission documents and clinical trial application dossiers.
Ensure the timely follow-up of Ethics Committee/Competent Authority queries and objections, escalating issues as necessary.
Ensure compliance with Standard Operating Procedures (SOPs), sponsor processes, and regulatory requirements for all SSU activities.
Budget & Resource Management:
Monitor SSU budgets, tracking project milestones and ensuring profitability. Take corrective actions when necessary to keep projects aligned with financial goals.
Use planning and project management tools to ensure resource allocation is optimized, and out-of-scope work is managed appropriately.
Quality Assurance & Process Improvement:
Identify best practices and contribute to ongoing process improvements within the SSU department.
Support the development and update of training materials and SOPs/WIs for the SSU team.
Maintain a strong focus on quality, ensuring all activities are executed according to the highest standards.
Qualifications
Education & Experience:
Bachelor’s Degree (Higher Degree preferred).
Minimum of 6 years’ experience in the CRO industry, or 3 years in SSU or clinical trial environments.
Proven experience leading at least 5 studies, with at least 2 studies covering more than 10 countries across multiple regions.
Skills & Competencies:
In-depth knowledge of clinical trial processes (Phases II-IV) and ICH GCP guidelines.
Strong understanding of clinical trial start-up processes, project management, and vendor management.
Excellent communication, presentation, and interpersonal skills.
Strong negotiating and problem-solving abilities.
Ability to manage multiple projects in a fast-paced environment while maintaining quality and meeting deadlines.
Why Work with Us?
Career Development: Grow and advance your career in a dynamic, global organization.
Inclusive Culture: Thrive in a diverse and supportive environment that celebrates your unique contributions.
Impactful Work: Play a key role in delivering therapies that have a real-world impact on patients.
Additional Information:
Syneos Health is committed to equal opportunity and diversity. If your experience doesn’t match the job description perfectly, we encourage you to apply, as transferrable skills are valued.
Minimal travel may be required.
Apply Now to be part of a team that is changing lives and driving innovation in clinical development.
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