Description

Single Sponsor Sr Project Specialist - UK only

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

• Set-up, maintain and close out project files and study information ((e.g., KPIs, regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.
• Maintain and distribute study-specific /financial reports (e.g. vendor/site invoices, investigator payments (grants and pass-through), forecasts, etc).
• May lead internal and external meetings as directed by the PL
• Prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure.
• Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PL. Assesses and communicates KPIs for associated job tasks to PL with proposed action plan. Prepares and provides status reports to customers with oversight from assigned PL
• Ensure all study documents are archived based on the appropriate guidelines and policy.
• May serve as project representative for internal and external audits. Provide support for quality assurance activities, including preparation for audits and internal review, preparing documentation and follow through to resolution actionable issues.
• May serve as primary customer contact when PL is out of the office. Seeks input from Project Director for customer support.
• May mentor and train Project Specialists