Site Activation Manager​/Clinical Operations Manager FSP

FSP 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.

• 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.

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, client policies and procedures, quality standards and adverse event reporting requirements internally and externally. The person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

Responsibilities include, but are not limited to:

• Ownership of country and site budgets.
• Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
• Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out.
• Oversees FCPA, DPS/OFAC, and maintenance of financial systems.
• Financial forecasting in conjunction with SCOM /other roles.
• Executes and oversees clinical trial country submissions and approvals for assigned protocols.
• Develops local language materials including local language Informed Consents and translations.
• Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
• Manages country deliverables, timelines and results for assigned protocols to meet country commitments.
• Responsible for quality and compliance in assigned protocols in country.
• Contributes to the development of local SOPs.
• Oversees CTCs as applicable.
• Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
• Collaborates closely with Headquarter to align country timelines for assigned protocols.
• Provides support and oversight to local vendors as applicable.
• Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management.
• Enters and updates country information in clinical and finance systems.
• Ownership of local regulatory and…