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About the Role

Syneos Health is a leading life sciences services organization that partners with innovators across the drug development and commercialization continuum. The Clinical Solutions team applies deep expertise to understand customer needs and shape solutions. Team members collaborate in agile, driven environments to help customers achieve their goals.

Responsibilities

• Responsible for quality deliverables at the country level, following project requirements and applicable country rules with moderate oversight.
• Works within forecasted submission/approval timelines, ensuring compliance and tracking milestone progress.
• Investigates and provides rationale for delays, supports contingency plans, and escalates issues.
• Monitors basic financial aspects of the project and available hours/tasks, escalating discrepancies.
• Reviews and complies with SOPs and WIs, keeps training records updated, and ensures timesheet compliance.
• Supports continuous improvement of quality in all Site Start-Up (SSU) components at the country level.
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
• Responsible for the Local Submissions Specialist, following project direction from CSA and SAM.
• May serve as a point of contact for the PM/SAM during start-up on allocated projects.
• Complies and/or reviews essential document packages for site activation and may be involved in essential document collection from site.
• Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authority or hospital approval submissions.
• Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities.
• May act as liaison and facilitator between investigational sites and functional leads.
• Oversee site activation end to end process at country/site level.
• Acts as Subject Matter Advisor for in-country performance within Site Start-Up.
• Supports country-level intelligence on start-up (SU) and clinical trial regulatory (CTR).
• Ensures local country regulatory intelligence is maintained on the central repository.
• May provide support for data protection at the country level and guidance on data protection statements.
• Provides input in local SOPs and WIs.
• Supports the creation of internal training materials on local legislation requirements.
• Provides input to the team to assist with EC or CA issue resolution at the country level.
• Provides support with site selection lead and PM/SAM to ensure appropriate sites are selected.
• May be asked to perform Local Investigator Contract and Budget Negotiator duties.
• Produces site-specific contracts from country template.
• Provides support in submissions for proposed contract and budget for site.
• Provides support in negotiating budget and contract with site until resolution of issues and contract execution.
• Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.

Requirements

• Bachelor’s Degree
• Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
• Ability to understand clinical protocols and associated study specifications.
• Detailed understanding of clinical trial start-up processes.
• Ability to manage external vendors to contract effectively.
• Strong organizational skills with ability to handle multiple tasks effectively.
• Strong written and verbal communication and interpersonal skills.
• Ability to manage multiple project budgets with increased complexity and value.
• Quality-driven in all managed activities.
• Good negotiating skills.
• Good problem-solving skills.
• Demonstrated ability to work independently as well as part of a team.

Education Level

• Bachelor’s Degree

About the Company

• 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.
• Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
• No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Equal Opportunity

• The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
• Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.