Senior Site Activation Specialist

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Job Responsibilities

• Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules with moderate oversight from the SSU Country Manager. Works within the forecasted submission / approval timelines and ensures compliance, tracks milestone progress in the agreed SSU tracking system in real time; if forecasted timelines are not reached, investigates and provides clear rationale for delays, supports contingency plans and escalates the issue as soon as identified.
• Monitors basic financial aspects of the project and the number of hours / tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
• Supports continuous improvement of quality in all Site Start‑Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.).
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP / Sponsor requirements.
• Acts as the Local Submissions Specialist : follows the project direction provided by the designated country start‑up advisor (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 also be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with moderate oversight from the SSU Country Manager.
• May act as liaison and facilitator between investigational sites and functional leads for related tasks and / or issues, overseeing site activation end to end at the country / site level.
• Country Start‑Up Advisor : acts as a subject‑matter advisor for in‑country performance within the 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, e.g., Competent Authority submissions, EC submissions, notifications to data protection authorities, and other local / federal / national bodies. May provide support for data protection at the country level and give guidance on local requirements. Provides input in local SOPs and WI, supports creation of internal training materials, and assists 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 for individual studies based on trial requirements.
• May be asked to perform : Local Investigator Contract and Budget Negotiator – provides support to SAM to agree on country template contract and budget, produces site‑specific contracts from country template, supports negotiations with site, such as Site Contracts Service Centre and SAM with Sponsor, until resolution of issues and contract execution. Performs quality control, arranges execution of CTAs and archival of documents into repositories and capture of metadata.

Qualifications

Equal Opportunity Statement

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at One of our staff members will work with you to provide alternate means to submit your application.

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