Updated: Today
Location: Adelaide, SA, Australia
Job ID:25108836
Syneos Health is a leading fully‐integrated life sciences services organization built to accelerate customer success. We partner with innovators throughout the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members apply a drug development mindset, using years of experience and deep expertise to understand customer needs and shape tailored solutions. Whether in a Functional Service Provider partnership or a full‐service environment, you will collaborate with passionate problem solvers, innovate as a team and help our customers achieve their goals while driving meaningful impact for patients worldwide.
Job Responsibilities
* General – Responsible for country‐level quality deliverables, following project requirements and applicable country rules with minimal oversight from the SSU Country Manager. Forecasts submission and approval timelines, ensures compliance, monitors milestone progress, analyses delays, proposes contingency plans, escalates issues, monitors financial aspects, maintains SOP and WI compliance, ensures training records and timesheet compliance, and ensures all relevant documents are submitted to the Trial Master File (TMF) as required. Continuously improves quality of all Site Start‐Up (SSU) components at the country level, may be involved in vendor management.
* Local Submissions Specialist – Follows project direction from the designated Country Start‐Up Advisor (CSA) and PM/SAM, serves as primary point of contact for the PM/SAM during start‐up on allocated projects. Compiles and reviews essential document packages, collects essential documents from sites, prepares and submits Central EC, Local EC, RA applications, and other local regulatory or hospital approval submissions as required. Oversees ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, including safety notifications, with minimal oversight from the SSU Country Manager. Acts as liaison and facilitator between investigational sites and functional leads for related tasks and issues.
* Country Start‐Up Advisor – Acts as subject‐matter expert for in‐country performance within the Site Start‐Up, serving as country‐level intelligence on start‐up (SU) and clinical trial regulatory (CTR) activities. Maintains local regulatory intelligence on the central repository, provides guidance on data protection statements, supports creation of internal training materials, and identifies solutions for EC or CA issue resolution at the country level.
* Local Site ID and Feasibility Support – Provides support to the site selection lead and PM/SAM to ensure appropriate sites are selected for individual studies based on trial requirements.
* Local Investigator Contract and Budget Negotiator – Produces site‐specific contracts from the country clinical trial agreement (CTA) template, reviews and owns contracts, submits proposed CTA and investigator budget for site review, negotiates budget and contract with site via the Site Contracts Service Centre and SAM with Sponsor until resolution of issues, performs quality control, arranges execution of CTAs, archives documents into repositories and captures metadata.
* Line Management / Mentoring – Provides support to management in interviewing and selection, professional development, performance management, employee counseling and separations. Advises junior team members on administrative policies, technical problems, priorities and methods.
* Country Delivery Lead – Responsible for operational delivery across the country portfolio from participation through site start‐up to the first patient in. Analyzes country and site metrics to ensure baseline project deliverables are met, facilitates first patient in projections, performs operational site‐level planning and efficient allocation of resources within the country.
* Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.
Over the past 5 years, Syneos Health has worked with 94% of all novel FDA–approved drugs, 95% of EMA‐authorized products, and has contributed to over 200 studies across 73,000 sites and 675,000+ trial patients, delivering value to customers and patients worldwide.
Tasks, duties and responsibilities as listed herein are not exhaustive. The Company may assign other tasks, duties or responsibilities at its sole discretion. Equivalent experience, skills and/or education will also be considered. No statement herein creates an employment contract.
The Company is committed to compliance with the Americans with Disabilities Act and the EU Equality Directive, providing reasonable accommodations when appropriate to assist employees or applicants in performing the essential functions of the job.
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