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Senior Clinical Trial Operations Specialist

2 months ago

Melbourne, Victoria, Australia Syneos Health - Australia Full time
About Syneos Health - Australia

Syneos Health is a leading biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model puts the customer and patient at the center of everything we do, simplifying and streamlining our work to make Syneos Health easier to work with and for.

Job Responsibilities

As a Senior Clinical Trial Operations Specialist, you will be responsible for delivering high-quality results at the country level, following project requirements and applicable country rules with minimal oversight from the SSU Country Manager. You will forecast submission/approval timelines, ensure compliance, and track milestone progress in real-time. If forecasted timelines are not reached, you will analyze data to provide clear rationale for delays, provide contingency plans to mitigate impact, and escalate the issue as soon as identified.

You will also monitor financial aspects of the project and the number of hours/tasks available per contract, escalating discrepancies in a timely fashion. You will review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeping training records updated accordingly and ensuring timesheet compliance. You will ensure all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements.

You will be responsible for one or more of the following functions at the country level:

  • Local Submissions Specialist: Follows the project direction and expertise provided by the designated country start-up advisor (CSA) and PM/SSUL. May serve as the primary point of contact for the PM/SSUL (or designee) during start-up on allocated projects. Compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from site.
  • Oversees 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 minimal oversight from the SSU Country Manager.
  • Country Start-Up Advisor: Acts as Subject Matter Expert for in-country performance within the Site Start-Up. Acts as country-level intelligence on start-up (SU) and clinical trial regulatory (CTR). Ensures that local country regulatory intelligence, as it pertains to the activities of the local SU and CTR team, is maintained on the central repository.
  • Local Site ID and Feasibility Support: Provides support site selection lead and PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
  • Local Investigator Contract and Budget Negotiator: Produces site-specific contracts from country clinical trial agreement (CTA) template. Reviews and owns site-specific contracts from country template. Submits proposed CTA and investigator budget for site review. Negotiates budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues.
  • Line management / mentoring responsibilities: As part of developmental plans, it may be requested to provide support to management in activities such as interviewing and selection, professional development, performance management, and employee counseling and separations.
Qualifications

We are looking for a highly skilled and experienced professional with:

  • Bachelor's Degree
  • Excellent understanding of clinical trial process across Phases II-IV and ICH GCP
  • Good understanding clinical protocols and associated study specifications
  • Excellent understanding of clinical trial start-up processes
  • Project management experience in a fast-paced environment
  • Good vendor management skills
  • Strong organizational skills with proven ability to handle multiple projects
  • Excellent communication, presentation, and interpersonal skills
  • Quality-driven in all managed activities
  • Strong negotiating skills
  • Strong problem-solving skills
  • Ability to mentor, lead, and motivate more junior staff
  • Demonstrate an ability to provide quality feedback and guidance to peers
  • Contribute to a training and Quality assurance plan within SSU and update SOPs/WI
About Us

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. We are a highly competitive and ever-changing environment that encourages initiative and challenges the status quo. Learn more about Syneos Health.