Here at Syneos Health we are currently recruiting for a Study Start Up & Regulatory Specialist II.  

Main responsibilities:

• Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. 
• 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 they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached:  investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, 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.).
• Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.
• Responsible for one or more of the following functions at the country level:
  • Local Submissions Specialist
  • Country Start-Up Advisor
  • Local Site ID and Feasibility Support
  • Local Investigator Contract and Budget Negotiator 

To succeed in this role you will need the following skills/experience:

• Minimum of 2-3 years’ experience in a similar role in the industry
• Degree educated or equivalent combination of education and relevant experience.
• Detailed understanding of the clinical trial process across Phases II-IV and ICH GCP
• Ability to understand clinical protocols and associated study specifications.
• Ability to manage multiple project budgets with increased complexity and value
• Ability to external vendors to contract effectively.
• Demonstrated ability to work well independently as well as part of a team.
• Ability to manage time to organize and prioritize work and meet deadlines in a dynamic environment.
• Fluent in English and local language

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. 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.