Syneos Health

Sr SSU & Regulatory Specialist, Belgrade

Location
Serbia, SRB
Salary
Competitive
Posted
13 Apr 2021
Closes
12 May 2021
Ref
21004267
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Here at Syneos Health we are currently recruiting for a Sr Study Start Up & Regulatory Specialist to be based in Belgrade (Serbia).

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
What we're looking for
  • 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

Get to know Syneos Health

We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:

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. 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.

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