Site Start-Up

hace 4 semanas


Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo

About the Role

Syneos Health Clinical is seeking a highly skilled Site Start-Up & Regulatory Specialist I to join our team in Mexico. As a key member of our team, you will be responsible for providing quality on deliverables at the country level and following project requirements and applicable country rules.

Key Responsibilities

  • 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.
  • Monitors basic financial aspects of the project and the number of hours/tasks available per contract.
  • Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner.
  • Ensures all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Qualifications

  • Associate's Degree or equivalent combination of education and training.
  • Good understanding of clinical trial process across Phases II-IV and ICH GCP.
  • Ability to interact effectively and appropriately with investigative site personnel.

Why Syneos Health Clinical

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.


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