Study Start-Up Specialist – Site Activation Partner

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About the role

  • Site Activation Partner at Parexel leading operational activities for clinical trials and site compliance. Collaborating with regulatory groups and managing investigator site issues.

Responsibilities

  • Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation
  • Provide support to resolve issues or concerns and timely escalation of Site issues where applicable
  • Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
  • Collaborate with in country regulatory group, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required
  • Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
  • Identify and resolve investigator site issues

Requirements

  • School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred
  • Minimum 2 years relevant experience in Clinical Trials environment and clinical site activation.
  • Experience working in the pharmaceutical industry/or CRO is an asset
  • Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
  • Must be fluent in Local language and in English. Multi-language capability is an asset

Benefits

  • Health insurance
  • Professional development opportunities

Job type

Full Time

Experience level

JuniorMid level

Salary

Not specified

Degree requirement

Bachelor's Degree

Tech skills

Google Cloud Platform

Location requirements

RemoteCanada

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