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Study Start-Up Specialist/Site Activation Partner - FSP

🇨🇦 Canada

Consulting

Management

GCP

Study Start-Up Specialist/Site Activation Partner - FSP

from 🇨🇦 Canada

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

TheSite Activation Partneris responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines andin accordance with prevailing laws, Good Clinical Practices, and sponsor standards.Other duties to include but not limited to: 

  • 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 andtimely escalation of Site issues where applicable 

  • Manage and coordinate with other supporting roles to ensuretimely 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) arerequired 

  • Accurately update andmaintain clinical trial systems that track site compliance and performance within project timelines 

  • Identify and resolve investigator site issues 

Experience required for this role: 

  • 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 

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by @maxrusakovic