Site Activation Partner – FSP
Parexel
full-time
Posted on:
Location Type: Remote
Location: Canada
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Tech Stack
About the role
- Responsible for leading or supporting operational activities from start-up to close-out for assigned studies and investigator sites
- Ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and sponsor standards
- 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 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
- Competitive salary
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial methodologiesinvestigator site activationGood Clinical Practices (GCP)ICH guidelinesFDA regulationsdocument managementsite compliance trackingperformance trackingissue resolutionproject timeline management
Soft Skills
leadershipcollaborationcommunicationproblem-solvingorganizational skillstimely escalationsupportcoordinationattention to detailadaptability