Site Activation Partner
Parexel
full-time
Posted on:
Location Type: Remote
Location: Canada
Visit company websiteExplore more
Tech Stack
About the role
- Leading or supporting operational activities from start-up to close-out for assigned studies and investigator sites
- 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.
- 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
- Flexible working 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 methodologiessite activationinvestigator initiation package (IIP)issue resolutioncompliance trackingperformance trackingregulatory submissionsethics submissionsICH/GCPFDA regulations
Soft Skills
leadershipcollaborationcommunicationproblem-solvingorganizational skillstimely escalationsupportcoordination