Site Activation Partner - FSP

Parexel • Quebec, ON

3d

About The Position

The Site Activation Partner I is 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 and in accordance with prevailing laws, Good Clinical Practices, and sponsor standards. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

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

Nice To Haves

• Multi-language capability is an asset

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees