Site Activation Partner I – FSP, Fixed-Term 7 months

🔥 16 hours ago

🇨🇦 Canada – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🪙 Affiliate Manager

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Lead or support operational activities from study start-up through close-out for assigned studies and investigator sites • Ensure compliance with study timelines, prevailing laws, Good Clinical Practices, and client standards • Initiate and coordinate start-up activities and essential document management toward high-quality Investigator Initiation Packages and site initiation approval • Resolve or escalate site issues and coordinate supporting roles for timely site activation • Prepare, validate, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms • Support Central Investigator Review Board packages and country-required committee submissions • Coordinate communications and responses between clients and central ethics committees • Support investigator sites through local IRB preparation, submission, and approval workflows • Prepare, handle, and distribute clinical documentation and reports • Support and implement Shared Investigator Platform activities aligned with client strategy • Manage essential documents and updates throughout study conduct, including protocol amendments, FDA 1572/Attestation revisions, and ethics committee annual approvals • Maintain IRB/Ethics Committee activities • File documents to the Trial Master File and assist with periodic quality reviews • Update and maintain clinical trial systems tracking site compliance and performance • Support investigator sites and study teams with audit and inspection responses • Maintain ongoing communication with study teams and investigator sites • Provide country- and site-level functional updates and establish tools for efficient status reporting • Disseminate ethics approvals and communicate local site approvals to stakeholders • Conduct site personnel awareness sessions as needed • Identify and resolve site issues and coordinate corrective and preventive actions • Serve as a Site Activation Partner point of contact or subject matter expert as assigned • Represent the SAP function on systems, processes, and global initiatives • Mentor new hires on processes and systems • Complete required training, timesheets, expense reports, and CV updates • Maintain knowledge of and comply with Parexel processes, ICH-GCP, and applicable requirements

🎯 Requirements

• At least 2 years of start-up experience and experience with US/CAN • Knowledge of clinical research and development processes and key operational elements of a clinical trial • Understanding of quality expectations and a right-first-time approach • Compliance with applicable company, regulatory, and country requirements • Attention to detail and disciplined approach • Ability to work independently and as a team member • Ability to organize tasks, time, and priorities and multitask • Basic medical terminology knowledge • GCP requirements knowledge • Proficiency in computer operations • Ability to learn and independently use systems • Proficiency with Microsoft Suite • Experience with Clinical Trial Management Systems (CTMS) • Experience with electronic Trial Master File and electronic Investigator Site File systems (e.g. Florence) • Experience with document exchange portals, Shared Investigator Platform, and ethics, national networks, and governing bodies portals/platforms as needed • Flexibility to work off-hours in a global environment when applicable • Ability to travel as needed, including possible international travel • Experience working in the pharmaceutical industry or CRO in study site activation preferred • Knowledge of clinical trial methodologies, ICH/GCP, FDA, and global and local country regulations • Fluency in the local language and English required • Multilanguage capability preferred • For individuals based in Canada, bilingualism in French and English preferred • Effective verbal and written communication skills • Good technical skills and ability to learn and use multiple systems • School diploma or certificate with equivalent combination of education, training, and experience, or Bachelor of Science/Bachelor of Arts or equivalent • Minimum 2 years relevant experience in clinical site management

🏖️ Benefits

• 7-month temporary assignment with the potential to transition into a full-time role • Full-time employment • Potential international travel