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

🔥 1 hour ago

🌐 Mexico, Argentina, +1 more countries – Remote

🇲🇽 Mexico – Remote 🇦🇷 Argentina – Remote 🇧🇷 Brazil – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🪙 Affiliate Manager

👻 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 • Initiate and coordinate activities and essential document management for Investigator Initiation Packages and site activation • Register and maintain investigator sites and client stakeholders in client registries and systems • Interact with investigator sites to confirm start-up readiness and review site profiles, essential documents, contracts, supplies, payments, and IRB information • Resolve and escalate site issues within required timelines • Prepare, validate, and submit regulatory documents for internal approval • Coordinate supporting roles and activities to ensure timely site activation • Support Central and local IRB/Ethics Committee packages, submissions, communications, and approvals • Assist with non-clinical trial supplies, tracking, clinical documentation, filing, and archiving • Support electronic Investigator Site File readiness and manage access before Site Initiation Visits • Coordinate in-scope document translations • Manage study documents and updates throughout study conduct, including protocol amendments, FDA 1572/Attestation revisions, and annual Ethics Committee approvals • File documents to the Trial Master File and support quality reviews and audits/inspections • Maintain clinical trial systems tracking site compliance and performance • Communicate study, country, and site updates, approvals, issues, delays, and escalations to stakeholders • Provide site personnel awareness sessions on client requirements and compliance • Complete assigned training and adhere to EP and client SOPs and processes • Learn and potentially implement site activation processes across more than one country • Potentially serve as study Point of Contact, Subject Matter Expert, global initiative representative, or mentor

🎯 Requirements

• At least 2 years of experience in start-up working with US/Canada • Minimum 3 years’ relevant experience in clinical site management, working with US/Canada • School diploma/certificate with equivalent combination of education, training and experience • Knowledge of clinical trial methodologies, ICH/GCP, FDA, and global and local country regulations • Effective verbal and written communication skills • Good technical skills and ability to learn and use multiple systems • Knowledge of clinical research and development processes and key operational elements of a clinical trial • Ability to understand quality expectations and demonstrate compliance with 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 • Understanding of basic medical terminology and GCP requirements • Proficient in computer operations • Fluency in the local language and English • Bachelor of Science, Bachelor of Arts, or Bachelor’s in Life Sciences preferred • Experience working in the pharmaceutical industry or CRO in study site activation preferred • Multilanguage capability preferred

🏖️ Benefits

• Potential to transition into a full-time role after the 7-month temporary assignment • Client- and EP-provided training, including general training requirements, SOPs, system and process-related training • Potential mentoring and subject matter expert opportunities • Participation in global initiatives • Opportunity to support mentoring of new hires