Site Activation Partner/Study Start Up Specialist - FSP

Résumé du poste

The Site Activation Partner leads operational activities from study start-up to close-out to ensure compliance with timelines and regulatory standards. They coordinate essential document management, manage site initiation packages, and resolve investigator site issues to ensure successful trial activation.

Détails du poste

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. The Site Activation Partner 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. Other duties to include but not limited to: 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 Experience required for this role: 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 #LI-LO1

Ce que vous ferez

The Site Activation Partner leads operational activities from study start-up to close-out to ensure compliance with timelines and regulatory standards. They coordinate essential document management, manage site initiation packages, and resolve investigator site issues to ensure successful trial activation.

Exigences

Candidates must have at least 2 years of relevant experience in clinical trials and site activation within the pharmaceutical or CRO industry. A bachelor's degree in life sciences is preferred, along with strong knowledge of ICH/GCP, FDA, and global regulatory requirements.

Compétences indiquées

• Regulatory Compliance · Souhaitée
• issue resolution · Souhaitée
• Gestion de projet · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Clinical Trials
• Site Activation
• Regulatory Compliance
• Good Clinical Practices
• ICH/GCP
• FDA Regulations
• Document Management
• Investigator Initiation Package
• Clinical Trial Systems
• Project Management
• Stakeholder Coordination
• Issue Resolution
• Empathy
• Ethical Standards And Conduct
• Management
• Pre-Clinical Development
• Consulting
• English Language
• Good Clinical Practices (GCP)
• Life Sciences
• Pharmaceuticals

Domaines d’emploi

• Healthcare
• Science & Research
• Consulting
• Site Activation Lead
• Clinical Trial Manager
• Research and Development Managers
• Clinical Research Coordinators
• Natural Sciences Managers