Site Activation Partner I

工作内容

Role Summary

The SiteActivationPartneris responsible for leading and supporting operational activities from start-up to close-out, for assigned studies and investigator sites. Ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.

Role Responsibilities

Clinical Trial Site Activation

• Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation
• Prepare, validate, and submit regulatory documents such as completed Investigator Package, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
• Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
• Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study and other committees as per country requirements
• Coordinate the timely communication, documentation and responses between Pfizer and Ethics committees to bring clinical study to approval (country dependent)
• Collaborate on the development and readiness of sites eISF when utilized
• Support & implement activities in Shared Investigator Platform to align with Pfizer strategy
• Coordinate translation of documents that are within scope with the preferred translation vendors
  

Clinical Trials Conduct

• Post site activation, initiate and coordinate activities and essential documents management and updates through the life cycle of a study such as the documents management for protocol amendments, FDA 1572/Attestation revisions, Ethics Committee annual approvals and other activities required during study conduct
• Ensure maintenance of IRB/Ethics and other committees’ activities as applicable
• Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review
• Accurately update and maintain clinical trial systems
  

Systems & Tools

Ability to use and learn systems, and to use independently, such as:

• Microsoft Suite
• Clinical Trial Management Systems (CTMS)
• Electronic Trial Master File
• Shared Investigator Platform
• Ethics and Governing Bodies Portals and platforms (as needed)
  

Basic Qualifications & 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 site management.
• Experience working in the pharmaceutical industry/or CRO in study site activation 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. Multilanguage capability is an asset
• For individuals based in Canada: Bilingualism (French, English) is an asset
• Effective verbal and written communication skills
• Understand the quality expectations and emphasis on right first time.
• Ability to work independently and as a team member
• Ability to organize tasks, time and priorities, ability to multi-task
• Flexible and adapt to off working hours in a global environment (when applicable)
  

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical