Job Summary

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 Pfizer standards. Responsibility span within a country or multi-country depending on the geographical region and business needs.

Main 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
• Provide support to resolve issues or concerns and timely escalation of Site issues where applicable
• Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, for internal regulatory approval within required timelines
• Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
• Collection of documents needed from sites for EU-CTR submission. Assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures
• Support & implement activities in Shared Investigator Platform (SIP) to align with Pfizer strategy as it relates to the role

Clinical Trials Conduct

• Post site activation, initiate and coordinate activities and essential documents management with the investigator’s sites towards the compilation of a high-quality documents 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 continuation of IRB/Ethic’s and other committees activities Post SIV, and related submission, notifications, reapprovals etc.
• Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness ·
• Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines ·
• Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections

Internal & External Communication

• Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests
• Attend study Start-up meeting and provide functional updates on a country and site level ·
• Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals ·
• Disseminate Central or Local Ethics Approval to study team and Investigator Sites where applicable
• Communicate Local sites approvals to study team members and stakeholders

Clinical Trial Site Support

• As needed, perform, awareness session with site personnel on Pfizer requirements and to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards
• Identify and resolve investigator site issues within required timeframes; align with study team and local country colleagues on corrective and preventative actions to close open issues and to prevent recurrence / persistence of issues

Additional Responsibilities

Deep understanding of the Site Activation requirements and processes within the country and be able to develop and implement in more than one (1) country to enable multi-country coverage.

Assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multi-country:

• Represent the SAP role on the study o Take the lead in the compilation and preparation of the Investigator Initiation Package (IIP) Template for the study and share with SAP team globally
• Communicate with SAPs globally on study information and timelines
• Be an SME on one or more system and/or process, be the go-to person and train the SAPs on these respective systems or processes
• Represent the SAP role on global initiatives
• Able to act as an SME on projects and initiatives, as requested ·
• Mentor for new hires on processes, systems and SAP activities facilitating and optimizing the time from hire/training to assignment on a study ·
• Able to manage a high volume of, complex studies and sites

Systems & Tools

Ability to use and learn systems, and to use independently

• Ethics, National Networks and Governing Bodies Portals and platforms
• Electronic Investigator Site File (e.g. Florence)
• Microsoft Suite · Clinical Trial Management Systems (CTMS)
• Electronic Trial Master File
• Document exchange portals
• Shared Investigator Platform

Basic Qualifications

• School diploma/certificate with equivalent combination of education, training and experience; BS/BA or bachelor’s degree in life sciences preferred
• Minimum 4 years relevant experience in Clinical Trials environment and clinical site activation. Experience working in the pharmaceutical industry/or CRO is an asset
• Must be fluent in Local language and in English.
• Multilingual capability is an asset
• Effective verbal and written communication skills relating to colleagues and associates both inside and outside of the organization
• Good technical skills and ability to learn and use multiple systems
• Experience working in a global environment ·
• Experience in working in more than 1 country is an asset
• Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives