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.

ROLE RESPONSIBILITIES
Clinical Trial Site Activation

• 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
• Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 572/Attestation Form, for internal regulatory approval within the required timelines
• Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
• Take the Lead, initiate and coordinates activities related to the compilation of high-quality IRB/EC package and ensure timely submission to approval (Central and or Local and in countries where applicable), and other committees as per country requirements
• Collaborate with in-country regulatory groups, and provide related/applicable site documents, as well as in countries where parallel submissions (Regulatory authority and ethics) are required
• Coordinate the timely communication, documentation and responses between Pfizer and Central Ethics committee to bring clinical study to approval (country dependent)
• Support investigators sites with local IRB workflow from preparation, and submission through approval
• Lead or 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 to align with Pfizer strategy as it relates to the role

• 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, re-approvals 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

• Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests
• Provide functional updates on a country and site level as required
• 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

• As needed, perform awareness sessions on Pfizer requirements with site personnel 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

• 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; 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

• 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

• 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
• Demonstrated deep knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
• 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

• Demonstrated knowledge and understanding of key operational elements of a clinical trial and processes (e.g., study start-up, conduct, close-out activities, reporting, etc.) and ability to gain command of these processes
• Understand the quality expectations and emphasis on right first time. Demonstrate compliance with all applicable company, regulatory and country requirements. Attention to detail evident in a disciplined approach
• Proven ability to work independently and also as a team member
• Ability to organize tasks, time and priorities, ability to multi-task
• Understand basic medical terminology, GCP requirements and proficient in computer operations.

• Flexible and adapt to off working hours in a global environment (when applicable)
• Possible Travel within area. May include some international travel

• Global Study Manager and Start-Up Project Manager, Global Study Clinician
• Local Site Relationship Partners and Director Clinical Site Operations, Country Trials Manager and other Local Roles
• Global Investigator Initiation Package (IIP) Regulatory Group
• Local Regulatory Manager, CTA Hub and CTA Submission Managers
• Site Intelligence Team
• Contract specialists
• Investigators Sites
• Country Ethics Committee representatives
• Other governing bodies representatives
• Local provincial/States and national networks