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 within a country and may span over more than 1 country depending on the geographical region and business needs.

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
• 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 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 (where applicable) and other committees as per country requirements
• 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, submission through approval
• 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

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 maintenance of IRB/Ethics and other committee's activities as applicable.
• 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
• 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

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:

• A good understanding of the Site Activation requirements and processes within the country/region and be able to learn and potentially implement in more than one (1) country
• May be assigned as Site Activation Partner Point of Contact (PoC) on a study conducted in multi-country
• May be assigned as an SME on a system and/or process, and represent the SAP function as applicable
• May represent the SAP role on global initiatives
• Able to act as an SME on projects and initiatives, as requested
• Support the mentoring of new hires on processes/ systems

Systems & Tools

Ability to use and learn systems, and to use independently

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

QUALIFICATIONS / SKILLS

BASIC QUALIFICATIONS

• 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 in relating to colleagues and associates both inside and outside of the organization
• Good technical skills and ability to learn and use multiple systems

PHYSICAL/MENTAL REQUIREMENTS

• Demonstrated knowledge of clinical research and development processes, Key operational elements of a clinical trial, and ability to gain command of process details
• 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
• 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.

ORGANIZATIONAL RELATIONSHIPS

• Global Study Manager and Start-Up Project Manager, Global Study Clinician
• Local Site Relationship Partners and Director Clinical Site Operations, Clinical 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

RESOURCES MANAGED

• Not applicable

Work Location Assignment:Korea Remote

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