The Site Activation Partner is responsible for leading and supporting operational activities from start-up to close-out, for assigned studies and investigator sites ensuring compliance with study and country deliverables, timelines and quality in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards.

Primary scope of work related to Regulatory, Ethics and Essential documents management activities through the life cycle of the study.

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

JOB 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 activation

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 execution of operational activities.

Support the compilation of the Central/and or Local 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/Local 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 in-scope activities in Shared Investigator Platform to align with Pfizer strategy

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 and approvals for protocol amendments,

FDA 1572/Attestation revisions,

Ethics Committee annual approvals

other regulatory 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 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

Utilize tools for efficient updates to study teams and SAP functional line 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 session with site personnel on Pfizer requirements to ensure ongoing compliance with study documentation in accordance with prevailing laws, Good Clinical Practices, and Pfizer standard

Identify and resolve investigator site issues timely; align with study team and local country colleagues on corrective and preventative actions

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 within a 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

May be considered for a Centralized EDR for IIP review (quality dependent)

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 independently use, and learn new systems

Microsoft Suite

Clinical Trial Management Systems (Veeva CTMS)

Veeva Suite

Electronic Trial Master File

Document exchange portals

Ethics, National Networks and Governing Bodies Portals and platforms (as needed)

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