• 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.

  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
  • 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 standards
  • 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 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
  • 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 use and learn systems, and to use independently

  • Microsoft Suite
  • Clinical Trial Management Systems (CTMS)
  • Electronic Trial Master File
  • Document exchange portals
  • 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 Care Partners and Director Clinical Site Operations, Country Operations 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

  RESOURCES MANAGED

  • Not applicable

  
  Work Location Assignment: Korea Remote

   
  Work Location Assignment: Remote

 
Work Location Assignment: Remote

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

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