Site Activation Partner (Sr. Associate)

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)

QUALIFICATION / SKILLS

• 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 both inside and outside of the organization
• Strong 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
• Demonstrated strong 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 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.

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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Medical