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
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 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
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 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
Additional Responsibilities:
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
Systems & Tools
Ability to use and learn systems, and to use independently
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
BASIC QUALIFICATIONS
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
PHYSICAL/MENTAL REQUIREMENTS
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.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Flexible and adapt to off working hours in a global environment (when applicable)
Possible Travel within area. May include some international travel
ORGANIZATIONAL RELATIONSHIPS
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
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer
Work Location Assignment: Remote - Field Based
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Medical
Argentina
