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 RESPONSIBILITIESClinical 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 1572/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, reapprovals 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
QUALIFICATIONS / SKILLSBASIC 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 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
Work Location Assignment: RemotePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Medical#LI-PFE