SITE ACTIVATION PARTNER

ROLE 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 & Conduct -Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to sites initiation approval -Register investigator sites in Pfizer registries and systems as required.
Update and regularly maintain the registry with accuracy and have it inspection ready -Work directly and interact with investigator sites to complete critical information and readiness for site activation; inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, study contracts contacts, clinical supply shipment information, payment information, IRB submission and status -Take the lead to resolve issues or concerns and timely escalation of issues where applicable -Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA revisions, for internal regulatory approval within required timelines -Lead a subset and assist with the overall site activation process and coordinate operational activities to ensure timely site activation -Take the Lead and Coordinates the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study -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 preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information as needed -Initiate and coordinate activities and essential documents management with the investigator`s sites (post SIV) during study conduct 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 revisions, Ethics Committee annual approvals -Responsible for timely filing of documents to Trial Master File and other systems and assist with periodic quality review of study files for accuracy and completeness -Accurately update and maintain clinical systems that track site compliance and performance within project timelines -Lead or assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
-Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections Communication -Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests -Attend study Start-up meeting and provide functional updates on a country and site level -Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals -Disseminate Central Ethics Approval to study team and Investigator Sites -Communicate Local sites approvals to study team members and stakeholders Il presente annuncio è rivolto ad entrambi i sessi, ai sensi delle leggi e , e a persone di tutte le età e tutte le nazionalità, ai sensi dei decreti legislativi e .