Anastasiia Yermolaieva

*Collaborate across functional lines within CD&O and WRD, Contract Research Organizations (CROs), Functional Service Providers (FSPs), build and maintain effective relationships

* Build and maintain subject expertise and maintain internal process updates

*Act as a player coach within the Site Intelligence Specialist global and virtual community

* Act as a study specific central point of contact and coordinate the activities of other Site Intelligence Specialists while supporting the Site Intelligence Lead

*Perform tasks for multiple Site Intelligence and Feasibility projects

* Contribute to developing Site Feasibility plans and presenting the data to colleagues

*Maintain, verify, process, and make updates to PFE systems (including Registry), spreadsheets / documents as needed

*Provide country specific data (site contact, site recommendations) generated through collecting and interpreting feasibility data

* Manages Site IDs in Poland, Russia, Ukraine and UK by engaging with potential clinical sites and by reviewing internal and external intelligence on performance and quality metrics and performing literature research to identify investigators to build the database. Collects information supporting the definition of the ideal site for a study.

* Manages the generation and reporting of internal metrics for Study Optimization to support senior level discussions

* Acts a system administrator of Pfizer's Site Intelligence and Selection Tool to support the build of the investigator database and the collection of site intelligence data

* Supports the Site Intelligence Lead to ensure knowledge of the goals, scope and requirements of the Site Feasibility project and ensure that high quality results are delivered.

* Develops and maintains internal processes aimed to optimize country & site selection activities.

* Creates awareness by working as a cross functional team leader to deliver data analytics site intelligence initiatives with a variety of stakeholders, both internal and external. Initiatives will be diverse and may include technology and process improvement components.

* Runs operational and technical aspects of large global projects and assists with other Company systems activities related to the site intelligence.

* Promotes a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity

* Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitates effective portfolio delivery

* Certified Central Monitor accredited by the International Academy of Clinical Research (IAoCR) (via classes and workbook).

* Primary contact for project site personnel, in collaboration with the on-site CRA.

* Responsible for site management including; performance of remote site qualification, remote site initiation, remote interim site monitoring calls, ensuring regulatory, ICH-GCP and protocol compliance, and completes required actions as requested by clinical leads.

* Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.

* Responsible for ensuring correct IP receipt, handling and storage; knowledge of protocol, study procedures and adherence to the study Clinical Monitoring Plan; supporting subject/patient recruitment and retention strategies; collection, ongoing review, and maintenance of study documents to ensure accuracy, timeliness and completeness of the Trial Master file (TMF); remotely reviews electronic data and assist sites in resolving queries and/or other identified data issues.

* Monitors site performance metrics and with guidance implements action plans for sites not meeting expectations.

* Project Management and Clinical teams assistance with the migraine and spinal muscular atrophy studies

* Coordination and set up of internal and client meetings, preparation of agenda, meeting minutes and Action/Decision/Issues log

* Trial Master File management

* Cooperation with the Clinical team to ensure that selected sites have access to all required systems; Sites set up in the EDC and IWRS;

* Development and maintenance of project tracking tools and generation of the project status reports

* Temperature excursions assessments (Lift of the quarantines in the IWRS, communication with the sites, IMP use approval/disapproval )

* Reimbursement of investigators expenses for Investigators Meeting attendance

* Kick – off meeting attendance – administrative assistance with meeting materials preparation, meeting conduct, documentation of discussed actions and decisions

* Mentoring of new Project Associates

* Coordination of clinical trials focused on rheumatology

* Coordination of nursing department activities to ensure availability of appropriate laboratory and IMP supplies

* Assurance of the timely Case Report Form completion and query resolution

* Investigator Site File Maintenance, Filing and Archiving of the study documentation, preparation and collection of essential documents from site study team

* Patient eDairy/ ePRO Questionnaires Management

* Investigational Medicinal Product inventory, accountability, dispensation, Interactive Web Response System Management

* Filing and Archiving of the study documentation

* Assistance of the PI in development of materials necessary to appropriately train individuals involved into conduct of the trial

* Coordination and facilitation of the monitoring visits