Warsaw, Mazowieckie, Poland
● Perform due diligence on grant requestor, ensure the requesting organization and/or the grant requester is not listed on any national, international, or internal exclusions lists. Verify accreditation at the organization level or at the activity level when applicable, and review grant request for accuracy and completeness. ● Coordinate request review process including setting approval workflow and preparing necessary review documents. Ensure Reviewer/Approver reference table is up to date. ● Complete/support any necessary further due diligence activities such as anti-bribery and corruption processes. ● Partner with medical reviewers and approvers to allocate payment and set milestones. Select the appropriate contract template for signature and execution. ● Liaise with external stakeholders and local legal colleagues to ensure acceptance and execution of the grant contract. ● Manage financial transactional details as well as drug supply requests based upon executed contract and milestone payments; work with Pharmaceutical Sciences colleagues and other internal stakeholders to ensure clinical supply forecasts are up-to-date and supplies are available as required. ● Manage regular program oversight activities for enrollment, IRB approval/renewals, and progress. Forward program update documentation to the appropriate reviewers and release milestone payments as applicable. ● Assist PCO and HQ colleagues with status reports, queries, and other support as required. ● Partner with global team and contribute to process and business technology improvement projects within areas of responsibility, as requested.
● Serving customers, providing advice on drug interactions, usage and dosing ● Evaluation of prescriptions ● Pharmacy accounting, monitoring stock levels and ordering pharmaceutical drugs
● Provide phone support to HCPs and consumers regarding AEs, PQCs, medical inquiries, product support and other needs as required ● Receive, triage, review and process Lifecycle safety operational data ● Perform data entry for tracking and Lifecycle safety databases, coding relevant medical terminology, writing descriptive narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations ● Receive and document incoming telephone calls or emails from investigative sites or other sources reporting safety data
● Administration, coordination, and management of delegated study activities ● Coordination of responses from clinical service providers to queries ● Assisting in the on-site Monitoring Visit ● Assisting project teams with the maintenance of clinical study documentation (e.g., Study Files) in accordance with GCP and study-specific requirements ● Coordinating document translation from the local language ● Preparing, reviewing, and submitting documents to Local Ethics Committees ● Assisting with standard metric reporting and distribution ● Complying with ICH/GCP, IATA, Data Privacy, and other appropriate regulations ● Working with internal partners and external vendors, including Contract Research Organizations (CROs) and Academic Research Organizations (AROs), for outsourced trials/activities ● Monitoring the flow of incoming study documents ● Planning and coordinating internal and external meetings, drafting minutes and agendas, documenting outcomes, and following up on related actions ● Reviewing and managing the Trial Master File (TMF) for completeness and ensuring timely provision of TMF content across responsible functions, including document filing and QC ● Assisting the Project Manager in reviewing and updating the Project Decision/Action/Issue Log ● Granting and revoking study system access for new team members ● Assisting with CRA/SMA tasks, including document collection from sites and generating study reports ● Coordinating various tracking reports, including team member tracking and training
Participant: ● BraveCamp (sponsored by Pfizer) | Feb. 2023 ● Biotech Leaders Academy by Roche | Oct. - Dec. 2021