Oncology Project Coordinator - Madrid, España - Pfizer

Pfizer

Empresa verificada

Madrid, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

The Project Coordinator is responsible to manage medical projects in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations.

The Project Coordinator will plan and pro-actively work in multidisciplinary teams (including Legal, Compliance, Medical Quality Governance, Supply Chain, Demand Planning, Finances, etc.) to ensure key milestones are achieved and medical projects are performed within budget, on schedule and in compliance with the appropriate quality standards.

Main responsibilities:

To coordinate nonclinical medical projects:
To manage donations, educational programs, publications, advisory boards projects and third party contracts in accordance with internal procedures (managing contract with foundations, getting internal approvals, following the project development, etc.) ensuring that MAPP and SOPs requirements are followed.
To manage and organize local advisory boards including logistics management:
To comply and ensure that all internal requirements and approvals are fulfilled
To enter all required data and upload documents in Mapp Navigator submission and approval
To ensure contracts with advisors are prepared and signed before the advisory board
To track payments to advisors and making financial reconciliation
To ensure that projects, including Educational Programs, Publications, Business Donations are delivered ontime, within scope and within budget and in compliance with applicable quality standards
To develop and maintain Project Plans and timelines for their project and track progress
To measure and evaluate project performance
To facilitate internal and external communication
To establish and maintain relationship with third parties/vendors (arranging meetings to present and consider different budgets, collaborating with the development of the contract, ensuring that they are trained in pharmacovigilance matters and following all the quality requirements to contract them).
To contribute in review/develop procedures, guidelines, SOPs, metrics as needed
To collaborate in training to medical colleagues about internal SOPs and procedures (Educational Programs, Publications, Advisory Boards, Donations, Compassionate Use Programs, etc)
To support Grants development (including ISRs, GR, IMEs and Qis) together with the Research Manager from the legal agreement signature to clinical supplies management all through the project.
To ensure that ISRs projects are delivered ontime, within scope and within budget and in compliance with applicable quality standards. Drug management/supplies, shipment of samples, etc.
To update Cybergrants
To support Audits: preparation, development, followup and remediation plan together with the ISR Manager
To contribute in review procedures, guidelines, SOPs, metrics as needed in collaboration with the ISR Manager
To support Non-Interventional studies (NIS).
To collaborate in the planning and development of NIS studies planning and management. Ensure that projects are delivered ontime, within scope and within budget and in compliance with applicable quality standards in collaboration with the Medical Advisor and the Clinical Research Associate (CRA) involved
Study submission to Ethics Committes, Health Authorizations, Contracts with sites.
Site initiation Visits, Site monitoring visits and closeout visits
Investigator meetings
Payments to institutions and investigators
High knowledge in systems Siebel, CCTR, GDMS, CAL to support the development of NIS
To support the compassionate use access to a Pfizer investigational product, as Palbociclib, Lorlatinib, Talazoparib, Crizotinib and Elranatamab, to stablish and request the needs of clinical supplies, management and forecast quarterly or as needed.
Review if the patient is eligible for compassionate access
Management of initial documentation and resupplies
Follow Spanish Agency authorizations for each patient
Control the tool PfizerCARes and the Spanish Agency website
Transition from noncommercial to commercial medication
To support to the Oncology Medical Budget and Phasing.
To manage the project budget, profitability and ensure invoicing is performed on time and in accordance with the scope of work
To collaborate with Medical Advisors in thedevelopment of the Medical Operating Plan for the product on the basis of identified local opportunities, supporting development activities in support to the relevant therapeutic area in alignment with BU strategies
To coordinate the management of oncology phasing working with Medical Advisor, Medical Scientific Liaison, Medical Head and Finance Controller
To update the Project Management tool when it is required by the Regional Finance Lead in order to enter the local amounts and to follow up the different Last Estimated