Prune Navarro

Experience

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  Sanofi Pasteur

  Feb 2008 - Aug 2008

  Trainee Engineer in Vaccine Development, Formulation & Stability

  High-Throughput Formulation Screening project (HTFS): Transfer of HTFS technology from Toronto to Marcy l'Etoile. Set-up and application of high-throughput formulation screening techniques for vaccines.

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  IQVIA

  May 2009 - Apr 2012

  Clinical Data Manager

  Project management & oversight of Biometrics operations (Phase I to III clinical trials):- Management of industry clients and third party vendors : End-to-End delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, to client satisfaction. - Lead of project planning, execution, and close-out; financial management; communications; and milestone deliverables- Project financial management, support to business development and contract teams- Lead of cross functional teams, assessment of resources need and risk management - Writing, review, maintenance and respect of core documentations and processes- Oversight of data related operations- Ensure high quality of deliverables- Process improvement- Compliance with Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.Therapeutic area: - Oncology- Cardiovascular- Immunology Show less

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  Transgene

  May 2012 - Jul 2014

  Clinical Data Manager

  Lead Clinical Data Manager for multi-centric international studies (Phase I, Phase II and Non-interventional studies) from set-up to database lock:- Member of the core clinical team (medical, regulatory, pharmacovigilance, clinical science and statistics)- Provided input from the protocol synopsis writing to the CSR (trials sponsored by Transgene, co-sponsored or investigator led)- Responsible for the timelines, budget and quality of several trials in parallel- Ensured compliance with the Good Clinical Practices (GCP), applicable regulatory guidelines, SOPs, policies, and, where available, CDM guidance documents.- Clinical Data SME CRO management:- Contributed to the CRO selection process (bid-defense meetings)- Main point of contact for the purchase and legal departments (RFI, RFP, budget/change order/invoice reviews)- Daily CRO oversight until project close-out Transversal projects: - Member of the SOP reflexion group (process improvement, SOP writing and review)- IT innovation: in-house clinical database implementation- Data standardization (FDA and EMA compliance) Therapeutic area: - Infectious Diseases (HCV)- Oncology (CRC, HCC, NSCLC) Show less

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  Roche

  Aug 2014 - now

  - Project management for the acquisition of non-CRF data during set-up, conduct and close-out phases of multiple studies in Neuroscience and Inflammation programs- Lead end-to-end non-CRF clinical data deliverables, including scope/requirements and data flow definition, timelines, risks and coordination of cross-functional tasks- Ensure adherence to non-CRF data collection standards in accordance to CDISC; participate in the development of new data collection standards for new and complex Non-CRF data types- Oversee Functional Service Provider execution of tasks per Roche processes- Vendors management: IxRS, eCOA, Labs, Biomarkers, PK/ATA, ECG, Imaging (PET, MRI)- Lead functional work initiative: Non-CRF Data Quality business process / tool implementation- Participate in Pharma Data Governance working group, for Alzheimer's Disease and Multiple Sclerosis indications (Roche cross-functional team working on the creation of Biomedical Data Standards, focus on Non-CRF data) Show less - Created awareness and understanding, and ensured the quality and reliability of information used to enable decisions with Clinical Operations Leaders and stakeholders. - Collaborated with Clinical Operations study management teams to identify and resolve data quality issues and conducted root cause analysis into underlying issues that impact decision making.- Managed and reported accurate safety and regulatory information in collaboration with Regulatory teams to ensure pharma wide real time regulatory compliance. Show less - Interacted with internal and external stakeholders and coordinated the execution of internal processes related to engagement with Healthcare professionals, Grants, Sponsorships and Donations, and Medical Education as per SOPs and compliance guidelines.- Acted as the expert for the on-line tool (iHCP) that tracks approval and spend on Healthcare professionals- Acted in compliance with all laws, regulations and policies. Knowledge of Sunshine Act, APBI Code and EFPIA regulations to adequately support customers. Show less

  • RBQM Surveillance Lead

    Apr 2024 - now

  • Senior Data Sciences Product Leader - Data Strategy & Delivery, Data Sciences

    Apr 2019 - Apr 2024

  • Senior Non-CRF Data Acquisition Specialist - Clinical Data Management, Biometrics

    Sept 2016 - Apr 2019

  • Data Specialist - Data Standards & Data Quality, Product Development Clinical Operations

    May 2015 - Aug 2016

  • Global Healthcare Process Coordinator - Global Pharma Procurement, Strategy Realization & Operations

    Aug 2014 - Apr 2015