Qiaoli (Lily) Chen

Experience

• 

  Iowa State University

  Aug 2003 - May 2007

  Research/Teaching Assistant
• 

  North Central Regional Center for Rural Development

  Sept 2006 - May 2007

  Research Assistant
• 

  Boston Children's Hospital

  Jan 2008 - Mar 2013

  • Managed two direct reports: a statistical programmer and a junior data manager.• Drafted and negotiated the data management budget and the scope of work with clients.• Led the data standardization committee to promote the CDISC standards in the hospital.

  • Senior Clinical Data Manager

    Oct 2010 - Mar 2013

  • Clinical Data Manager

    Jan 2008 - Sept 2010
• 

  Synta Pharmaceuticals

  Apr 2013 - Nov 2013

  Clinical Data Manager

  Led DM activities on a phase 2 breast cancer trial and a phase 2/3 lung cancer trial.

• 

  Novartis

  Feb 2014 - Jun 2017

  Led the DM team on CART-Cell Therapy DLBCL indication pivotal trials from protocol development to submission. Kymriah® (tisagenlecleucel) was the first FDA approved CAR-T cell therapy. Worked as the leading DM on CAR-T therapy various indications including the all-indication long-term follow up trial.

  • Expert Clinical Data Manager

    Apr 2016 - Jun 2017

  • Lead Clinical Data Manager

    Feb 2014 - Mar 2016
• 

  Bayer

  Jun 2017 - Feb 2019

  Principal Clinical Data Manager

  Worked as the SDM/PDM on PD1 combination trial, immunology compound early development, and the integration of VITRAKVI® (Larotrectinib) which was the first treatment with a tumor-agnostic indication at the time of initial FDA approval, leading all DM activities for its HA data submission and required documentation.

• 

  Pfizer

  Feb 2019 - now

  • Manages multiple lightspeed and registrational Paxlovid trials and accountable for all DM deliverables.• Identifies, prioritizes, drives standards/methodology and delivery of all data capture needs for the trials across Assets.• Works with other asset-level leads across functions to align on priorities, timelines and deliverables.• Develops resource demands to accommodate acceleration of critical trials within my assets.• Acts as the key scientific and technical expert; define and drive the data management, standards, and reporting strategy. • Ensures work carried out by or on behalf of CDS is in accordance with applicable SOPs and working practices.• Serves as Subject Matter Expert for and oversees the design, documentation, testing and implementation of clinical data collection tools, both CRF and non-CRFs using an EDC system and/or other data collection systems. • Data Integrity planning and ongoing monitoring of conformance of data quality to plan over multiple assets, through the implementation of customize central data monitoring strategies using appropriate tools and analytics.• Execution of clinical study data due diligence for acquisition/in-licensing and co-development deals.• Key data management contact for regulatory inspections/audits in liaison with Pfizer’s Quality and Safety groups.• Pfizer Data Sharing & Data Tagging Initiative SME Show less

  • Director, Senior Asset Lead

    Oct 2022 - now

  • Associate Director, Asset Lead

    Mar 2020 - Oct 2022

  • Manager, Clinical Data Scientist

    Feb 2019 - Mar 2020