K. Ingrid Durenberger

About K. Ingrid Durenberger

Award-winning, data-driven Senior Clinical Data Manager/CDM, study lead, with over 9 years of experience in clinical research, who excels in analyzing work requests, executing electronic data capture/EDC trials in a deadline-driven environment. Strengths include: • Oncology (lymphoma CAR T cell therapy; lung cancer TIL cell therapy; breast) and vaccine (HIV) clinical trials;• Study phases I-IIb and IV, with registrational trial rigor destined for FDA submission;• Medidata Rave EDC;• CRO oversight;• DMP, CCG, DRP, DTS | RECIST | Data Standards;• FDA, ICH, GCP, GCDMP knowledge;• Strive to ensure data are collected, cleaned, analyzed, validated and reported completely, accurately and securely;• DM project management skills to facilitate the work of cross-functional teams;• My leadership using the Co-Active Leadership model, using a deeply collaborative approach that harnesses the possibility of many rather than relying on the power of one; • Team player who relishes collaborating with my study teams;• Articulate, precise communicator;• Friendly, calm, and competent persona.Measurable results include:• In collaboration with data science team, successfully implemented an in-house, automated trial participant dashboard, an agile tool to improve on traditional patient profiles;• Lead the database lock for one of my cell therapy studies, the data from which contributed to the now-approved Breyanzi cellular therapy;• Lead a working group to author and implement a guideline document for eCRFs and CRF Completion Guidelines (CCGs) design/aesthetics standards.• Designed and built the eCRFs in Rave EDC Architect for a HIV vaccine study, resulting in the study going live on time that otherwise would have fallen off timeline.• As chair of my department\'s employee relations group, I lead the authoring of a remote work policy which was then implemented organization-wide.• Women In Bio former Communications Committee chair and member of board of directors;• Recipient of the 2024 Healthcare Businesswomen\'s Association-Seattle Everest award for leadership • Washington Opportunity Scholarship program college student mentor; • Society for Clinical Data Management (SCDM) 2021 conference session chair;• SCDM Education Committee member and past Marketing Advisory Board member;Driven by a passion to help bring medicines to market that will improve and save patient\'s lives, I am also committed to promoting diversity and inclusion for all women in the life sciences and furthering the advancement and impact of women in the business of healthcare.

Experience

1. Clinical Data Management Specialist Iii

   Seattle Children's

   Jan 2025 — Present · Seattle, WA, US

   Lead Clinical Data Manager for complex early phase, single and multi-site, pediatric CAR T cell therapies against liquid and solid tumors. The data management responsibilities span from study concept development through closure, including creating data specification, database build, data maintenance, study material development, study closeout activities and vendor management. • Responsible for designing and leading the study builds in Medidata Rave for a solid tumor CAR T cell study and an LTFU study, with two more in the pipeline. • After layoffs of the entire rest of my team plus manager, I became responsible organization-wide for leading all clinical data management activities for 15 phase I CAR T cell liquid and solid tumor oncology studies, as well as Medidata Rave database administrator for my organization. I became the de facto manager for my group’s contract clinical data manager, assigning, directing, and QCing her work. I assumed responsibility for tasks and initiatives previously done by my manager and colleagues, teaching myself and reaching out to myriad resources and teams to learn tasks I had not previously been responsible for. The layoffs provided an opportunity for me to grow as a leader and a clinical data manager.

Education

• Seattle University

  BS, Biology

  1982 — 1985

• University of Washington

  MS, Environmental Health Toxicology

  1989 — 1991

• Washington State University

  Zoology

  1980 — 1982

• Seneca Polytechnic

  Clinical research field within the pharmaceutical/biomedical research industry

  2014 — 2014