CHRISTINE TURNER
ERIE,PA
Summary
- Results-driven clinical research project manager with over 10 years of experience in leading cross-functional teams through all phases of clinical study execution, from study start-up, execution, and close-out. Proven ability to lead cross-functional teams and coordinate clinical operations, medical, regulatory, data management, pharmacovigilance/pharmacodynamics, cardiodynamics, laboratory, bioanalytical, and vendor management. Proven track record of managing complex timelines, budgets, deliverables, and risks while ensuring adherence to FDA, MHRA, ICH, and GxP standards. Strong track record of delivering studies on time, resolving operational issues, and building effective relationships with sponsors, investigators, vendors and internal stakeholders. Strong analytical and organizational skills contribute to timely study delivery and effective stakeholder relationships.
Overview
30
30
years of professional experience
Work History
Global Product Manager II
Celerion
Lincoln, Nebraska (remote)
02.2021 - Current
- Lead and manage 15 or more Phase I studies, with a study team consisting of 5 to 40 or more team members, being the main point of contact between sponsors and internal operational teams, beginning at study award, start-up, execution, and through close-out.
- Responsible for managing projects' scope, timelines, and budgets, ranging from $2M to $25M per study.
- Manage and track risks and issues during studies, escalating issues when necessary, and providing regular communication to the sponsor and internal leadership until resolved.
- Monitor project and financial statuses of each project by keeping project management database systems updated weekly, so management and sponsors have access to accurate information on the progress of the study and financial performance.
- Ensure all study documentation is complete, current, and filed in accordance with the eTMF Plan to maintain continuous inspection readiness.
- Completion of phase I healthy volunteer studies is on schedule and under budget more than 90% of the time, while ensuring sponsor satisfaction from the beginning to the end of each study.
Research Project Manager
South Texas Blood & Tissue Center
San Antonio, Texas
10.2013 - 02.2021
- Grow research opportunities with large biopharma organizations.
- Manage green belt projects to improve process efficiencies, reduce process costs while maintaining quality of products to meet customer demands.
- Manage multiple cross-functional projects within the South Texas Blood and Tissue Center.
- Support QA with conducting audits - internal and/or external.
Manager Customer Support
CytoPherx, Inc
Ann Arbor, Michigan
08.2009 - 02.2013
- RABQSA ISO 13485 lead auditor certification.
- Developed internal and external auditing program/schedule.
- Conducted supplier audits, QSR audits, GCP, GMP, and GLP audits.
- Worked with clinical sites preparing for FDA inspections prior to PMA submission for study device, writing SOPs and forms for the quality systems.
- Audited selected clinical sites for GCP compliance.
- Data management of central laboratory testing of biomarkers collected during device pivotal trial sites.
- Inventory management of study devices and clinical supplies.
- Monitored clinical sites for research studies.
Product Manager
Progenika, Inc
Cambridge, Massachusetts
09.2008 - 10.2009
- Developed sales models for CLIA service testing and future product placements in clinical labs.
- Prepared documentation for pre-IDE meeting with FDA to discuss field trial expectations for blood group genotyping.
- Defined laboratory processes for molecular testing in CLIA lab in Cambridge, implementing 'sample in to results out' model.
Manager of Customer Support
BioArrays Solutions
Warren, New Jersey
06.2007 - 09.2008
- Managed projects of new genetic testing.
- Managed support staff of 8.
- Worked closely with QA department - managed CAPA systems, performed root cause analysis, ensuring defined expectations were met with customer complaint follow-ups and closures.
- Decreased start-up time of customer usage of DNA assays from average of 12 months to 6-8 weeks.
Senior Implementation Consultant
Gambro BCT
Lakewood, Colorado
01.2000 - 06.2007
- Assisted Sales with growing NE territory from $4M to $8M.
- Project management and implementation of new blood loss tracking software at multiple regions within NE territory.
- Created project plans, task/timelines, staff training schedules, and computer software validation and testing.
Director of Apheresis
American Red Cross
07.2006 - 01.2007
- Director of multiple departments - quality control, lab, tele-recruitment, manufacturing, distribution, and whole blood recruitment - ensuring timely collection, processing and distribution of blood products.
Field Applications Specialist and Sales Consultant
ChromaVision, Inc
San Juan Capistrano, California
01.1999 - 01.2000
- Provided direction for clinical trial with customers participating in Phase I, II, IIb trials.
Senior Technical Applications Specialist and Sales Consultant
CellPro, Inc
Bothell, Washington
01.1997 - 01.1999
- Managed customers throughout Phase I, II, and III clinical trials, ensuring compliance with FDA, ICH, GCP regulations.
Education
Master of Science - Clinical Research Management
Arizona State University
Tempe, AZ08-2021
MBA - Project Management
Wayland Baptist University
San Antonio, TX05-2019
Bachelor of Science - Medical Technology
Edinboro University of Pennsylvania
Edinboro, PA08-1987
Skills
- Phase I Clinical Trials, including FIH, SAD/MAD, ADME, FE, BA/BE, DDI, QT/QTC, Renal/Hepatic studies
- Study Start-up & Site Activation
- Risk and Issue Management
- Study Timelines & Milestones
- Resource Management
- Regulatory & GxP Compliance
- Clinical Data Review & Cleaning
- Safety / Pharmacovigilance Coordination
- Budget, Scope, & Change Management
- Clinical Trial Documentation
- TMF / Inspection Readiness
- Executive & Sponsor Communication
Timeline
Global Product Manager II
Celerion
02.2021 - Current
Research Project Manager
South Texas Blood & Tissue Center
10.2013 - 02.2021
Manager Customer Support
CytoPherx, Inc
08.2009 - 02.2013
Product Manager
Progenika, Inc
09.2008 - 10.2009
Manager of Customer Support
BioArrays Solutions
06.2007 - 09.2008
Director of Apheresis
American Red Cross
07.2006 - 01.2007
Senior Implementation Consultant
Gambro BCT
01.2000 - 06.2007
Field Applications Specialist and Sales Consultant
ChromaVision, Inc
01.1999 - 01.2000
Senior Technical Applications Specialist and Sales Consultant
CellPro, Inc
01.1997 - 01.1999
Master of Science - Clinical Research Management
Arizona State University
MBA - Project Management
Wayland Baptist University
Bachelor of Science - Medical Technology
Edinboro University of Pennsylvania