Emily Arndt
Kalamazoo,Michigan
Summary
Strategic experienced clinical leader skilled in developing, directing, and executing key activities to drive business enhancements and growth. Skilled people leader, team player, collaborator, and communicator.
Overview
25
25
years of professional experience
Work History
Sr. Manager, Advanced Evidence
Stryker
Fremont, USA
01.2022 - Current
- Implemented strategic vision for the newly formed Advanced Evidence team within the Neurovascular division.
- Develops Clinical Strategy to support regulatory, marketing, health economics, reimbursement, and device claims for the divisional product portfolio with real-world evidence.
- Develops and implements strategies to improve operational efficiency, reduce costs, and increase productivity portfolio-wide for PMCF.
- Leads project managers who execute evidence generation activities such as creating white papers, reports, and publications.
- Analyzes data, identifies trends, and develops actionable insights for key stakeholders and organizational growth.
- Designs and implements clinical initiatives to facilitate expansion in different regions and indications.
- Facilitates conversations with Key Opinion Leaders to identify clinical research support requirements in line with divisional evidence needs.
- Coordinates with internal departments to ensure successful execution of projects according to timeline and budget constraints.
- Creates detailed reports on project progress for senior management review.
- Assesses and curates fit-for-purpose, real-world datasets.
- Interim management of the Biostatistics and Programming team, 3/2024 - current.
Manager, Clinical Research Strategy
Stryker
Mahwah, USA
01.2019 - 01.2022
- Led team developing global strategic evidence roadmaps for NPI integration into product development teams
- Evaluated considerations related to health economics, marketing, and regulations for study design and implementation.
- Conducted assessment of KOL requests for grants and research-funded scientific research, aligning them with internal product strategy.
- Drove collaborative efforts between marketing, R&D, and leadership to review and assess Investigator-Initiated study (IIS) proposals through the Trauma division's Strategic Review Committee.
- Led team in developing and implementing clinical activities to sustain market clearance, expand claims, and substantiate legacy product scientific claims.
- Strategized effective post-market clinical follow-up and clinical research activity efforts (PMCF) for legacy products in relation to EU MDR.
Director of Clinical Research
Homer Stryker M.D. School of Medicine
Kalamazoo, USA
01.2015 - 01.2019
- Inaugural Divisional leader: Introduced community-based shared resource approach for clinical research across three healthcare systems.
- Designed and implemented effective SOPs that redefined organizational practices
- Oversaw administrative division, enabling clinically sponsored research projects in hospital systems.
- Transitioned 3 organizations to prioritize local community involvement and established an effective organizational framework.
- Augmented the number of enrolling clinical studies by 50%, along with a reduction in overhead expenditures and escalation in earnings.
- Negotiated and updated contracts, implemented divisional processes, and guided LEAN continuous improvement efforts to transform into a fully functional unit.
Lean Process Management Consultant
Bronson Healthcare System
Kalamazoo, USA
01.2014 - 01.2015
- Coached hospital and outpatient network leadership to adopt Lean methodologies for clinical and administrative workflows
- Applied lean methodology to enhance evidence-based practices in medical care.
- Crafted efficient process to optimize healthcare system networks by incorporating cross-functional expertise in improvement practices
- Facilitated workshops with stakeholders from various departments or divisions.
- Created detailed reports outlining findings and recommendations for senior management review.
- Collaborated with cross-functional teams to develop comprehensive action plans for implementation of new processes or systems.
Clinical Program Coordinator
Beat Childhood Cancer Consortium, Van Andel Institute
Grand Rapids, USA
01.2013 - 01.2014
- Developed investigator-initiated clinical research trials for relapsed pediatric patients who exhausted approved treatment options.
- Oversaw regulatory filings for INDs and studies through collaborations with hospital networks.
- Functioned as the central hub and sponsor contact for clinical sites globally.
- Managed and developed clinical FDA studies aimed at identifying personalized biomarker approaches for tumor response.
- Provided oversight of clinical staff and ensured compliance with program policies and procedures.
- Collaborated with management staff on strategic planning initiatives related to program growth and expansion.
CRA/ Senior CRA
Pfizer Global Clinical Research and Development
Kalamazoo, USA
01.2006 - 01.2013
- Oversaw all operational aspects of assigned clinical research studies, including site selection, budget negotiations, and study initiation.
- Developed and delivered Good Clinical Practice training programs.
- Guaranteed compliance with the study protocol by supervising external staff.
- Lead team in developing project plans and timelines to ensure successful completion of projects.
- Provided guidance on technical issues related to the project.
- Analyzed project risks to create effective management strategies.
- Monitored key milestones and deliverables, reported progress to senior management and promptly made necessary adjustments.
- Managed budget resources allocated to each stage of a project.
- Negotiated contracts with vendors or suppliers related to specific projects.
Research Technician
Northern Biomedical Research
Muskegon, USA
01.2004 - 01.2006
- Managed and executed dose escalation protocols, range-finding experiments, and acute toxicology evaluations on behalf of pharmaceutical and device companies.
- Conducted feasibility and translational studies for newly developed animal device prototypes in collaboration with sponsors.
- Developed and maintained laboratory protocols for performing experiments.
- Prepared samples for analysis, including sample filtration, centrifugation, and dilution.
- Maintained records of research activities such as experimental notes, data logs, and other documents.
Critical Care Unit Coordinator
Mercy General Hospital
Muskegon, USA
01.2003 - 01.2004
- Conducted thorough reviews of patient charts and ensured accuracy in data verification and validation.
- Ensured accurate and up-to-date documentation pertaining to patient clinical procedures and consults.
- Processed and validated EHR information pertaining to patient care and where applicable, patient study enrollment.
Summer Intern
State of Michigan, Department of Agriculture, Drug Inspection
Lansing, USA
01.2000 - 01.2002
- Managed the collection of drug samples for regulatory submission and safety testing.
- Developed data outputs for local academic researchers at MSU School of Veterinary Medicine to support contract-related interests in sample testing.
Education
DMM: Disaster Medicine and Emergency Management Master’s Certificate -
Thomas Jefferson University
Philadelphia, Pennsylvania, USA01-2022
MPA: Master of Public Administration - Healthcare
Western Michigan University
Kalamazoo, Michigan, USA01-2009
BA - Biology/English
Albion College
Albion, Michigan, USA01-2003
Skills
- Strategic Planning
- Team Leadership
- Cross-Functional Communication
- Business performance management
- Partnership Development
- Resource Allocation
- Clinical Evidence Generation
- Talent Development
- Budget Oversight
Professional Memberships
- Kalamazoo Literacy Council, Board of Directors, 01/01/16, 12/31/20
- Certified, Clinical Research Professional (CCRP), Society of Clinical Research Associates SoCRA, 01/01/08, 12/31/14
- Associate, Clinical Research Professionals (ACRP), 01/01/07, 12/31/14
- Certified Talent Novation’s Instructor, 01/01/11, 12/31/13
- Midwest Society of Quality Assurance (MWSQA), 01/01/07, 12/31/11
- Recipient, Pfizer IACUC Annual Award, 01/01/09, 12/31/09, for exceptional reduction/reuse of animals for use in lab animal research
References
References available upon request.
Timeline
Sr. Manager, Advanced Evidence
Stryker
01.2022 - Current
Manager, Clinical Research Strategy
Stryker
01.2019 - 01.2022
Director of Clinical Research
Homer Stryker M.D. School of Medicine
01.2015 - 01.2019
Lean Process Management Consultant
Bronson Healthcare System
01.2014 - 01.2015
Clinical Program Coordinator
Beat Childhood Cancer Consortium, Van Andel Institute
01.2013 - 01.2014
CRA/ Senior CRA
Pfizer Global Clinical Research and Development
01.2006 - 01.2013
Research Technician
Northern Biomedical Research
01.2004 - 01.2006
Critical Care Unit Coordinator
Mercy General Hospital
01.2003 - 01.2004
Summer Intern
State of Michigan, Department of Agriculture, Drug Inspection
01.2000 - 01.2002
DMM: Disaster Medicine and Emergency Management Master’s Certificate -
Thomas Jefferson University
MPA: Master of Public Administration - Healthcare
Western Michigan University
BA - Biology/English
Albion College
Similar Profiles
Steven LopezSteven Lopez
Onsite Specialist at StrykerOnsite Specialist at Stryker
Austin GilyardAustin Gilyard
Surgical Skills Lab Supervisor at StrykerSurgical Skills Lab Supervisor at Stryker
Jeannie KussmanJeannie Kussman
Senior Supervisor Customer Service at StrykerSenior Supervisor Customer Service at Stryker
Gianni DattolicoGianni Dattolico
Medical Device Sales Representative at StrykerMedical Device Sales Representative at Stryker
Tanya SherrodTanya Sherrod
Executive Assistant at New Genesis Inc.Executive Assistant at New Genesis Inc.