Clinical Trial Trials

Ellen Harris, CCRA

Vista, CA • 612-***-**** • *************@*****.*** • LinkedIn Profile

Clinical Trial Manager

Innovative, meticulous Clinical Study Manager with over two decades of proven success, high-level performance, and diverse industry expertise. Combined with a great love in seeing improvement in people’s lives and enhancements in medicine, I understand the need to conduct efficient and effective clinical studies.

Accomplished measurable results using strong interpersonal and organizational skills that provide solution-oriented outcomes.

Successful execution of clinical trials while adhering to budgetary constraints and maintaining high-quality data integrity.

Created successful teams integrating internal and external resources into effective cross-functional teams.

Established quality plans for regular review of regulatory requirements and best practices.

Areas of Expertise

Managed medical device, drug & in vitro diagnostics studies

Conducted all phases of studies (animal through post market)

Oversaw all areas of site management (selection to close out)

Managed studies in both the United States & internationally

Selected & Managed Contract Research Organization (CRO)

Vendor management including core labs and centralized services

Expertise in study related FDA/ICH regulatory compliance

Developed study plans including monitoring & data management

Led cross-functional teams including internal & external roles

Established communication tools for management & sites

Conducted regular quality assurance audits

Review & updating standard procedures to maintain compliance

Mentored & managed clinical operations staff

Effective utilization of clinical data & study management systems

Therapeutic Areas: Rare Orphan Diseases Personalized Medicine Diagnostic Testing In Vitro Diagnostic Assays RNA /DNA Mapping Electrophysiology Women Reproductive Health Otorhinolaryngology Orthopedic Narcolepsy Cataplexy Cardiovascular

Professional Overview

JenaValve Technology – Irvine, CA September 2023 – May 2024

Senior Manager, Clinical Affairs

Heart Valve/Cardiovascular and

Developed response to internal Audit findings.

oCompleted needed documentation including updating effected SOPs, Study Plans, and Quality Response.

Established and updated study plans for OUS study conducted in Germany.

oCreated DM and Monitoring Plans for getting subject in as early as possible while remaining compliant and resolving outstanding DM issues for queries and other needed responses.

Partnered with Regulatory and Quality to make updates to clinical plans and SOPs bring into compliance with new MDR requirements.

Spruce Bioscience – San Francisco, CA October 2022 – February 2023

Senior Clinical Trial Manager

PCOS/Adrenal Androgens

Operational responsibility for executing a POC Study to evaluate the efficacy of Tildacerfont in Adult Subjects with Polycystic Ovary Syndrome (PCOS) and Elevated Adrenal Androgens.

oManaged cross-functional team and CRO for the execution of study deliverables.

oPartnered with patient advocacy group to facilitate interest in the study and drive enrollment.

Abbott RDx – San Diego, CA January 2022 – October 2022

Clinical Trials Manager

IVD/Drug Testing

Oversaw ongoing clinical trials for sample collection and assay validation for assay identifying drug usage.

oMonitored compliance with protocols and determined study completion.

oVerified study close-out activities completed and final payments made.

Managed new study start-up activities.

oConducted site selection interviews for sites with appropriate patient population and drug usage.

oRecruited clinical investigators, negotiated study budget and subject sample collection parameters.

oOversaw site start-up activities, managed 3 Clinical Research Associates responsible day to day for site management activities. Prepared twenty-four sites for activation once an investigational study assay was available.

EVOFEM Bioscience – San Diego, CA

Senior Clinical Operations Manager

Women’s Health/Birth Control/STD

Operational responsibility for the execution of an IND Study To evaluate the efficacy of EVO100 vaginal gel (combination class 1 device/applicator and study drug) in the prevention of urogenital chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) infections.

oPrepared Protocol Development through Clinical Study Report in support of the IND application.

oPartnered with selected Contract Research Organization (CRO) Study Start-up Team and Evofem Regulatory and Quality groups to oversee site selection, qualifications, and collection of documentation in support of Investigational Review Board submissions, approvals, and site activation.

oVerified completion of site monitoring, validation site documentation and data; resolved queries generated by CRO teams. Ensured ongoing quality oversight by completing co-monitoring and site/CRO audits.

oDeveloped recruitment plans utilizing multiple sourcing vendors and strategies to support and encourage participation and enrollment by clinical sites. Oversaw plans for study completion and ongoing compliance requirements.

oTurned around enrollment challenges despite Covid and other roadblocks including multiple changes in clinical management.

Invivoscribe, Inc – San Diego, CA

Clinical Affairs Manager

Invitro Diagnostics/Oncology/Personalized Medicine

Managed an international clinical affairs team executing multiple clinical studies in various counties.

Supervised teams in the US and China with study hubs in Japan and Germany.

oTravelled to China to meet with potential study site to provide samples and ongoing activities for building lab in China to process assays.

Managed ongoing clinical studies (validation and bridging studies) including international studies.

oPartnered with client pharmaceutical companies using bridging studies for subject selection,

oExecuted validation studies with selected biological sample labs for the accuracy of the investigational assays.

Developed and cultivated relationships with central laboratories for ongoing assay testing needs

Oversaw clinical studies for diagnostic testing for the assay used in independent studies and companion diagnostic testing for Leukemia and Lymphoma drugs within their developmental pipeline.

Partnered with industry and study institutions to collect samples from non-companion diagnostic studies.

Served as liaison for clinical studies with pharmaceutical partners and as representative on

cross-functional product development teams.

Oversaw development of study supporting documents and SOP review and development.

Established good clinical practices for clinical study development and execution.

Johnson & Johnson Medical Devices – Irvine, CA July 2007 – June 2018

Project / Study Manager Clinical Operations (Cardiovascular & Specialty Services)

Cardiovascular/Electrophysiology/ENT

Led cross-functional study team for extended indication for persistent atrial fibrillation for the Navistar RF Catheter.

oActivities included:

Creation of regular status reports.

Site selection and budget negotiations.

Development of enrollment plan and execution including follow-up visits.

Oversight of monitoring activities.

Established data management plan and data cleaning process.

Supported continued access study for paroxysmal atrial fibrillation for the Navistar RF Catheter

oActivities included:

Site initiation and ongoing monitoring visits

Managed monitoring and data collection.

Oversaw activities with atrial rhythm tracking vendor: collection from study participants and data transfer.

Creation of status reports.

Supported extended indication study for ventricular tachycardia for the Navistar RF Catheter

oActivities included:

Site selection, start-up activities and IRB submissions.

Site initiation and ongoing monitoring visits.

Managed post market studies for treatment of persistent and paroxysmal atrial fibrillation including management of the publication committee to publish in the Journal of American Cardiology: Electrophysiology and podium presentation to the American Heart Association.

Managed close out of post-market study for eustachian tube and sinus dilation device.

Zimmer Spine – Edina, MN April 2006 – June 2007

Clinical Research Associate / Study Manager

Spine

Managed day-to-day study activities for two investigational device studies. Prepared for study closeout and database lock.

Monitored clinical investigations sponsored by Zimmer Spine.

Maintained compliance with all applicable ICH, GCP, and FDA regulations/protocols to conduct clinical investigations.

Supported clinical investigators and their staff and mentored junior clinical staff in monitoring activities and best practices.

Assisted in developing new IDE protocol and new SOPs and Work Instructions.

Uroplasty, Inc. – Minneapolis, MN July 2004 – March 2006

Clinical Research Associate

Urology/Women’s Health

Monitored clinical investigations sponsored by Uroplasty.

Maintain compliance with all applicable FDA regulations for the conduct of clinical investigations.

Developed and supported a new SOP system and reviewed and entered case report form data into databases.

Provide support to clinical investigators and their staff.

Assisted clinical affairs with document control and maintenance along with data reviews.

Maintained and controlled clinical standard operating procedures and related quality system documents, including updating/revising documents, routing documents for approval, controlling logs, and distributing/retrieving approved documents.

Orphan Medical, Inc – Minneapolis, MN January 2004 – July 2004

Clinical Data Coordinator

Neurology/Cataplexy/Narcolepsy

Reviewed, logged, and filed Case Report Forms, studied specific test data, and reviewed Site Documentation for Protocol Deviations and Exceptions.

Contacted sites regarding Protocol Deviations, Exceptions, and Missing Data.

Documented Data Management Guidelines for Current Study Based on GCDMP Guidelines and FDA Requirements

Assisted in the development of data collection tools and trained with CRAs in the Monitoring Process

Shadowing of distinct roles in the clinical team as well as those in the whole drug development cycle

Education & Certifications

Bachelor of Science Marketing Metropolitan State University, Saint Paul, MN

Clinical Research Professional Certificate Anoka Community College, Coon Rapids, MN

Professional Memberships

ACRP: Association of Clinical Research Professionals

SOCRA: Society of Clinical Research Associates

SDRAN: San Diago Regulatory Affairs Network

Contact this candidate