Revised: **-May-****

SENIOR CLINICAL RESEARCH ASSOCIATE/

SENIOR CLINICAL SITE MANAGER

Yvonne Davis, B.S., B.A.

Midlothian, VA

Email: adzqr1@r.postjobfree.com

Telephone: 804-***-****

SUMMARY

Over 18 years of experience working in Phase 1 – IIIb Global Clinical Trials in the pharmaceutical and clinical research organization industry. EDUCATION

B.S., Biology, 1998

B.A., Psychology, 1998

University of Kean, Union, NJ

THERAPEUTIC EXPERIENCE

Autoimmune Disease: Systemic Sclerosis, Dermatomyositis Circulatory: Pulmonary Arterial Hypertension

Dermatology: Wart and Alopecia, Atopic Dermatitis

Endocrine/Metabolic: Dyslipidemia and Hyperlipidemia Fibrotic Diseases: Cystic Fibrosis

Hematology: Non-Hodgkin Lymphoma

Infectious Diseases: Human Immunodeficiency Virus

Inflammatory Disease:

Musculoskeletal: Rheumatoid Arthritis

Nervous System: Alzheimer’s

Oncology: Breast, Colon, Non-Small Cell Lung Cancer, Bladder Non-Muscle Invasive Carcinoma in Situ

(CIS)/ High-Grade Papillary Disease, Head and Neck Squamous Cell Carcinoma, Myelofibrosis Rare Disease: Autoimmune Encephalitis, Primary Antiphospholipid Syndrome, Leucine-Rich Glioma Inactivate 1 Autoimmune Encephalitis (LGI1), Myelin Oligodendrocyte Glycoprotein Antibody Associated Disease (MOG- AD)

Respiratory: Respiratory Syncytial Virus

Women’s Health: Vaginal Dryness

PROFESSIONAL EXPERIENCE

UCB, BioSciences, Inc. Raleigh, NC Senior Clinical Research Associate/Clinical Site Manager Dec 2020-Present

• Responsible for all kinds of site visits (e.g. Selection / Initiation / Monitoring / Close-out / Motivational / Support) and sites’ performance regarding set-up, conduct and data collection.

• Primary contact for sites regarding study-related issues.

• Responsible for the early engagement with Key Opinion Leaders (KOLs)/ sites / patients organizations and key contact point for these throughout the study. Revised: 30-May-2023

• Interact/train new investigators to work on UCB clinical trials.

• Attend key therapeutic trainings/meetings and/or industry trainings.

• Support CPM in management of the study, including but not limited to:

• Vendor management

• Training

• Logistics

• Selection of sites

• Maintenance of study tracking

• Oversight of eTMF

• Close cooperation with the Clinical Project Managers and members of the Clinicial Trial Teams to inform on all aspects of the clincial trial status at site.

• Ensure appropriate engagement and communication with internal stakeholders regarding site visits and related activities.

• Support the development of key study documents including, but not limited to Case Report Form

(CRFs), diaries, informed consent/participant information, the study concept and protocols/amendments including presentations and Investigator Meetings or other trial-related meetings.

• Prepare and/or review monitoring tools, e.g. monitoring manual

• Support CRO/vendor selection activities and provide input in development of contract specifications regarding monitoring activities for clinical trials.

• Review and approval of site regulatory packages

• Prepare or review responses to questions from Regulatory Authorities and IRBs/ECs.

• Contributes to updates of clincial program information, e.g., annual safety updates, Investigator’s Brochure, and on query resolution, as needed, etc. Depending on trial setting:

• Train appropriate internal and CRO personnel on trial-specific monitoring requirements.

• Track monitoring activities including review of regulatory package status, visit reports, queries (nature and frequency), and ensure timely collection of the data.

• Conduct co-monitoring visits with internal or CRO personnel to ensure quality of trial and initiate corrective actions where appropriate.

• Utilising all applicable Decentralised Clinical Trial (DCT) methods.

• Shares insights, innovation opportunities and patient needs internally to the team, through collaboration with the UCB innovation/Technology Transformation Implementation (TTI) Teams.

• Such other responsibilities and projects that the Company may assign, e.g., cooperation on SOPs.

• In collaboration with CPM/study team, ensure that the study is audit/inspection ready at all times and any resulting findings from audits/inspections are addressed appropriately and in a timely manner.

• Travel including overnight stays, possibly global, required. Corbus Pharmaceuticals, Norwood, MA Senior Clinical Research Associate Mar 2020-Dec 2020

• Perform investigator site pre-study site qualification visits including collection of site regulatory documents

• Assist with site start-up activities including site contracts and budget development/negotiation, and preparation of IRB submissions (including follow through to ensure successful outcome)

• Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e., central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites

• Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug

• Participate in/lead the Investigator/Initiation Meetings, ensuring the study staff conducting the study have received the proper materials, instructions and training to safely and accurately conduct the study in line with protocol requirements

• Assist in the development of study/program plans (i.e.., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.)

• Track the movement of laboratory samples and the resulting data, including the trans-shipment of samples to specialty laboratories, or movement of samples to sample-management storage.

• Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e. study-site webinars, newsletters or other potential creative solutions) Revised: 30-May-2023

• Monitor recruitment, data quality and patient safety while on site and remotely through EDC systems and direct site communication

• Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries

• Maintain project files including ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical-trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, all investigator and site correspondence, and schedules of payment

• Identify and complete follow-up of SAEs at study sites and assist with data listing, data coding, patient profile reviews, database lock, and site close-out activities

• Ensure appropriate and timely submission of documents to the Trial Master File Aclaris Therapeutics, Wayne, PA Regional Senior Clinical Research Associate Jan 2019-Feb-2020

• Responsible for overall site conduct and establishing important relationships with key site personnel

• Assist the in-house Aclaris clinical operations team in the day to day activities associated with managing clinical study conduct to support completion per established project team goals and objectives

• Serve as the primary contact with individual investigative sites

• Attend sponsor calls and internal team calls to stay informed of current study issues

• Perform site qualification, initiation, monitoring and close-out visits of investigational sites for the Company’s dermatology clinical trials

• Manage the progress of assigned studies by tracking patient recruitment and enrollment, CRF completion and submission, source data verification, drug accountability, data collection, and data query generation and resolution

• Assist in study set-up including but not limited to eCRF design, protocol review, informed consent development, feasibility tracking, study related operational manuals, training materials, and various study plans (e.g., visit logs, monitoring plan, etc.)

• Oversee and conduct monitoring activities, including remote monitoring in accordance with ICH/GCP guidelines

• Review and track monitoring reports

• Lead/manage assigned sites through regular contact to ensure site compliance, adequate enrollment, and understanding of study requirements

• Ensure complete and timely collection and archiving of TMF documents of assigned studies or program, including oversight and or submission of regulatory documents to the TMF and ongoing document reconciliation

• Effectively communicate with study team members and work closely with Sr. Director of Clinical Operations to address study related challenges

• Ability to multi-task and work across multiple clinical programs

• Assist in maintaining accurate and up to date study information within relevant tracking systems

• Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance

• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans

Davis Clinical Research, Midlothian VA Creator/Project Manager Oct 2018-Jan 2019

• Assisted in starting up LLC

• Filing of paperwork with the state of Virginia

• Examined and familiarized oneself with state rules and procedures

• Selected and incorporated business name and licensing

• Assisted with selection process of registered Agent

• Prepared an LLC Operating Agreement

• Filing of Organized paperwork with the State of Virginia

• Implemented and monitored clinical trial to ensure sponsor/investigator obligations are met and are compliant with applicable local requirements and FDA and ICH guidelines

• Served as the primary contact with state of Virginia Tax and County offices Revised: 30-May-2023

• Verified all paperwork and filing dates of certification ad required for the State of Virginia

Developed collaborative relationships with all vendors Chiltern, Midlothian VA Senior Clinical Research Associate III Feb 2017-Oct 2018

• Assisted in investigator study site selection and study start-up

• Implemented and monitored clinical trial to ensure sponsor/investigator obligations are met and are compliant with applicable local requirements and FDA and ICH guidelines

• Served a role model for Clinical Research Associate at Level 1 and 2

• Served as the primary contact with individual investigative sites

• Attended sponsor calls and internal team calls to stay informed of current study issues

• Performed clinical monitoring activities to ensure the quality and integrity of data, compliance with SOPs, ICH, GCP, and regulatory requirements ensuring study completion on time and within budget

• Conducted site visits to determine protocol and regulatory compliance, and prepared required documentation in source documents are in agreement with source, initiate data query resolution and confirm resolution in timely manner

• Identified site issues and initiates correction plans based on monitoring reports

• Ensured subject safety and adverse event reporting to sponsor and IRB/IEC

• Verified drug accountability logs and storage requirements

• Provided study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines

• Developed collaborative relationships with investigative sites, client company personnel and study vendors

UBC, Kansas, MO Senior Clinical Research Associate Nov 2015-Dec 2016

• Thorough knowledge and application of project specific protocol

• Completes on site monitoring in accordance with project specific timelines

• Completes travel scheduling in accordance with project specific and UBC guidelines

• Attends project team meetings, departmental meetings and monthly 1:1 with manager;

• Completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to CSS/RDS for filing in Trial Master File per UBC/Sponsor timelines

• Ensures follow-up of site issues and action items per UBC/Sponsor requirements

• Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS

• Completes Call Log or Telephone Contact Report detailing communication with sites per Sponsor requirements

• Monitors within EDC data entry if applicable and assists sites with DCF resolution

• Completes Regulatory Binder and Investigational Product reconciliation

• Maintains regular contact with assigned sites per study requirements

• Completes expense reports within UBC timelines; adheres to UBC Travel Guidelines

• Completes UBC and/or Sponsor SOP review and documentation within requested timelines

• Completes sponsor specific training and documentation within requested timelines PPD, Rahway, NJ Clinical Research Associate II Feb 2015–Nov 2015

• Assisted in investigator study site selection and study start-up

• Implemented and monitored clinical trial to ensure sponsor/investigator obligations are met and are compliant with applicable local requirements and FDA and ICH guidelines

• Served as the primary contact with individual investigative sites

• Attended sponsor calls and internal team calls to stay informed of current study issues

• Performed and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices

• Conducted site visits to determine protocol and regulatory compliance

• Prepared required documentation in source documents, initiate data query resolution and confirm resolution in timely manner

Revised: 30-May-2023

• Identified site issues and initiates correction plans based on monitoring reports

• Ensured subject safety and adverse event reporting to sponsor and IRB/IEC

• Verified drug accountability logs and storage requirements

• Provided study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines

• Developed collaborative relationships with investigative sites, client company personnel and study vendors

Bayer HealthCare, Whippany, NJ Senior Lead Data Manager Feb 2010–Feb 2015

• Served as Study Lead Data Manager within core and extended teams as directed by Study Manager and Medical Expert (StM/ME)

• Tracked and lead project-level data management activities while managing DM Teams efficiently to ensure timely delivery

• Identified issues and defining and direct resolution measures through 360 progress reports and DM metrics for timely delivery of clean database and proper escalation to management

• Provided oversight for outsourcing activities by providing input on budgetary items (e.g. RFP, vendor; costing, synergies, change orders, etc.), vendor selection and management, Contribute to risk management and communication

• Conducted CLM/CRA trainings according project and data management cleaning activities per SOPs, ICH Guidelines and GCP

Covance, Princeton, NJ Associate Project Manager & Monitoring Jan 2008–Feb 2010 Project Lead, Clinical Data Manager Feb 2006–Jan 2008 Associate Project Manager

• Assisted in the leadership of the core project team as directed by Senior Project Manager and Project Director (SPM/PD) to facilitate their ability to lead extended/complete project team

• Collected metrics for Earned Valued Analysis to measure study progress

• Provided direction on complex problems with investigative sites (travel 40-60%)

• Ensured complete and thorough study drug accountability and reconciliation

• Managed trip reports, letters, query resolutions and expenses

• Managed site TMF contents and work with sites to ensure communication requirements between site and IRB are adhered to

• Provided support and timely follow-up for the implementation of clinical protocols, data collection systems, pre-post audits, quality assurance activities, and final reports Project Lead, Clinical Data Manager

• Served as a direct lead for 2 projects and server as a supporting Lead for 2 International projects

• Ensured and implement mentoring program in DMs/CDCs/DMs/DPGs by executing role of mentor where assigned; and ensuring all members are trained effectively on ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs

• Provided oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, and project timelines and budgets

• Served as the project and client liaison including provision of project specific data management status, cycle time, and productivity metrics

Novartis, East Hanover, NJ Project Lead, Trial Data Manager Nov 2004–Feb 2006

• Served as a direct lead for 4 studies with CROs and Support Novartis DMs on 2 Studies

• Conducted internal and external EDC Training, including presentations at Investigator’s meetings

• Responsible for overseeing the CROs bids regarding data management providing study input regarding protocol budget and CRO selection

• Ensured data management activities outsourced to CROs are managed effectively, resulting in timely and high-quality database delivery

• Ensured data review is performed on an ongoing basis and inform management if not possible due to resource constraints

Revised: 30-May-2023

Bristol-Myers Squibb, Wallingford, CT Protocol Data Manager Jun 2003–Nov 2004

• Responsible for the ongoing review and cleanup of case report forms in adherence to timelines, project updates, protocol specifics, GCP’s and FDA regulations

• Reconciled central, local labs and safety issues with review of CRFs, Write/issue/update DCFs

(Queries) to site and/or CRAs

• Responsible for all data management deliverables within clinical studies including the startup activities, database maintenance, and database finalization

• Responsible for creating and writing edit checks relating to data quality; Data review of edit checks, DRG’s listings and case report

PPD, Wilmington, NC Clinical Data Manager Feb 2003–May 2003

• Responsible for the ongoing review and cleanup of case report forms in adherence to timelines, project updates, project related fiscal information and protocol specifics

• Responsible for development, training and validation activities for the tool used for data collection

• Data review of edit checks, DRG’s listings and case report PRA International, Eatontown, NJ Senior Clinical Data Manager Feb 2002–Sep 2002

• Responsible for all areas of Johnson & Johnson, Incorporated data management center and clinical operations

• Reconciled central, local labs and safety issues with review of CRFs, Write/issue/update DCFs

(Queries) to site and/or CRAs

• Responsible for all data management deliverables within clinical studies including the startup activities, database maintenance, and database finalization

Advance Biologics, Lambertville, NJ Clinical Data Manager Sep 2001–Feb 2002

• Responsible for all areas of data management for multiple projects ensuring timely deliverables set by the clinical team

• Responsible for the activities necessary for database finalization and adhering to the timelines established by clients

• Generated and maintained study documentation, status reports regarding projects and adhere to protocol in compliance with SOP’s and guidelines

Merck and Company, Rahway, NJ Clinical Data Manager Oct 2000–Sep 2001

• Responsible for development, training and validation activities for the tools used for data collection

• Generated queries into clinical database, database testing of mock data thru the usage of User Acceptance Testing (UAT) and ensured proper utilization of application, data entry concepts, systems, reports and comprehension of medical terminology

Fisher Scientific International, Fairlawn, NJ Market Research Analyst Jun 2000–Sep 2000

• Provided input on market research regarding new products, direction, and planning

• Analyzed monthly competitive products against fisher scientific benchmarks

• Developed techniques and programs to produce analysis reports on distribution in competition prices

• Interfaced with managers and other advisory service departments on results of targeted research projects

Musculosketal Transplant Foundation, Edison, NJ Graft Technician Jan 2000–Jun 2000

• Responsible for the skin graft layouts for clinical application and Osteo Condyle media preparation

• Generated daily environmental reports, specification files, and skin recovery tracking

• Complied with company safety guidelines, lab cleaning requirements, and inventory stocking

• Provided and ensured proper alliquoting, irradiation and autoclaving packaging, and freezing Revised: 30-May-2023

specimen samples

Schering Plough, Kenilworth, NJ Lab Assistant Feb 1999–Jan 2000

• Performed biochemical assays testing in support of new drug discovery and support daily laboratory functions

• Assisted in the preparation and maintenance of compound collection for robotic computer analysis

• Ensured accurate documentation of experimental results in spreadsheet and data processing files

• Supplied High Pressure Liquid Chromatography, operate genesis to create plates of solution, & aid scientist

PROFESSIONAL DEVELOPMENT

Training while employed at PPD is available upon request. Prior to PPD:

• American Management Association classes with focus on Leadership and Communication in Project Management, New York, New York Mar 2012-Dec 2014

PROFESSIONAL AFFILIATIONS

• Member of the Association of Clinical Research Professionals since 2015 COMPUTER EXPERIENCE

Windows 95-98, XP, MS Word, MS Excel, MS PowerPoint, MS Access, CTMS, EDC programs

(Medidata, RAVE, ClinTrial, Datalabs, InForm, Phase Forward) LANGUAGES

Native Tongue is English; Proficient in Spanish and Russian Revised: 30-May-2023

CLINICAL TRIAL EXPERIENCE

Autoimmune Disease: A Phase 3, Double-blind, Randomized, Placebo XXX Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of XXX in Systemic Sclerosis Circulatory: A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of XXX for Pulmonary Arterial Hypertension in patients with Coronary Artery Disease (CAD) Endocrine/Metabolic: A Phase II/III, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose- finding Study designed to identify XXX dose that improves High-Density Lipoproteins (HDL) levels Fibrotic Disease: A Multicenter, Randomized, Double-Blind, Placebo XXX Phase 2 Trial to Evaluate Efficacy and Safety of XXX in Cystic Fibrosis

Hematology: A Phase II/III, Study Label Study designed of XXX for the treatment of Cancer - Solid Tumors and B-Cell Non-Hodgkin's Lymphoma

Infectious Disease: A Phase I/II Open-Label Study to Assess the Safety and Tolerability of XXX in HIV-Infected Subjects

Musculoskeletal: A Phase II Randomized, Multicenter Trial to Assess the Safety and Efficacy of XXX in patients with severe Rheumatoid Arthritis

Nervous System: A 24-Week, Randomized, Double-blind, Double-dummy, Parallel-group, Active- controlled Study to Assess the Efficacy, Safety, and Tolerability of XXX Patch Formulation in Patients with Probable Alzheimer's Disease

Oncology: A Phase IIIB, Prospective, Interventional, Open-Label, Single-arm, Multicenter Study to provide XXX to Subjects diagnosed with Metastatic Colorectal Cancer who have failed after standard therapy

Oncology: A Phase II/III Randomized, Double-blind, Placebo-controlled Study to study XXX in patients with colorectal cancer after surgical removal of liver metastases and completion of all planned chemotherapy

Oncology: A Phase II Study of Novel Epothilone XXX in Patients with MBC Who Are Refractory to an Anthracycline, a Taxane, and Capecitabine

Oncology: An Open-label Phase IIa, Non-randomized Study of XXX in Breast Cancer Patients with Bone Dominant Disease no Longer Considered Suitable for Endocrine Therapy Oncology: A Phase III, Open-Label, Randomized Study of XXX in anti-PD-L-1 antibody in chemotherapy naïve patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer Oncology: A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of XXX in anti-PD-L-1 antibody in compared with Best Supportive Care following Adjuvant Cisplatin-Based Chemotherapy in PD-L1−Selected Patients with Completely Resected Stage IB−IIIA Non-Small Cell Lung Cancer

Oncology: A Phase III, Open-Label, Randomized Study of MPDL3280A (anti pdl1 antibody) compared with cisplatin or carboplatin pemetrexed for PD-L1selected chemotherapy naive patients with stage IV non-squamous NSCLC

Oncology: A Phase III, Open-Label, Randomized Study of MPDL3280A (anti pdl1 antibody) compared with gemcitabine + cisplatin or carboplatin for PD-L1 selected chemotherapy naïve patients with stage IV squamous NSCLC

Oncology: A Phase III, Open-Label, Randomized Study to assess long term Efficacy and Safety of XXX in patients with Myelofibrosis

Oncology: A Phase I open-label, multicenter, first in human study in participants with advanced solid tumors treated with XXX

A Phase III Bladder Cancer Study to assess the Efficacy and Safety of XXX in Non-Muscle Invasive Carcinoma in Situ (CIS)/ High-Grade Papillary Disease patients Oncology: Phase II Head and Neck Squamous Cell Carcinoma Rare Disease: A Phase II Randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics of XXX in adult study participants with leucine- rich glioma inactivated XXX autoimmune encephalitis, A randomized, double-blind, placebo- controlled, Phase 3 study evaluating the efficacy and safety of XXX in participants with myelin oligodendrocyte glycoprotein antibody-associated disease Respiratory: A Phase I/II Randomized Study with the focus of the Efficacy and Safety of XXX in the Treatment Respiratory Syncytial Virus (RSV) in infants; A Phase II, multicenter, open-label Revised: 30-May-2023

extension study to evaluate the safety AND tolerability of XXX in adult Study participants with Primary antiphospholipid syndrome

Women’s Health: A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of XXX in Patients with Moderate to Severe Vaginal Dryness, a Symptom of Vulvo- Vaginal Atrophy (VVA) due to Menopause

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