Clinical research professional with over 25 years of experience

Analytical, detail-oriented, clinical research professional with over 25 years of experience in Phase I-IV studies, including global trials. Background includes work in clinical operations, project management, data management and site coordination. Therapeutic experience includes Abuse Liability studies, Attention Deficit Hyperactivity Disorder (ADHD), Cardiovascular, Central Nervous System (CNS), hypothyroidism, Non-alcoholic Steatohepatitis (NASH), Non-alcoholic Fatty Liver Disease (NAFLD), Obesity, Oncology (Breast, NSCLC, NHL, neutropenia, supportive care, bone marrow transplant, oral mucositis, Colorectal), Osteoarthritis, Pain (Non-cancer, pediatric, back, and Post-herpetic Neuralgia Pain), Psychiatry (Schizophrenia) and Stroke. EDC experience includes Oracle Clinical RDC and InForm, Medidata Rave, and OmniComm Trial Master, DataLabs, BioClinical Express.

Education

MA, May 1999

Yale University, New Haven, CT, United States

Intensive Japanese, August 1995 and 1998

Middlebury College, Middlebury, VT, United States

BA, June 1990

Williams College, Williamstown, MA, United States

Junior Year Abroad, June 1989

Stockholm University, Stockholm, Sweden

Work History

Expert Clinical Operations Professional/Consultant

August 2022 – Present

Associate Director, Clinical Operations

Altimmune, Inc., Regional, United States

April 2021 – August 2022

•Lead/participate in program strategy meetings and contribute to the operational strategy of responsible program/studies.

•Responsible for the selection and oversight of external service providers, including CROs and other vendors as necessary.

•Serve as an escalation point for Clinical Trial Managers, CRAs, or other support staff

•Develops and manages clinical trial budgets, providing ongoing financial reporting

•Leads/participates in vendor/site budget negotiations and assists with Clinical Trial Agreements as necessary

•Manages responsible study(ies) within agreed timelines and budget and in accordance with internal SOP's and GCPs

•Coordinates cross functional efforts to achieve study objectives and goals.

•Identifies and communicates study issues that will impact budget, resources and timelines.

•Provides support/escalation point for study team leads as needed.

•Establishes and maintains relationships with assigned investigator sites, vendors and consultants.

•Prepares potential investigator site lists and assists with their evaluation for inclusion in the study, ensuring proper pre-qualification of clinical sites.

•Participates in the preparation, review and finalization of clinical study-related documents such as protocols, protocol amendments, Clinical Study Reports (CSRs), regulatory submissions, and other publications as required.

•Ensures documentation prepared internally or by CRO(s) is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies/programs.

•Participates in the ongoing and final review of clinical study data to ensure the data is accurate and complete, and assessment of the impact of this data to the study and program.

•Ensures Trial Master File is accurate and up to date

•Mentors more junior team members.

•Leads department initiatives and assists in the design and implementation of standardized work processes.

Senior Clinical Trial Manager, Clinical Operations

Altimmune Inc., Regional, United States

September 2020 - April 2021

•Leads in creating and managing the study project plan, including timeline, vendors, budget, and resources

•Ensures assigned study objectives are achieved by working with all stakeholders to set project priorities and milestones and resolve project conflicts from concept through final CSR

• Develops and tracks study timelines and quality metrics

• Ensures GCP and regulatory compliance is maintained through creation and management of CQP with Altimmune Quality group

• Leads in the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.

• Leads in the logistics of IP, clinical lab samples and ancillary supply shipments

• Maintains professional expertise through familiarity with therapeutic areas

• Manages, mentors, and develops direct reports, including Clinical Trial Managers

• Attends regularly scheduled cross-functional study team meetings with internal and external resources, CROs and site staff

• Leads and/or participates in CRO and other vendor selection and management

• Participates in meetings with investigative sites, key opinion leaders and consultants as needed

• Proactively identifies and resolves issues, and participates in process improvement initiatives as required

• Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants

• Manages clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations

• Reviews serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks

• Ensures the ongoing compilation and reconciliation of the Trial Master File

Senior Study Manager (Contractor)

ExecuPharm, Inc., Regional, United States

December 2019 - September 2020

•Working in an FSP model for one of ExecuPharm’s large pharmaceutical clients

•Operational point of contact for trial execution and all trial deliverables

•Manages all Headquarters (HQ) Operational Activities, including: establishes, leads and manages Clinical Trial Team (CTT), supports clinical (drug/vaccine) supplies planning

•Manages deployment and interactions with external vendors [e.g. Interactive Voice Response System (IVRS), Patient Reported Outcomes (PRO)]

•Initiates planning for Investigator meetings and protocol training

•Plans and assesses protocol ancillary supplies

•Completes trial set-up and maintains SPECTRUM

•Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT

•Initiates recruitment/retention planning & enrollment tracking

•Responsible for tracking study related details (e.g., specimens, queries)

•Oversees protocol training activities including Investigator Meetings (IM) and Clinical Research Associate (CRA) training meetings

•Ensures appropriate postings to investigative site portals

•Responsible for operational deliverables in preparation for site ready, country allocation, and achievement of recruitment targets (with input from others)

•Point of escalation for study related operational issues

•Responsible for operational details at Operational Reviews

•Responsible for creating and maintaining project schedule and collaborating with Program Lead

•Sets up and maintains Trial Master File (eTMF)

•Ensures alignment of budget with protocol needs

•Responsible for executing protocol within the budget

•Responsible for risk assessment, mitigation planning and execution

•Responsible for creating and maintaining Actions, Decisions, Issues (ADI) Logs

•Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group

•Develops study related manuals (e.g., administrative binder, lab manuals)

•Manages Emergency Unblinding (EUB) Call Center activities

•Co-authors newsletters with Clinical Scientist (CS)

•Approves contracts, invoice payments and change orders for vendors, as necessary

•Responsible for end of study reconciliation (clinical and ancillary supplies)

•Oversees all HQ close-out tasks

•Responsible for ongoing monitoring of trial activities, e.g. dashboards, tracking

•Supports CS activities as needed to achieve CTT deliverables

•Interface with External Data Coordination and Data Management

•Responsible for quality control and inspection readiness at all times

•Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training

•Adhere to EP and Client SOPs and processes

Clinical Trial Manager

Kolon TissueGene, Inc., Regional, United States

July 2016 - December 2019

•Responsible for supporting the Sr. CTM to ensure all trial deliverables are met according to timelines, budget, operational procedures and quality standards.

•Participates in the evaluation and selection of required vendors, including contract and budget negotiation and day to day management of vendor activities.

•Manages Strategic Partners (i.e. Contract Research Organizations, (CROs), Central and Core Laboratories, etc.) to ensure adherence to scope of work within timelines and budget.

•Supports the development, management and tracking of trial budget working closely with

finance partners including review of Task Orders, Change Orders, Invoice approval and

financial reconciliation for assigned study.

•Ensures the accuracy of trial information in all trial databases and tracking systems.

•Contributes to the ongoing review of clinical data, trial data analysis, reporting and

publishing.

•May participate in the organization and logistics of various oversight or Advisory Boards.

•Serves as a point of contact for managing/answering questions related to trial procedures.

•May organize and chair sub-teams within the scope of his/her delegated responsibilities

•Oversees CRO monitoring activities which includes review of site management activities,

review of monitoring reports (trip and remote) for assigned sites/projects and review of

Corrective Action Preventive Action Plans (CAPAs) including metrics tracking.

•Oversees preparation activities for GCP audits.

•Reviews and negotiates investigative site budgets and agreements and escalates issues to Sr.

CTM as needed.

•Proactively identifies potential risks to successful trial conduct including site enrollment

targets, data capture issues, and general site performance issues.

•Conducts data listing reviews to track data quality metrics.

•Supports clinical document (i.e. protocol, informed consent, clinical study report, etc.)

writing efforts

•Establish and lead internal project team meetings

•Conducts monitoring oversight visits of CRO CRAs

•Present trial status reports to management

Senior Clinical Manager

Premier Research, Regional, United States

November 2015 - April 2016

•Responsible for the successful delivery of clinical deliverables by meeting internal and external client requirements.

•Oversaw the management of investigative sites to ensure compliance with the study protocol, contract, ICH-GCP and applicable regulations and SOPs.

•Serve as the primary liaison and primary point of escalation for start-up issues, interacting with clients, vendors and other Premier functional areas.

•Worked with the PM to facilitate cross-functional team and sponsor communication for proactive, study-wide problem-solving regarding study progress and trial issues from the start-up phase of the study through study close out.

•Provided data as required for clinical performance metrics and project status; identify measures to improve metrics; and identify out of scope tasks and escalate them as required.

•Managed project scope and budget, monitor burn rates, escalate issues with potential solutions to the PM; provides the team with Time Entry Guidelines to the team.

•Contributed to Business Development activities by participating in proposals and bid defenses as needed.

•Liaised with Clinical Managers to resolve resource and performance issues.

•Led the CRAs on a project team, providing training and mentoring as needed.

•Ensured delivery of appropriate study specific training to team members.

•Participated in the creation and maintenance of clinical project documents including Clinical Management Plans, Monitoring Guidelines, Site Operation Manuals, Monitoring Visit Letter templates, other CTMS activity templates, Monitoring visit presentations and Patient Recruitment Plans.

•Served as the primary liaison for clinical monitoring issues, interacting with clients, vendors and other Premier functional areas, escalating as required.

•Assisted with forecast for staff utilization over the life of the study.

•Analyzed data to determine impact to clinical activities; identify issues and risks; identify possible solutions to resolve the issues and mitigate the risks.

•Participated in Investigator Meetings.

•Worked with Project Manager to build and foster the client relationship.

•Responsible for successfully managing clinical deliverables to ensure that the clinical and outputs are successful and provide quality and on-time delivery.

•Communicated with the clinical team providing project objectives and expectations, celebrate successes and highlight issues.

•Liaised with CRAs regarding site monitoring issues providing recommendations and suggestions for issue resolution.

Clinical Team Manager II

PRA Health Sciences, Regional, United States

July 2011 - November 2015

•In addition to the responsibilities listed under Clinical Team Manager I, the following are part of the Clinical Team Manager II role:

•Created and maintained clinical project documents, including the Clinical Site Status Reports, Project Essential Document Checklist, Investigational Product Release Checklist and CTMS activity templates.

•Directed the transition of study activities to the maintenance IHCRA team as start-up activities are completed.

•Actively promoted positive team dynamics through effective listening and communication including interactive participation in team meetings, sharing of information and proactive problem identification/solving.

•Evaluated and confirmed the selection of clinical investigative sites.

•Built and led a cohesive monitoring team on a project, providing coaching and mentoring on project specific clinical tasks, delegating tasks as required.

•Planned, oversaw and conducted initial and ongoing training to the study team on study specifics including therapeutics area training, protocol specific training, safety monitoring/reporting requirements, drug management and data management.

•Achievement: Met study enrollment goal five months early on a global Phase II NSCLC trial.

Clinical Team Manager

PRA, Charlottesville, VA, United States

May 2009 - June 2011

•Responsible for the successful delivery of clinical deliverables by meeting internal and external client requirements.

•Oversaw the management of investigative sites to ensure compliance with the study protocol, contract, ICH-GCP and applicable regulations and SOPs.

•Served as the primary liaison and primary point of escalation for start-up issues, interacting with clients, vendors and other PRA functional areas.

•Worked with the PM to facilitate cross-functional team and sponsor communication for proactive, study-wide problem-solving regarding study progress and trial issues from the start-up phase of the study through study close out.

•Provided data as required for clinical performance metrics and project status; identify measures to improve metrics; and identify out of scope tasks and escalate them as required.

•Managed project scope and budget, monitor burn rates, escalate issues with potential solutions to the PM; provides the team with Time Entry Guidelines to the team.

•Contributed to Business Development activities by participating in proposals and bid defenses as needed.

•Liaised with Clinical Operations Managers to resolve resource and performance issues.

•Led the CRAs and IHCRAs on a project team, providing training and mentoring as needed.

•Ensured delivery of appropriate study specific training to team members.

•Participated in the creation and maintenance of clinical project documents including Clinical Management Plans, Monitoring Guidelines, Site Operation Manuals, Monitoring Visit Letter templates, other CTMS activity templates, Monitoring visit presentations and Patient Recruitment Plans.

•Served as the primary liaison for clinical monitoring issues, interacting with clients, vendors and other PRA functional areas, escalating as required.

•Assisted with forecast of units and hours and generic resources for In-House CRA and CRA activities, and determine worked units and hours, analyzing forecasted and worked activities to ensure to the contract and budget.

•Analyzed data to determine impact to clinical activities; identify issues and risks; identify possible solutions to resolve the issues and mitigate the risks.

•Participated in Investigator Meetings.

•Worked with Project Manager to build and foster the client relationship.

•Responsible for successfully managing clinical deliverables to ensure that the In-House CRAs, CRAs and outputs are successful and provide quality and on-time delivery.

•Communicated with the clinical team providing project objectives and expectations, celebrate successes and highlight issues.

•Liaised with CRAs regarding site monitoring issues providing recommendations and suggestions for issue resolution.

•Achievement: Successfully led a global team of CRAs and IHCRAs in providing on-time delivery of clinical deliverables; contributed to the on-time lock of the clinical database for a global, Phase II pediatric pain trial for a Schedule II pain medication.

Lead Clinical Research Associate

PRA, Charlottesville, VA, United States

October 2007 - April 2009

•Served as the primary liaison for clinical monitoring issues; Reviewed and approved monitoring reports and ensured tracking of ongoing site issues.

•Addressed and resolved all internal and external clinical issues for client research projects managed by PRA.

•Managed investigational sites to ensure compliance with the trial protocol, ICH-GCP and applicable regulations.

•Provided data as required for clinical operations performance metrics and project status metrics.

•Created and maintained clinical project documents, including Clinical Management Plans, Site Operation Manuals, Monitoring Visit Letter templates, other CTMS activity templates and monitoring visit presentations.

•Lead a team of 5-8 CRAs on a project, provided training and mentoring as needed.

•Supervised Investigational Product accountability, subject screening/enrollment, Case Report Form (CRF) retrieval, and query distribution to/retrieval from investigative sites.

•Managed the projected hours of CRA and Lead CRA activities to ensure adherence to the contract and budget; tracked out of scope activities.

•Achievement: Successful managed the clinical portion of a Phase II, colorectal cancer trial and contributed to freezing and locking the database 1 month ahead of schedule.

Clinical Program Manager

Shire Pharmaceuticals/New River Pharmaceuticals, Blacksburg, Virginia

September 2005 - October 2007

•Contributed to the management of clinical trials which resulted in FDA approval of the first prodrug stimulant for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

•Oversaw the operational planning, execution, and evaluation of a multi-faceted clinical program consisting of a set of clinical trials in pediatric and adult populations conducted in compliance with ICH GCP and FDA regulations.

•Managed fiscal, operational, and administrative management of the program.

•Participated in vendor selection and management, serving as a point of representation for the external contractors on operational matters.

•Provided feedback to the Chief Medical Officer on draft protocols during review rounds.

•Drafted the adverse event (AE) narratives section of a Clinical Study Report (CSR), reviewed CSRs, and performed quality control checks on CSRs.

•Conducted on-site monitoring visits for Phase I and II studies. •Conducted internal GCP audits of key research sites for Phase III studies.

•Achievement: Contributed, as part of team, to the submission and successful approval of an NDA for the first prodrug stimulant to treat ADHD in children.

•Achievement: Contributed to the submission and successful approval of a Supplemental NDA for the first prodrug stimulant to treat ADHD in adults.

Senior Clinical Operations Specialist / In-house Clinical Research Associate II

PRA, Charlottesville, VA, United States

September 2003- September 2005

•Performed study tracking to ensure that the study files were current, accurate and complete.

•Managed investigational sites to ensure compliance with the trial protocols, ICH GCP, and applicable federal and state regulations.

•Managed time and project requirements based on study contract; identified out of scope activities.

•Performed essential document, collection, review and maintenance.

•Assisted with investigational product accountability, subject screening/enrollment, case report form (CRF) retrieval, and query distribution to/retrieval from investigational sites.

•Performed investigator evaluation and recruitment during study start-up.

•Provided clinical status and metrics updates to internal team and sponsor during team meetings.

•Created and maintained clinical project documents including the Clinical Management Plan, Monitoring Guidelines, Site Operations Manual, Monitoring Visit Report and Letter Templates under the guidance of the Lead CRA.

•Assisted regional clinical monitoring staff with PSSVs, IMVs, and COVs for two Phase IV and three Phase II oncology studies.

•Answered protocol-specific questions from investigate sites and CRAs for five oncology trials as part of a command center team.

•Performed investigative site evaluation and recruitment when client added additional sites to a study.

•Managed investigational sites to ensure compliance with the trial protocols, ICH GCP, and applicable federal and state regulations.

•Assisted with sending out and collecting data clarification forms (DCFs) to study sites; assisted the sites with questions regarding the DCFs.

•Worked with the Lead CRA on management of the clinical budget and evaluation of study processes.

•Communicated common site trends to the Lead CRA, sponsor, and other team members.

•Achievement: Awarded 2004 PRA President's Award for outstanding performance.

Clinical Data Manager/Consultant

Atlantic Search Group, Cary, NC, United States

March 2003 - June 2003

•Reviewed data from a type II diabetes trial to verify adherence to study protocol and ICH GCP.

•Worked on location in California for ASG's client, a mid-size CRO, as a data management consultant on a large multi-center, multi-study diabetes program.

•Tracked case report forms (CRFs), reviewed edit checks, issued data clarification forms (DCFs), updated data in the clinical databases, reconciled Serious Adverse Events (SAEs), reviewed SAS listings and performed Quality Control (QC) audits to ensure data accuracy.

Clinical Data Associate II

INC Research/DataSpectrum, Charlottesville, VA, United States

July 2001 - January 2003

•Reviewed data from Phase II and Phase III CNS, pain, and stroke studies to verify adherence to study protocol and ICH GCP.

•Tracked case report forms (CRFs), reviewed edit checks, issued data clarification forms (DCFs), updated data in the databases, reconciled Serious Adverse Events (SAEs), reviewed SAS listings and performed Quality Control (QC) audits to ensure data accuracy.

•Worked on post-operative pain study with 350 patients utilizing Oracle Clinical as the electronic data capture (EDC) system.

•Assisted the Chief Medical Writer with reviewing results from Japanese clinical trials published in Japanese.

•Promoted from Clinical Data Associate I to Clinical Data Associate II based on outstanding work.

Clinical Data Associate I

Kendle International, Old Lyme, Connecticut

May 1999 - March 2001

•Reviewed data from a global Phase III cardiovascular trial to verify adherence to study protocol and ICH GCP.

•Tracked case report forms (CRFs), reviewed edit checks, issued data clarification forms (DCFs), updated data in the database, reconciled Serious Adverse Events (SAEs) in the clinical and client-held safety databases, reviewed SAS listings and performed Quality Control (QC) audits to ensure data accuracy.

•Worked on a team of eight responsible for reviewing the data from a global cardiovascular study with over 6,000 randomized patients.

Clinical Research Coordinator

University of Virginia, Department of Cardiology, Charlottesville, VA, United States

October 1995 - June 1997

•Pre-screened and recruited subjects for two Phase III intermittent claudication trials.

•Conducted study procedures and collected data for two pharmaceutical trials, which led to FDA approval of a new drug to treat intermittent claudication.

•Administered Holter monitors and ECGs to study subjects.

Therapeutic Experience

•CNS

•ADHD

•Oncology

•Hematology

•Neurology

•Endocrinology

•Psychiatry

•Osteoarthritis

•NASH

•NAFLD

Insulin Resistance (trials: 1, phases: III)

Oral Mucositis (trials: 1, phases: IIIB)

Multiple Myeloma (trials: 2, phases: III)

Myelofibrosis (trials: 1, phases: III)

Neutropenia (trials: 5, phases: II, IV)

GvHD (trials: 1, phases: IIIB)

Chronic Pain (trials: 2, phases: I/II, III)

Traumatic brain injury (trials: 1, phases: III)

Breast Cancer (trials: 4, phases: III)

Colorectal Cancer (trials: 1, phases: II)

Multiple Solid Tumors (trials: 1, phases: IV)

NSCLC (trials: 6, phases: II, III)

ADHD (trials: 3, phases: III)

Abuse Liability (trials: 2, phases: I/II, II)

Schizophrenia (trials: 2, phase: III)

Osteoarthritis (trials: 2, phase: III)

NASH (trials: 3, phase: I)

NAFLD (trials: 1, phase: I)

Abstracts

•M. Scott Harris, Stephen Harrison, John Nestor, Sarah Browne, Jacques Payne, Staci Steele,

Robert Casper, Anvar Suyundikov, Vyjayanthi Krishnan, Scot Roberts, Joyce James. Pemvidutide (ALT 801), a novel GLP-1/Glucagon dual receptor agonist, achieves rapid and potent reductions in body weight and liver fat: Results of a placebo-controlled, double-blinded, first-in-human (FIH) clinical trial. Abstracts of The European Association for the Study of the Liver (EASL), International Congress,

22 Jun 2022.

•Samuel Klein, John Nestor, M. Scott Harris, Jacques D. Payne, Staci M. Steele, Robert Casper, Anvar Suyundikov, Vyjayanthi Krishnan, M. Scot Roberts, Sara K. Browne. Pemvidutide (ALT-801), a

balanced GLP-1/glucagon dual receptor agonist, induces rapid weight loss and improves cardiometabolic biomarkers in overweight/obese people. Abstracts of the American Diabetes Association (ADA). 82nd Scientifics Sessions, 3-7 Jun 2022.

•M. Scott Harris, John Nestor, Joyce James, Sarah K. Browne, Jacques D. Payne, Staci M. Steele, Robert Casper, Anvar Suyundikov, Vyjayanthi Krishnan, M. Scot Roberts, Stephen A. Harrison. A placebo-controlled, double-blind, first-in-human study of Pemvidutide (ALT-801), a novel GLP-1/glucagon dual receptor agonist for the treatment of NASH and obesity. Therapeutic Agents for Non-alcoholic

Steatohepatitis and Liver Fibrosis (NASH-TAG), 6-8 Jan 2022.

System Experience

Clinical Trial Management Systems: Siebel Clinical (CTMS), Spectrum (CTMS)

EDC: Oracle Clinical - RDC, Oracle InForm, DataLabs, Medidata RAVE, OmniComm Trial Master, BioClinical Express

Project Management Systems: MS Project

eTMF: Veeva Vault

Licenses, Certifications & Affiliations

•Certified Clinical Research Professional (CCRP), Society of Clinical Research Associates (SOCRA)

Contact this candidate