Study Manager Data Entry

LOUIS JEFFERSON

(Global Clinical Trial Management)

Education/ Certification/ Training

The Medical University of Ohio, Toledo, Ohio

Completed Two Academic Years 2004-2006

University of Connecticut, Hartford, CT

Medical Post-Baccalaureate Program, May 2002

University of Pittsburgh, Pittsburgh, PA

Master of Public Health, August 1993

Vice President's Scholarship/GSPH

Kent State University, Kent, Ohio

Master of Health Education, December 1991

Graduate Assistant of the Year, Teaching Fellow

Kent State University, Kent, Ohio

Bachelor of Science in Human Physiology, December 1988

Athletic Scholarship/Varsity Football Captain

Experience

EPM Scientific Sept 2021 - Present

Clinical Study Manager Phase I-II Oncology Clinical Trials

Operational Management of Phase I-II Immunological/Oncology Trials

Study start-up activities: Contract and Budget Negotiations with Oncology Collaborative Groups and Clinical Sites, Vendor selection/management, Regulatory Document Management, manage and facilitate protocol, ICF, eCRF, eCRF Guideline development and distribution.

Draft all study plans and facilitate dissemination

Study Maintenance activities: Site and subject recruitment management, management of interim analyses, review data management line listings, review monitoring visit reports, facilitate cross functional operations meetings.

Study Completion Activities – Manage Database Locks, Manage Trial Master File reconciliation, manage necessary site close out activities according to GCP/ICH guidelines.

USTechSolutions, Inc. May 2020- Sept 2021

Clinical Research Study Leader - Early Stage Clinical Trials

Operational Management of Phase I-II and Healthy Volunteer Neuroscience Trials

Study start -up activities: Contract and Budget Negotiations with Neurodegenerative Disorder Collaborative Groups and Clinical Sites, Vendor selection/management, Recruitment, Regulatory Document Management, manage and facilitate protocol development and distribution

Study Maintenance activities: Site and subject recruitment management, management of interim analyses, review data management line listings, review monitoring visit reports, facilitate cross-functional operations meetings.

AstraZeneca Pharmaceutical, Inc. (Contract) Sept 2017- Apr 2020

Clinical Study Manager Phase I-III Oncology Clinical Trials

Operational Management of Phase I-III Immunological/Oncology Trials

Study start-up activities: Contract and Budget Negotiations with Oncology Collaborative Groups and Clinical Sites, Vendor selection/management, Regulatory Document Management, manage and facilitate protocol development and distribution

Study Maintenance activities: Site and subject recruitment management, management of interim analyses, review data management line listings, review monitoring visit reports, facilitate cross functional operations meetings.

Study Completion Activities – Manage Database Locks, Manage Trial Master File reconciliation, manage necessary site close out activities according to GCP/ICH guidelines.

Therapeutic areas consist of oncology.

Provide clinical trial management for the potential partner Protagonist, Inc.

oTherapeutic Areas of Gastrointestinal and Hematology

oStudy start-up activities: Contract and Budget Negotiations with Oncology Collaborative Groups and Clinical Sites, Vendor selection/management, Regulatory Document Management, manage and facilitate protocol development and distribution

oProvide International Clinical Management Training in India

inVentiv Health., (Homebased - Contract) Dec 2015 – Aug 2017

Clinical Study Manager Phase I-III Immunological/Oncology Clinical Trials

Operational Management of Phase I-III Immunological/Oncology Trials

Study start-up activities: Contract and Budget Negotiations with Oncology Collaborative Groups and Clinical Sites, Vendor selection/management, Regulatory Document Management, manage and facilitate protocol development and distribution

Study Maintenance activities: Site and subject recruitment management, management of interim analyses, review data management line listings, review monitoring visit reports, facilitate cross functional operations meetings.

Study Completion Activities – Manage Database Locks, Manage Trial Master File reconciliation, manage necessary site close out activities according to GCP/ICH guidelines.

Therapeutic areas consist of oncology, CNS, and hematology.

Aerotek/Advance VACO Consultant - Genentech Inc., South San Francisco, CA May 2014 –Dec 2015

Clinical Study Manager Phase I-III Oncology Clinical Trials

Operational Management of Phase I-III Solid Tumor Trials

Study start-up activities: Manage Database Development with Data Managers, Contract and Budget Negotiations with Oncology Collaborative Groups and Clinical Sites, Vendor selection/management, Regulatory Document Management, manage and facilitate protocol development and distribution

Study Maintenance activities: Site and subject recruitment management, management of interim analyses, review data management line listings, review monitoring visit reports, facilitate cross functional operations meetings.

Study Completion Activities – Manage Database Locks, Manage Trial Master File reconciliation, manage necessary site close out activities according to GCP/ICH guidelines.

Therapeutic areas consist of oncology, CNS, rare diseases and hematology.

Expert Clinical Study Manager for multiple Phase I-III Oncology Clinical Trials.

Monitor Unblinded Drug Administration Records, AE and ECG Data

Manage Unblinded SAE query resolution, TMF management, and data management.

Manage Global Clinical Trials

Therapeutic areas consist of oncology

Global Management for Quintiles, Genentech and Novartis

Manage SAE query resolution, TMF management, and data management.

Manage Database Development with contacted/sponsor Data Managers.

Manage Patient Recruitment Strategies

Supervise Site Management: manage the process of identifying, selecting, initiating and closing-out investigational sites for clinical studies and ensuring adherence to applicable regulations and principles of ICH-GCP

Manage Local Clinical Trial Managers

Targacept, Winston Salem, NC April 2013- May 2014

Sr. Clinical Study Manager for Phase II Alzheimer’s Trials and Gastrointestinal Trials

Phase I-II Protocol writing and key member on the Study Design Team for Phase I and II protocol development

Manage Database Development with contracted Data Managers

Supervise Site Management: manage the process of identifying, selecting, initiating and closing-out investigational sites for clinical studies and ensuring adherence to applicable regulations and principles of ICH-GCP

Manage Patient Recruitment Strategies

Supervise conduct of Alzheimer’s Trials and Gastrointestinal protocols, including:

Vendor management, Operational management of CROs in various international locations, manage SAE query resolution, records management, fiscal management, and data management

Drug class consist of Neuro-Nicotinics

Manage Quality Assurance of Phase I protocols

J& J/Janssen Pharmaceutical Companies, L.A., CA Sept-2010 - Jun 2013

Global Study Manager for Phase II Oncology Clinical Trials

Supervise conduct of Advance Prostate Cancer protocols, including:

Vendor management, Operational management through Local Study Managers at various country locations, manage SAE query resolution, records management, fiscal management, and data management.

Manage Patient Recruitment Strategies

Manage Database Development, Maintenance and Database locks with Data Managers. Including development of Data Management Plans and implementation

Manage Local Clinical Trial Managers

Therapeutic areas consist of oncology and endocrinology.

Manage Quality Assurance of Phase I protocols.

Phase II Regenerative Medicine Clinical Trials

Manage and Monitor Clinical Sites

Operational Management of rhGDF-5 Clinical Trials

Supervise the conduct of clinical trials on the clinical site level for multiple national sites

Manage Patient Recruitment Strategies

Manage site regulatory compliance

Manage Drug Accountability

Contract and Budget management for clinical site and vendors

Prometheus Laboratories, Inc., San Diego, CA Sept 2009 – Sept-2010

Sr. Manager Phase I-II Oncology Clinical Trials

Site Monitoring including the following: identifying, selecting, initiating and closing-out investigational sites for clinical studies ensuring adherence to applicable regulations and principles of ICH-GCP

Manage Database Development with contracted Data Managers

Operational Management of Phase I-II Refractory Solid Tumor Trials

Study start-up activities: Protocol writing, CRF development, Investigator’s Brochure Summaries, Regulatory Document Management, CRO selection/management, Budget negotiations and Investigator’s meeting management.

Study Maintenance activities: site and subject recruitment management, management of interim analysis, review data management line listings, review monitoring visit reports

Manage Patient Recruitment Strategies

Study Management of Oncology Investigator Sponsored Studies Program.

Manage operations of multiple concepts submitted by national and international KOLs

Lead Cross Functional Review Meetings

Performed multiple protocol reviews for multiple therapeutic regimens for multiple tumor types

Budget negotiations

Review Data Management Line Listings for Safety

Study start-up activities: Protocol writing, CRF development, Investigator’s Brochure Summaries, Regulatory Document Management, CRO selection/management, and Investigator’s meeting management.

Close out activities and management of Clinical Study Report

Manage Cross Functional Teams to align their goals with Clinical Study Timelines

Line Management and indirect management of CRAs and CPAs

Therapeutic areas consist of oncology, CNS, and hematology.

Amgen, Inc., Thousand Oaks, CA May 2006 – August 2009

Global Clinical Research Manager Phase I-II Oncology Clinical Trials

Operational Management of Phase I-II Refractory Solid Tumor Trials

Study start-up activities: Protocol writing, CRF development, Investigator’s Brochure Summaries, Regulatory Document Management, CRO selection/management, Budget negotiations and Investigator’s meeting management.

Study Maintenance activities: site and subject recruitment management, management of interim analysis, review data management line listings, review monitoring visit reports

Clinical Study Manager Consultant Phase II-IIIB Clinical Trials

Study Management of Oncology Investigator Sponsored Studies Program.

Manage operations of multiple concepts submitted by national and international KOLs

Lead Cross Functional Review Meetings

Performed multiple protocol reviews for multiple therapeutic regimens for multiple tumor types

Budget negotiations

Review Data Management Line Listings for Safety

Study start-up activities: Protocol writing, CRF development, Investigator’s Brochure Summaries, Regulatory Document Management, CRO selection/management, and Investigator’s meeting management.

Close out activities and management of Clinical Study Report

Manage Cross Functional Teams to align their goals with Clinical Study Timelines

Line Management and indirect management of CRAs and CPAs

Therapeutic areas consist of oncology, CNS, and hematology.

Pfizer, Inc., Feb. 1999-Aug. 2005

NYC, NY and Groton, CT

Clinical Study Manager

Study Manager for Worldwide Phase III Anti-fungal Clinical Trial.

Supervise conduct of Anti-fungal protocols, including:

Preparation of SAE Reports to update AEM database, manage SAE query resolution, CRO and Contract CRA management, fiscal management, and data management.

Site Monitoring including the following: identifying, selecting, initiating and closing-out investigational sites for clinical studies ensuring adherence to applicable regulations and principles of ICH-GCP

Study budget management.

Therapeutic areas consist of infectious disease, immune/allergy, oncology, and ophthalmology.

Manage Quality Assurance of Phase I protocols.

Bayer, Inc., June 1997-Feb. 1999

West Haven, CT

Medical Research Associate

Supervise the conduct of 10 clinical sites for Anti-Infective Protocols.

Therapeutic areas consist of Upper Respiratory and Gastrointestinal.

Responsible for site evaluation, initiation, Close-out visits, Data listings, Monitoring and reviewing Audit Reports.

Project Team leader/CRO Management

Responsibilities include: Preparing progress reports for Bayer Product Development Team; Primary contact for CRO management and field staff; Oversee investigator recruitment efforts; Prepare narratives for medical research reports.

AMGEN, Inc., June 1995-June 1997

Thousand Oaks, CA

Clinical Research Associate

Supervised the conduct of clinical trials for Phase III Biotechnology protocols.

Responsible for site evaluation, initiation, Close-out visits.

Data listings, Monitoring, Planning and conducting Investigator's meetings and Audit Reports

Therapeutic areas include Nephrology, Cardiovascular disease and infectious disease.

Skills

Assessment and Evaluation

Data Collection and Analysis utilizing Remote Data Entry(RAVE, DataLabs, Coordinator Online and SiteBase Management

Interactive Voice Response Systems (IVRS)

Data Collection and Analysis utilizing statistical software packages (SAS, SPSS, BMDP)

Clinical Trial Management System (CTMS)

Quantum Business Process

Human Physiology-Pulmonary functioning test, Stress test, ECG, Phase I-III Cardiac rehabilitation, anthropometric measurement, daily vital signs.

Health Education and Research

Coordinated Health Outcomes Research for Clinical Trials

Research Coordinator-Analyzed, collected data, screened and enrolled study participants for The University of Pittsburgh's Dept. of Epidemiology and Social Work for clinical study of cardiovascular disease to determine the risk factors associated with individuals 65 and older.

Development Specialist- Developed, procured grants and implemented health education programs for public schools, universities, hospitals and community-based settings

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