Clinical Trial Program Management
Resume:
Renèe M. Schweihofer-Smith
Sr. Director- PMO
*******************@*******.***
Contact
Manheim, PA 17545
Objective
As a Senior Program Director, my primary objective is to bring more than 25 years of experience in the clinical/medical and IT arenas to support and streamline the functioning of business operations by managing staff, creating and implementing project plans, managing budgets and contracts, coordinating operations and cross- functional efforts to drive delivery of exceptional work products. Education
• 2008-Madonna
University-
Nursing/Chemistry
• 2003-University of
Michigan-
Medicine/
Psychology
• 2000-St. Clair
County
Community
College- Nursing
Key Skills
• 15 years- PMO
Program/Project
Management
• 20 years- IT
development/
design and
integration
• 8 years- Clinical
Research
Management
• 25 years- Licensed
Medical
Professional
• 15 years-
Managed
Healthcare and
Utilization
Management
Experience
MARCH 2023- CURRENT
Senior Director of Program Management Clinical Trial Network
PMO Department creation and oversite- creation of department charter, standard operating procedures and policies, workflows and training materials.
Proprietary Clinical Trial Management software design, development, implementation and integration.
Program Management Planning- timeline creation and management, budget and contract negotiation and management, regulatory and quality control oversight.
Study Start-up: Oversight for all aspects of clinical trial start up to ensure timely activation for up to 100 studies at any given time. Improved study activation timelines by over 50%. Main point of escalation for all CRO and SMO contacts.
Contract and Budget Negotiation and Management- Contract upwards of 100 million dollars
Recruitment and Retention/Enrollment Strategy Development- Management of study enrollment to deliver on projections across 15+ clinical trial sites. IRB processes, regulatory document completion and submission (1572, DOA…etc)
Data Analysis, Reporting and C-suite level reporting development
Utilization of Veeva, Firecrest, Greenphire, ComTrak, Florence, Clario, G- Suite, Power BI, KanBan, Monday, Lucid, Vizio, Longboat, Workforce, Neostone, Lucid
APRIL 2022 – MARCH 2023
Senior Manager- Clinical Research Coordinators CareAccess
Oversight of 40+ clinical trial sites and associated clinical research coordinator team- decentralized trials.
CRO main point of contact- data analysis, reporting and C-suite level reporting.
Risk Benefit Analysis- risk identification and mitigation plan development
• 8 years- HEDIS
• 20 years- CMS
(Medicare/
Medicaid)
• 20 years-
Operations and
Process
Management
• 20 years- Quality
Control
Management
• 15 years- Contract
and Budget
Negotiation and
Management
• 8 years- Creating
and Consulting for
PMOs
• 15 years- Risk
Mitigation
Strategies
• 5 years- Marketing
and Meta
• 18 years-
Education
Development
• 10 years-
Utilization
Management
Guideline Creation
• 15 years- ICD
coding (ICD9 and
ICD10)
• 25 years- CPT/
HCPCS coding
Clinical Trial Management- ensuring protocols were followed, identification of issues related to site and participant management, enrollment allocation/goal management over lifecycle of trial, oversite for all sites and staff assigned.
Utilization of MS Office, Power BI, Veeva, FireCrest, Greenphire, Clinical Ink and Clario, KanBan, Lucid, Vizio, Workforce
MAY 2022-NOVEMBER 2022
Marketing Program Manager 83Bar
Marketing Plan Development and Delivery- utilization of marketing strategy to deliver on client contracts within budget and scope for various clinical trials on various Meta platforms (Facebook and Instagram).
Data Analysis, Reporting and C-suite level reporting to internal and external stakeholders.
Budget negotiation
Project Plan Creation and Timeline Management
Quality Management and IRB submission preparation and oversight
Utilization of MS Office, Meta, Power BI, PPT, Monday, Salesforce, Asana, Ironclad, Trello
NOVEMBER 2021-APRIL 2022
Clinical Program Manager Netvision Resources
Government Contractor for the Department of Veterans Affairs and Department of Defense
Program Management Planning- timeline creation and management, budget management, IRB submissions, regulatory affairs monitoring and quality control oversight.
Implementation and Integration of the Cerner Platform (EHR/EMR)
Utilization of MS Office, Power BI, PPT, Monday, SmartSheet MAY 2021-OCTOBER 2021
Clinical Program Manager Innovatech
Private Contractor- Program Management Planning- timeline creation and management, budget management, quality control oversite
Implementation and Integration of multiple platforms- myUnity, Point Click Connect, Tiger Connect, Order Connect
Utilization of MS Office, Power BI, PPT, SmartSheet, EPIC JANUARY 2020-MAY 2021
Senior Health Care Center and Clinical Trial Site Manager St. Hope Foundation
Direct management of 5 Medical and Clinical Trial Sites
Program Management Planning- timeline creation and management, budget management, regulatory oversight and quality control
HEDIS
Site Staffing and Budget Management
Laboratory Process Oversight- Including specimen collection, processing and result review with physician of record.
Grant Application Submissions
Non-profit Management
Utilization of MS Office, Power BI, KanBan, SmartSheets, CADMIUMS, Epic, Asana, Gatekeeper
FEBERUARY 2012-JANUARY 2020
Senior Director of Clinical Services Research and Development HealthHelp
Direct Management of 150+ clinical utilization management programs at any given time to include but not limited to- Cardiology, Oncology, Orthopedic Surgery, Neurology, Diagnostic Imaging, Sleep Health, and Immunology
Authoring of proprietary medical necessity guidelines with the direction of specialty Medical Directors to determine the appropriate utilization in both the private and CMS sectors.
CPT, HCPCS and ICD-10 coding standards application, oversight of billing and coding consulting team
Co-authored clinical guidelines for, partnered on contract negotiation with and assisted in sales of as well as acted as subject matter expert for clients in both the private and government sectors on all things pertaining to products and services available from the organization.
Direct Sales and Subject Matter Expert for the organization on all product offerings.
Contract Negotiation of accounts in excess of 150 million dollars.
Development, implementation and integration of proprietary guideline management software platform for both private sector and CMS clients.
Direct management of both domestic and international medical staff.
Utilization of MS Office, MS Project, Power BI, Vizio, Lucid, Workforce FEBERUARY 2012-JANUARY 2018
Program Manager- Clinical Guidelines HealthHelp
Project Plan Creation and Management- Oversight of timeline, budget, cross functional team deliverables
Oversight and administration of Physician Advisory Committee activities.
Department Creation- Education and Training: developed a fully functional, international training program for internal staff and external customers. Including but not limited to creation of standard operating procedures, workflows, policies, training materials and cadence for initial as well as periodic training programs.
Traveled internationally to set up and educate offshore resources.
Utilization of MS Office, MS Project, Power BI, Vizio, Lucid, Workforce. Additional Employment History Available Upon Request Software and Programing Language Experience
MS Office- Expert Level SmartSheets- Expert Level Asana- Expert Level G- Suite- Expert Level MS Project- Expert Level Ironclad- Expert Level Monday- Expert Level Trello- Expert Level Gatekeeper- Expert Level Kan Ban- Expert Level Wrike- Expert Level Epic- Expert Level Cerner- Expert Level TigerDirect- Expert Level Meta- Expert Level myUnity- Expert Level Point Click Care (PCC) -
Expert Level
Order Connect- Expert
Level
CADMIUS- Expert Level Praxis Fusion- Advanced
Level
Milliman Criteria- Expert
Level
Optum- Expert Level InterQual- Expert Level JavaScript- Advanced Level
Python-Advanced Level Ruby- Advanced Level HTML- Advanced Level CSS- Advanced Level SaaS- Advanced Level Salesforce- Advanced Level
Zoom- Expert Level Slack- Expert Level Veeva- Expert Level Firecrest- Expert Level Greenphire- Expert Level Florence- Expert Level Clario- Expert Level ComTrak- Expert Level Power BI- Expert Level Vizio- Expert Level Lucid- Expert Level Longboat- Expert Level NeoStone- Expert Level Workforce- Expert Level
Certification and Licensure
GCP Certification: current
Licensed Professional Nurse: 2000- current
References
Available upon request.
Clinical Trial Experience- Snapshot of Managed Studies over the Past 3 years (not all inclusive)
Alzheimer’s Disease
Phase 3
Meningococcal
Vaccine
Phase 1/2
COVID-19
Phase 2
Focal Seizures Phase 2/3 Influenza Phase 3 Acute Gastritis Phase 3
Rheumatoid Arthritis
Phase 3
Psoriatic Arthritis
Phase 2
Polymyalgia Rheumatica
Phase 2
Chikungunya Virus
Vaccine-Phase 3
Influenza Phase 3 Migraine
Phase 2
Pneumococcal Vaccine
Phase 2
Asthma Phase 2 Gout Phase 3
Epstein Barr Virus Phase
1/2
Cytomegalovirus
Phase 3
Wearable Digital Sensor Device
COVID-19 and Influenza
Phase 3
Psoriatic Arthritis
Phase 3
CardioVascular Disease
Phase 3
Type II Diabetes Mellitus
Phase 2
Respiratory
Syncytial Virus
Phase 3
Treatment Resistant Depression
Phase 2
Rheumatoid Arthritis
Phase 3/4
Type II Diabetes
Mellitus Phase 3
Varicella Phase 3
COVID 19 and Influenza
Phase 2
Clostridioides
difficile adjuvanted
vaccine Phase 1/2
Respiratory
Syncytial Virus-
Phase 1/2
Vaginal STD prevention
gel Phase 3
COVID 19/Flu
Vaccine Phase 1/2
Hypertension Phase 2
Hypertension Phase 3 Celiac Disease
Phase 2
Transdermal Contraceptive Device
Phase 3
Respiratory Syncytial
Virus Phase 1
Herpes Zoster
Phase 1/2
Osteoarthritis- Knee- Implant
Respiratory Syncytial
Virus Phase 1/2
Herpes Zoster
Vaccine Phase 2
Migraine Prevention
Phase 4
Systemic Lupus
Erythematosus Phase 2
Asthma Phase 3 Rheumatoid Arthritis
Phase 2
Sjogren’s Syndrome
Phase 3
SARS-CoV-2
Vaccine Phase 1/2
Respiratory Testing for Flu and
SARS-CoV-2 Device
Chronic Obstructive
Pulmonary Disease Phase
3
Major Depressive
Disorder Phase 3
Obesity Phase 4
Spinal Cord Stimulation
Device
Polymyalgia
Rheumatica Phase
3
Psoriatic Arthritis Phase 3
Systemic Lupus
Erythematosus Phase 1
Psoriatic Arthritis
Phase 2
Bipolar Disorder Phase 2
Psoriatic Arthritis Phase 4 Pediatric Obesity
Phase 3
Over the Counter STD
testing Device
Malignant Melanoma
Phase 3
HR+, HER2 Breast
Cancer Phase 2
Unifocal Prostate Cancer
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