SHAUNA W. MANKIEWICZ
CROFTON,MD
Summary
Highly experienced Clinical Scientist and Researcher with a proven track record of 15+ years in both international and domestic health sectors. Possesses extensive expertise in clinical and project management, particularly in the field of infectious diseases. Specializations include RSV vaccine effectiveness, HIV prevention, HIV vaccines, and Ebola vaccines. Has worked across diverse settings, including industry, nonprofit organizations, CROs, academia institutions, hospital settings, reference laboratories, clinical laboratories, and research laboratories. Well-regarded for exceptional multitasking abilities, organizational skills, motivation, efficiency, passion, strategic thinking, leadership, and teamwork. Adaptable to any environment and dedicated to improving the lives and health of at-risk populations. Committed to spearheading the development of clinical and vaccine trials as the ultimate driving force.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Director, Clinical Scientist
Pfizer, Inc
06.2023 - Current
- Provided leadership in clinical epidemiological study (post-licensure) execution ensuring consistency of approach, conduct, result reporting, and oversight of core team activities within one or more vaccine asset programs (RSV, COVID-19, GBS, etc.).
- Led via a matrix organization Epidemiology, Biostatics, Clinical Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members.
- Worked with clinical operations and medical directors to develop consistent language and criteria for forms, protocols, reports and safety procedures.
- Strategically partner with Medical/Scientific Affairs to develop operating plans and study strategies in support of the Clinical Development and Life Cycle plans.
- Spearheaded protocol study design, protocol authorship, trainings, data review and interpretation, program scientific and integrity oversight, safety review and communication, regulatory document queries, clinical study reports, and publication preparation and review.
- Maintained quality, data integrity, safety, and alignment with company values.
- Contributed and provided expertise to discussions to ensure consistency and program needs.
- Reviewed medical/clinical writing, developed staff, and provided ongoing feedback.
- Facilitated short- and long-term resource planning, identified priority settings, and proactively identified resource and skill gaps to address the needs of the program(s).
- Provided expert knowledge of epidemiologic and vaccine clinical trials for operational strategic partners at the program and/or study level.
- Played a pivotal role with cross-functional team leads on epidemiologic and Phase IV (post-licensure) study planning activities (Operating Plan, Lifecycle Plan development, etc.).
- Spearheaded regulatory submissions, responses to regulatory queries, and prepared team members for program regulatory inspections and audits.
- Led strategic decision-making, governance, external consultants, KOLs, and PIs.
- Assisted with company-wide, global process improvement initiatives, and championed process enhancements and solutions for complex issues.
- Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
- Facilitated cross-functional collaboration for improved decision-making processes within the organization.
- Improved project efficiency with strategic planning, resource allocation, and time management practices.
- Proactively identified potential risks and implemented mitigation strategies to minimize negative impacts on studies and business operations.
- Leveraged professional networks and industry knowledge to strengthen client relationships.
- Spearheaded innovative approaches to resource allocation and strategic planning.
- Led clinical trial protocol development and prepared amendments.
- Worked with clinical teams on study site visits and protocol training.
- Conducted thorough literature reviews to inform experimental designs and identify knowledge gaps in the field.
- Worked with medical directors, clinical operations, biostatistics and other groups to conduct clinical reviews of study data.
- Collaborated with cross-functional teams, ensuring timely completion of clinical trials within budget constraints.
- Authored comprehensive study reports, contributing to successful regulatory submissions.
- Reduced operational risks while organizing data to forecast performance trends.
- Contributed expert knowledge as a member of multidisciplinary project teams, enhancing overall project success rates within the organization.
Senior Study Manager II
Pfizer, Inc
06.2021 - 06.2023
- Developed and provided input on study designs for Ph1, Ph2, and Ph3 clinical protocols.
- Developed protocol supporting documents (informed consent documents (ICDs), case report forms (CRFs), etc.).
- Led and coordinated the execution of assigned clinical protocols.
- Moderated complexities of all study management and clinical operations for assigned clinical protocols/trials across multiple therapeutic areas (internal medicine, infectious disease, oncology, etc.).
- Provided quality oversight to the Contract Research Organization (CRO) and multiple cross-functional teams.
- Developed and led study/protocol training, refresher trainings, and Investigator Meeting (IMs).
- Developed and authored study monitoring plans (SMPs), study training plans (STPs), data management plan (DMP), communication plans, recruitment plans, and vender oversight plans (VOPs).
- Conducted country level feasibility, reviewed pre-trial assessment (PTA) outputs, assessed and selected sites, assessed site activation plans, and selected qualified CRAs for assigned studies.
- Led study risk planning, clinical trial budget development, and timeline development.
- Developed and co-authored study specific drug supply management to study sites in the Interactive Voice Randomization System (IVRS).
- Provided study management expertise and monitoring oversight to the core study team.
- Liaised with multiple cross-functional teams through strong communication, decision making, and organizational skills.
- Collaborated with medical teams to create uniform standards for clinical data reporting.
- Developed and authored clinical study reports (CSRs).
- Minimized manual system errors with streamlined data entry process.
- Gained strong leadership skills by managing protocols from start to finish, including site readiness.
- Worked effectively in fast-paced environments.
- Paid attention to detail while completing assignments.
- Learned and adapted quickly to new technology and software applications.
- Proven ability to learn quickly and adapt to new situations.
- Adaptable and proficient in learning new concepts quickly and efficiently.
- Demonstrated a high level of initiative and creativity while tackling difficult tasks.
- Excelled in a team setting, providing support and guidance.
Senior Study Manager
Execupharm, Inc (assigned to Pfizer)
11.2019 - 06.2021
- Developed and provided input on study designs.
- Developed protocol supporting documents (informed consent documents (ICDs), case report forms (CRFs), etc.).
- Led and coordinated the execution of assigned clinical protocols.
- Moderated complexities of all study management and clinical operations for assigned clinical protocols/trials across multiple therapeutic areas (internal medicine, infectious disease, oncology, etc.).
- Provided quality oversight to the Contract Research Organization (CRO) and multiple cross-functional teams.
- Developed and led study/protocol training, refresher trainings, and Investigator Meeting (IMs).
- Developed and authored study monitoring plans (SMPs), study training plans (STPs), data management plan (DMP), communication plans, recruitment plans, and vender oversight plans (VOPs).
- Conducted country level feasibility, reviewed pre-trial assessment (PTA) outputs, assessed and selected sites, assessed site activation plans, and selected qualified CRAs for assigned studies.
- Led study risk planning, clinical trial budget development, and timeline development.
- Developed and co-authored study specific drug supply management to study sites in the Interactive Voice Randomization System (IVRS).
- Provided study management expertise and monitoring oversight to the core study team.
- Liaised with multiple cross-functional teams through strong communication, decision making, and organizational skills.
- Collaborated with medical teams to create uniform standards for clinical data reporting.
- Developed and authored clinical study reports (CSRs).
- Minimized manual system errors with streamlined data entry process.
- Gained strong leadership skills by managing protocols from start to finish, including site readiness.
- Worked effectively in fast-paced environments.
- Paid attention to detail while completing assignments.
- Learned and adapted quickly to new technology and software applications.
- Proven ability to learn quickly and adapt to new situations.
- Adaptable and proficient in learning new concepts quickly and efficiently.
- Demonstrated a high level of initiative and creativity while tackling difficult tasks.
- Excelled in a team setting, providing support and guidance.
Senior Clinical Trials Specialist
The Henry M. Jackson Foundation
06.2016 - 11.2019
- Developed, implemented, and managed clinical trial protocols for the U.S. Military HIV Research Program (MHRP).
- Led clinical operations for trial execution for non-human subjects (NHSR), minimal risk (MR), and greater than minimal risk (GTMR) protocol/studies.
- Developed study work plans, deliverables, and timelines.
- Developed and implemented case report forms (CRFs), informed consent forms (ICFs), study questionnaires, site evaluation tools, diary cards, monitoring plans, clinical study reports (CSRs), Investigational Brochures (IBs), and site-specific documents.
- Provided scientific expertise to meet all regulatory requirements set forth by the Department of Defense (DoD) Institutional Review Boards (IRB), relevant Health Authorities (HA), and relevant IRBs/Ethics Committees (ECs).
- Led oversight of site activation procedures (site qualification, site initiation, training, site readiness).
- Developed and authored supporting protocol tools (Clinical Quality Management Plans (CQMPs), Clinical Manual of Operations (MOPs), and Standard Operating Procedures (SOPs)).
- Led cross-functional teams in conjunction with programs in civilian and military research sites in East Africa and Nigeria focusing on access to care, key populations, HIV testing and counseling, test and treat, and vaccine development.
- Anticipated, identified, mitigated, and resolved problems and risks associated with study progression.
- Accountability for monitoring visits, accuracy, integrity, and performance of multiple protocols/studies.
- Accountability for reportable events (AEs, SAEs, etc.) and protocol deviation (PDs) submissions and resolutions.
- Served as the main point of contact on study progress.
- Accountability for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) and maintaining regulations.
- Planned, coordinated, and lead multiple protocol specific meetings.
HIV Subject Matter Expert, Technical Specialist
ICF International
01.2016 - 06.2016
- Served as a subject matter expert in HIV for the Department of the Army, Human Immunodeficiency Virus Vaccine (HIVV) Program Management Office.
- Developed and reviewed request for proposals (RFPs) to ensure that the most highly skilled and capable qualified candidates were considered to procure a vaccine for HIV.
- Developed Market Research Reports, which identified contractors, such as organizations (non-profit, and for-profit), networks, government-sponsored research consortia, and academic institutions to lead efficacy and immunogenicity programs.
- Developed the Quality Assurance Surveillance Plan (QASP) to identify systematic methods used to measure performance and to identify the reports required and the resources to be employed.
- Designed and developed protocol documents to define roles and responsibilities, performance objectives, methodologies used to monitor and evaluate performance, quality assurance reporting, and analyses of quality assurance monitoring results.
Clinical Trials Specialist III
The Henry M. Jackson Foundation
09.2015 - 01.2016
- Developed, implemented, and managed clinical trial protocols for the U.S. Military HIV Research Program (MHRP).
- Led clinical operations for trial execution for non-human subjects (NHSR), minimal risk (MR), and greater than minimal risk (GTMR) protocol/studies.
- Developed study work plans, deliverables, and timelines.
- Developed and implemented case report forms (CRFs), informed consent forms (ICFs), study questionnaires, site evaluation tools, diary cards, monitoring plans, clinical study reports (CSRs), Investigational Brochures (IBs), and site-specific documents.
- Provided scientific expertise to meet all regulatory requirements set forth by the Department of Defense (DoD) Institutional Review Boards (IRB), relevant Health Authorities (HA), and relevant IRBs/Ethics Committees (ECs).
- Lead oversight of site activation procedures (site qualification, site initiation, training, site readiness).
- Developed and authored supporting protocol tools (Clinical Quality Management Plans (CQMPs), Clinical Manual of Operations (MOPs), and Standard Operating Procedures (SOPs)).
- Led cross-functional teams in conjunction with programs in civilian and military research sites in East Africa and Nigeria focusing on access to care, key populations, HIV testing and counseling, test and treat, and vaccine development.
- Anticipated, identified, mitigated, and resolved problems and risks associated with study progression.
- Accountability for monitoring visits, accuracy, integrity, and performance of multiple protocols/studies.
- Accountability for reportable events (AEs, SAEs, etc.) and protocol deviation (PDs) submissions and resolutions.
- Served as the main point of contact on study progress.
- Accountability for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) and maintaining regulations.
- Planned, coordinated, and lead multiple protocol specific meetings.
International QA/QC Coordinator
The Johns Hopkins University, School of Medicine
07.2013 - 09.2015
- Head representative at JHU for the HIV Prevention Trials Network (HPTN) Laboratory Center.
- Developed and authored clinical trial concepts and protocols, grants, budgets, and standard operating procedures (SOPs).
- Led site selection processes and collaborated with cross-functional funders/teams.
- Traveled for site visits to clinics and laboratories (internationally and domestically), performed audits and ensured that site staff were competent and trained.
- Led and attended meetings, site trainings, and conferences for HPTN protocols/trials.
- Provided presentations regularly on progression of clinical protocols/trials.
- Prepared operational reports for status updates on each HPTN ongoing trial (recruitment, retention, timelines, etc.)
- Performed internal audits and oversaw quality assurance on research assays and projects.
- Led and maintained trainings for study personnel to comply within regulations and strictly follow Good Clinical Laboratory Practice (GCLP).
- Named as the lead representative for the Women at Risk committee from the HPTN Laboratory Center.
Senior Research Specialist
The Johns Hopkins University, School, HIV Prevention Trials Network, HPTN
03.2011 - 07.2013
- Analyzed variations in complex tests, experiments and procedures to produce research data.
- Monitored research data to assess accuracy, validity and integrity.
- Communicated outcomes and results of research to sponsors.
- Followed health and safety regulations while handling dangerous or toxic substances.
- Guided technical programs and administrative activities in research settings and integrated quality assurance and safety programs.
- Led management, coordination, and testing of biological samples from international and domestic sites.
- Performed anti-retroviral (ARV), sexually transmitted infections (STIs), incidence, and specialized HIV testing on various biological sample types.
- Certified trainor for sites with the Laboratory Data Management System (LDMS).
- Head of the HPTN 043 sample coordination, maintenance maintaining, and tracking of a 52,000-biological sample subset.
- Assisted with protocol development and new HPTN capsule developments.
- Assisted with biological sampling for the PEPI research trial pertaining to mother to child transmission (PMTCT) through breast milk.
Clinical Laboratory Scientist II
The Johns Hopkins Hospital
07.2009 - 03.2011
- Developed and amended standard operating procedures (SOPs).
- Oversaw shipment and reception of laboratory specimens, verifying proper safety precautions and handling methods.
- Documented test results using computerized and manual transcription methods.
- Tested specimens and blood products in accordance with IATA standard operating procedures (SOPs).
- Complied with waste disposal procedures for biological and hazardous waste.
- Led quality control diagnostic testing, documenting variances in results and blood product performance.
- Maintained strict adherence to prescribed lab safety guidelines and operational instructions.
- Performed pre-analytical, analytical and post-analytical processing procedures for HIV testing.
- Analyzed testing results based on established indicators, submitting findings to central lab database.
- Kept supplies organized and well-stocked, requesting more supplies and avoiding unnecessary testing delays.
- Followed Good Clinical Laboratory Practices (GCLP) consistently across daily activities and special products.
- Identified and traced quality control issues impacting laboratory results.
- Upheld laboratory protocols dictated by facility, governing agencies, or special project requirements.
- Troubleshot problems with equipment and recalibrated devices or brought serious concerns to supervisor for handling.
Clinical Laboratory Scientist
Associated Clinical Laboratories, ACL
07.2007 - 06.2009
- Certified trained scientist as a GC/MS Operator.
- Identified and resolved unexpected results, directing secondary testing measures or collection efforts.
- Documented test results using computerized and manual transcription methods.
- Tested specimens and blood products in accordance with standard operating procedures (SOPs).
- Performed pre-analytical, analytical and post-analytical processing procedures.
- Complied with waste disposal procedures for biological and hazardous waste.
- Oversaw shipment and reception of laboratory specimens, verifying proper safety precautions and handling methods.
- Maintained strict adherence to prescribed lab safety guidelines and operational instructions.
- Helped management optimize laboratory processes for maximum efficiency and performance.
- Identified and traced quality control issues impacting laboratory results.
- Summarized test results and activities for management via verbal updates or written reports.
- Operated wide range of laboratory equipment and instruments to complete analysis.
- Analyzed and interpreted data, accurately identifying and reporting laboratory results.
- Followed Good Laboratory Practices (GLP) consistently across daily activities and special products.
- Conducted wide range of laboratory tests and recorded results.
Student Laboratory Technician
Children’s Hospital Medical Center of Akron
05.2006 - 05.2007
- Kept laboratory supplies prepared by inventorying stock, placing orders and verifying receipt.
- Performed testing and quality control using approved laboratory procedures and instrumentation.
- Maintained consumables and glassware inventory by receiving and inventorying incoming shipments.
- Interpreted and documented results of tests into active databases and communicated results to internal customers.
- Cleaned and sterilized tools and equipment to maximize purity of specimens.
- Maintained documentation on tests performed in lab.
- Calibrated and maintained instruments to keep equipment fully operational.
- Performed routine lab and department maintenance to keep area clean and orderly.
- Stored, transported, and submitted urinalysis samples.
Education
Master of Public Health (MPH) - Epidemiology
University of New England (UNE)
Biddeford, ME2016
No Degree - Doctor of Medicine
The Johns Hopkins University, School of Medicine
Baltimore, MD2013
Prerequisite Course - Medical
Community College of Baltimore County (CCBC)
Baltimore, MD2013
Bachelor of Science - Clinical Laboratory Science
Edinboro University of Pennsylvania (EUP)
Edinboro2007
No Degree - Pre-Medicine
Coastal Carolina University (CCU)
Conway, SC2004
No Degree - College Prerequisite Courses
North Central State College (NCSC)
2003
Skills
- Team Management
- Program Management
- Clinical Operations Management
- Protocol design, development, and execution
- Patient recruitment
- Site monitoring
- Collaborate, train, and lead cross-functional teams
- Manage sites, Principal Investigators (PIs), KOLs, and CROs
- Drug development
- Standard Operating Procedures (SOP) development
- Therapeutic Areas (infectious disease, respiratory, oncology)
- Data interpretation, identify trends, and present to data monitoring committee (DMC)
- ICH and Good Clinical Practice (GCP)
- Regulatory, HLA, and IND submissions
- Excellent Communication
- Organizational Skills
- Adaptability and Flexibility
- Problem-solving aptitude
- Multitasking Abilities
- Attention to Detail
- Self Motivation
- Analytical Thinking
- Time Management
- Task Prioritization
- Multitasking Abilities
- Attention to Detail
- Self Motivation
- Analytical Thinking
Accomplishments
- Protocol development within record time for RSV Maternal Vaccine Effectiveness study at Pfizer.
- Exceeded expectations for goals and company targets since 2019 at Pfizer.
Certification
- EDGE Essentials by Harvard Leadership Development Program – Certified 2024
- CITI Training – Group 3: 2015 – Present
- MT (ASCP Program Completed) and CLS (NCA) eligible – August 2007
- American Society for Clinical Laboratory Science-Ohio – Member
- ACL Safety Committee - Member: 2007- 2009
- IATA Certified – March 2009 – 2015
- Women At Risk Committee (WAR) – Member: 2011-2015
Timeline
Director, Clinical Scientist
Pfizer, Inc
06.2023 - Current
Senior Study Manager II
Pfizer, Inc
06.2021 - 06.2023
Senior Study Manager
Execupharm, Inc (assigned to Pfizer)
11.2019 - 06.2021
Senior Clinical Trials Specialist
The Henry M. Jackson Foundation
06.2016 - 11.2019
HIV Subject Matter Expert, Technical Specialist
ICF International
01.2016 - 06.2016
Clinical Trials Specialist III
The Henry M. Jackson Foundation
09.2015 - 01.2016
International QA/QC Coordinator
The Johns Hopkins University, School of Medicine
07.2013 - 09.2015
Senior Research Specialist
The Johns Hopkins University, School, HIV Prevention Trials Network, HPTN
03.2011 - 07.2013
Clinical Laboratory Scientist II
The Johns Hopkins Hospital
07.2009 - 03.2011
Clinical Laboratory Scientist
Associated Clinical Laboratories, ACL
07.2007 - 06.2009
Student Laboratory Technician
Children’s Hospital Medical Center of Akron
05.2006 - 05.2007
Master of Public Health (MPH) - Epidemiology
University of New England (UNE)
No Degree - Doctor of Medicine
The Johns Hopkins University, School of Medicine
Prerequisite Course - Medical
Community College of Baltimore County (CCBC)
Bachelor of Science - Clinical Laboratory Science
Edinboro University of Pennsylvania (EUP)
No Degree - Pre-Medicine
Coastal Carolina University (CCU)
No Degree - College Prerequisite Courses
North Central State College (NCSC)
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