Project Manager Data

Stephan K. Owens, MS

Phone: 914-***-**** Email: ***********@*****.*** / ********@******.**.***/

Summary of Qualifications:

Experienced Data Manager and former scientist/supervisor with 10+ years of experience in both translation and basic research in both the academic and clinical setting. Expert in various computer programs and clinical databases such as: REDCap, Medidata, OnCore, VitalAxis (LIMS), Cerner, DaViD (LIS) and Electronic Document Management Systems (EDMS). Expert in protocol management/monitoring experience, coding/database study design, grant award manager, evaluation and ensuring integrity of study data and following study timelines in accordance with SOPs. Expert in budget analysis and financial reporting utilizing resources efficiently. Expert in clinical procedures and laboratory techniques. Adept at quickly learning and applying new concepts, techniques, and procedures. Extensive skills in leadership, organization, management, and communication. Project manager proven ability to organize, prioritize and assist with multiple projects. Lean Six Sigma White Belt.

Technical Skills:

Laboratory: Experience in a GLP, GCLP, cGMP, laboratory Animal handling, tissue culture, PCR/RT-PCR/single cell PCR, SDS-PAGE, Flow Cytometry, gel electrophoresis, media and reagent preparation, ELISA, ELIspot, DNA/RNA/protein extraction, isolation, and purification, Western blot, magnetic cell sorting, PBMC preparation, bacteria plating, HPLC. Neurobehavioral Research. Biohazard Waste Management. BSL-2, BSL-3, BSL-4

Clinical: Phlebotomy, EMS experience, specimen procurement, processed human cord blood samples BLS, vital stats and signs. SOP’s, safety reports. Logistics. EDMS (doc control). LIMS, LIS, and Citrix software. NEAR4KIDS

Computer: Mac OS X, Windows, FlowJo, Medidata, PowerBI MS Word/Excel/PowerPoint, GraphPad Prism, SigmaPlot, Oracle PeopleSoft Enterprise, general web skills (IE/Safari/Chrome) Adobe photoshop and Adobe Pro.

Education:

Bachelor of Science, Life Sciences-(Biology) – 2015

New York Institute of Technology, Old Westbury, NY

Master of Science, Biotechnology- (Bioinformatics)– 2020

Johns Hopkins University, Baltimore, MD

Professional Experience:

Clinical Data Manager II March 2023 to present

NIH/NCI-CCR Contractor

Bethesda, MD

Duties include:

Manage patient protocol information and review protocol. Incorporate protocol-specific guidelines into the review of clinical trial data on several projects simultaneously.

Manage protocol and trial development by working and coordinating with clinical research teams that include physicians, laboratory scientists, statisticians, research nurses, pharmacists, regulatory personnel, and support staff.

Manage clinical trial activities and communications with study team members throughout the protocol life cycle.

CRF study builder, custom functions all certified by Medidata.

Contribute to the design of the databases and forms, ensuring they meet requirements for the entry and reporting of clinical data of varying complexity.

Assist research team in managing clinical research-related data.

Supporting and conducting ODSS clinical informatics training activities, including scheduling, planning, developing technical training documentation and materials, including software code, and presenting training materials

Assist in the preparation, review, and submission of data to monitoring agencies.

Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practices, Good Clinical Data Management Practices, as well as SOPs and Working Instructions

Provide support and expertise to internal and contract support (CRO) study team members regarding trial-related questions or problems, clinical trial site oversight, regulatory documentation, and clinical data management.

Assist in the review of site evaluations, site selection decisions, implementation of trials at sites and site audits.

Identify issues that are problematic or potentially problematic and make recommendations working jointly with federal CTP Team Leads to identify resolutions.

Create workflow and project management templates that can be used for tracking key milestones or identify potential problems in critical path milestones which could delay mission critical projects.

Organize and maintain files on activities, site visit reports, and milestones from the various grants, contracts, cooperative agreements, and interagency agreements that impact the work unit.

Participate in clinical site visits, vendor audits, and other meetings with internal and external collaborators.

Performing mapping of clinical data (e.g., developing standardized ontologies for harmonizing communication about clinical information, such as diagnostics performed and their results) Ensure adherence to project and corporate standard operating procedures (SOPs), as well as Federal Regulations and ICH/GCP in maintaining data integrity and quality throughout a clinical study.

Performing landscape analysis of clinical data standards (e.g., reviewing and synthesizing the literature to identify opportunities, gaps, or trends) Compliant with IRB, ICH/GCP guidelines, federal and state regulations, and laws that govern research administration.

Works closely with PI and study team to ensure that all expenses are captured accurately in the budget.

Award Administrator October 2023 to September 2024

The Geneva Foundation

Bethesda, MD

Duties include:

Facilitates pre- and post-award programmatic and financial activities of the Grants and Contracts Department (GCD).

Oversee staffing, hiring, salary negotiations and performance review processes for program staff, under limited supervision by the Grants and Contracts Manager

• Independently oversee general administrative needs such as timesheet approval, new hire paperwork, distribution of forms, etc. for program staff

• Prepare, coordinate, and review administrative and budgetary proposal elements (i.e. biographical sketches, facilities and resources pages, budget and budget justifications, etc.)

• Prepare monthly revenue tracking and annual budget projections for review to ensure department revenue goals are achieved by the Grants and Contracts Manager

• Initiate and manage subcontract and independent contract agreements, monitoring reporting requirements and completion of deliverables

• Process AP and Travel requests for active projects, and as assigned by the Grants and Contracts Manager

• Monitor proposal status and advise PI on requirements and submission deadlines

• Certify all investigator-driven federal grant and contract submissions for the assigned team include compliance with applicable representations and certifications as well as agency style guidelines

Review and prepare written reviews of research grant applications.

Assign applications to reviewers.

Senior Clinical Laboratory Scientist Jan 2023 to Aug 2023

Exact Sciences (2nd Shift)

Baltimore, MD

Duties include:

Responsible for quality control of data in regards of compliance with regulatory requirements of various protocols and CLIA/ CAP protocols

Process improvement high complexity testing, GLP and performing developed test in in vitro.

DNA isolation, quantification, NGS, sample prep, and more

Collaborate with leadership on new laboratory initiatives.

Perform, review and document laboratory quality control procedures.

Mentor and train team members.

Participates in QA/QI initiatives as assigned.

Maintains confidentiality of data as required.

Clinical Lab Supervisor Oct 2022 to Jan 2023

Shield T3, LLC (2nd Shift)

Washington, DC

Duties include:

Ensuring environmental monitoring of lab and patient samples ensuring accuracy in patient results. Testing and monitoring contamination

Responsible for quality control of data in regards of compliance with regulatory requirements of various protocols and CLIA/ CAP protocols

Development and implementation of SOPs.

Execute training consistent with the requirement of repeatability, minimizing risk of error that could threaten patient results, lab safety or organization reputation.

Ensuring direct report comply with BLS-2 working procedures and standards.

Directly supervise, train and mentor laboratory testing staff. Clearly communicate expectations to staff and evaluate individual employee performance.

Monitor daily workflow in the lab, plan / schedule for adequate assay coverage, and troubleshoot / escalate problems, as necessary.

Build and sustain collaborative relationships with individuals in different disciplines and serve as subject-matter expert for research teams and collaborators.

In charge of training lab techs to be compliant in all areas of the lab

Use financial software and advanced Excel skills (ex. Macros, formulas, PivotTables) for analysis and formulation of actionable financial data.

Accomplishments: Leading a team of 20+ MLT/CLS combating the pandemic

Clinical Lab Supervisor Apr 2021 to Sep 2022

Opentrons Labworks, LLC/PRL (2nd/3rd Shift)

Rockville, MD

Duties include:

Ensuring environmental monitoring of lab and patient samples ensuring accuracy in patient results. Testing contamination

Responsible for quality control of data in regards of compliance with regulatory requirements of various protocols and CLIA/ CAP protocols

Monitoring clinical clients, interpreting/identifying data and ensuring results are conducted in a timely manner.

Development and implementation of SOPs.

Directly supervise, train and mentor laboratory testing staff. Clearly communicate expectations to staff and evaluate individual employee performance.

Monitor daily workflow in the lab, plan / schedule for adequate assay coverage, and troubleshoot / escalate problems, as necessary.

Clinical data curation and integration

Validating and testing new bioassays such as ELISA

Develop, input, and maintain databases, trackers, and documentation for the lab.

COVID, Influenza A/B, and RSV.

In charge of training lab techs to be compliant in all areas of the lab

Communicate regulatory and clinical operations strategy effectively with high-level scientists, physicians, managers, and administrators, as well as with consultants, and other interested parties.

Represent QA Operations in Tier meetings.

Serve as a regulatory and clinical operations subject matter expert for the VRC, including advising on the regulatory process to meet FDA requirements and international site requirements.

Provide bi-weekly or monthly cost tracking, budget analysis, formulation, execution, and monitoring for an assigned group of laboratories to create financial reports.

Act as a resource in patient care billing compliance, participating in training and education as needed.

Acts as a resource in the development of internal policies, procedures and job aides related to clinical lab billing.

Accomplishments: Leading a team of 20+ MLT/CLS combating the pandemic and contributing to CLIA and CAP accreditations.

Associate Scientist Aug 2020 to Jan 2022

NIH/NIAID – Vaccine Research Center (VRC) – Vaccine Production Program (VPP)

Gaithersburg, Maryland

Contractor: Medical Science & Computing, Inc

Duties include:

Manage and provide oversight for scientific and regulatory-supporting documentation systems for a diverse group of scientist and administrative staff.

Supports clinical staff develop, implement, and maintain clinical research data files and materials.

Assist in the development of tools and processes that will improve the effectiveness and efficiency of clinical monitoring.

Development and implementation of SOPs and bioassay development

Coordinate with multidisciplinary teams to execute clinical trials for various infectious disease studies.

Use information technology/telecommunication systems for data management and document control, support the dissemination of information on vaccine, monoclonal antibody and other.

VRC clinical trials and respond to related inquiries from sites, sponsors, FDA, and other regulatory agencies.

Support team collaborations with internal and external stakeholders, including communication of trial information, data, and shipment of biological samples.

Evaluate scientific aspects of concepts, proposals, protocols and reports for research.

Identify the administrative and the scientific issues in the grant applications or contract proposals, including the hypotheses and rationale presented in the applications/proposals.

Serve as a liaison on matters with intramural and extramural collaborators and program officials at NIAID on joint vaccine development projects.

Prepare and review regulatory submissions, annual reports, IND safety reports, human subjects experience sections for investigator brochures and other supporting documents for vaccine and other related product types.

Assist and communicate with NIAID Budget Office on budget allocation, year-end close, and spend projections Oversee coordination and systems development for transfer product administration information to clinicians for clinical trial use, as well as product quality monitoring during clinical trial duration.

Provides oversight compliance identifying/reporting any issues, findings, while ensuring no deviations from SOPs, NIH and Federal guidelines.

Follow established departmental policies, procedures, and objectives, continuous quality, improvement quality and safety, environmental and/or infection control standards.

Provide a wide range of advanced statistical expertise, guidance, and support to researchers, scientists, clinicians, and managers engaged in research studies within the NIH. Participate in the design, development, and reporting of research studies and clinical trials. Collect, analyze and interpret biological and health science data across multiple research programs. Respond to a broad range of complex statistical issues arising in a variety of clinical and biomedical research settings.

Provide monthly financial reporting to internal and external stakeholders. These stakeholders include NIAID Leadership, VRC Leadership, Principal Investigators, and Gift Fund sources.

Responsible for the development of study budgets and negotiations to external funding agencies and sponsors including industry and contract research organizations.

Strives to meet expected turnaround times for budget development and negotiation.

Accomplishments: Contributed to all VRC functions as well as founded the DEIC

Laboratory Technician/Clinical Assistant Apr 2019 – Mar 2020

Generation Next Fertility

New York, NY

Duties include:

Performed research-based data analysis on ART techniques (pregnancy outcome)

Maintained Fertility lab (Endocrinology, Hematology).

Performed daily/monthly quality control procedures for media and equipment.

Oocyte retrievals, daily plan preparation for all patients, chart rotations

Accomplishments: Helped with cleaning up their LIMS system and working on a clinical ART pregnancy outcome

Laboratory Technician Aug 2017 – Apr 2019

Columbia University, Irving Medical Center

New York, NY

Duties include:

Performed behavioral test in mouse models with neurological disorders.

Analyze and organize data, manage animal breeding for different investigators, harvest tissues.

Trained clients in animal behavioral assays who used our core facility for research.

Troubleshooted various equipment and assisted on various research protocols.

Maintained various rodent colonies in the IGM labs.

For statistically analysis used GraphPad Prism for clients also used R, Python, and various other data packages to give clients results.

Accomplishments: Collaborated with several departments within CUMC and contributed to published work.

Research Assistant Dec 2014 – Jul 2017

Feinstein Institute of Medical Research/ Western Michigan University, Homer Stryker MD School of Medicine

NY/MI

Duties include:

Performed protein extractions, western blot, PCR, and various other techniques.

PI Dr. Thomas Rothstein

Contributed to research lab operations and equipment.

Conducted experiments involving processing of human blood and cord blood to analyze lymphocytes.

Performed Elisa, Western blotting, Cell Culture, HPLC and various techniques for experimental projects and various bioassays.

Supported and assisted staff with ongoing human clinical trials, experiments, projects, inventory database and more

Serve as a member of high performing interdisciplinary research team.

Created/ modified protocols for the Center of Immunobiology

Same PI Dr. Thomas Rothstein migrated from Feinstein Institute to Michigan for new lab.

Managed lab operations and personnel

Collaborated with investigators to develop and perform experiments involving B1 cell development and function in various animal models and patient samples.

Negotiated contracts with vendors.

Performed Elisa, Western blotting, Cell Culture, and various techniques for experimental projects.

Prepare sequencing libraries for Illumina and 10x Genomics platforms.

Prepare QC RNA and DNA samples for sequencing.

Developed and tested immune-bioassays, cell-based assays (cell death, proliferations, viabilities studies)

For statistically analysis used GraphPad Prism for clients also used R, Python, and various other data packages to give clients results.

Participates in research coordinator training as needed by developing and delivering presentations at monthly meetings or quarterly orientations as needed

Accomplishments: Contributed to B1 and ribosomal protein Haploinsufficiency research. Assisted with the establishment of the first research lab within the medical school.

Research:

S. Singh, S. Owens, and T. Rothstein. Ribosomal proteins possess p53-independent tumor suppressor function Poster presentation, NIH future Research Leaders Conference, September 2015

Oral Presentation:

Mouse models of neurodevelopmental disorders. Biomedical Research Awareness Day (B.R.A.D). Columbia University Medical Center. New York. April 17, 2018.

Volunteer Experience:

Eastchester Volunteer Ambulance Corps (EMT) 2014-2016

Science Pathfinders Program (MIM), Teacher 2014-2017

White Plains Parks & Recreation (XC/Track Coach) 2014-2019

Mentoring in Medicine, Montefiore Medical Center, Mentee 2012- 2022

Weil Cornell Medicine, New York Presbyterian Hospital, PCIU 2018- 2022

NIH/NIAID-VRC DEIC Committee-Founding Co-Chair 2020- 2022

Extracurricular Activities:

Legacy K9 Haven (CEO) {Dog Trainer DMV) 2022-present

Intervarsity Christian Club NYIT (Secretary) 2011-2013

American Red Cross Club NYIT (Member) 2011-2014

Biomedical Research Society NYIT (Vice President) 2012-2014

References:

Excellent personal and professional references available upon request.

Pending Publications:

Dugger SA, Dhindsa D, Halvorsen M, Owens S, Ozuruonye E, Montero G, Sah M, Colombo S, Petri S, Yang M, Frankel W, Boland M, Goldstein D. Transcriptomic effects, and neurological phenotypes in a mouse model of HNRNPU haploinsufficiency. Society for Neuroscience (SfN) Annual Meeting. San Diego, 2018.

Amador A, Kanber A, Ozuruonye E, Owens S, Peters J, Olson H, Poduri H, Boland M, Goldstein, Traynelis SF, Yuan H, Frankel WN, Yang M. Mice with heterozygous missense mutation of Grin2a exhibit developmental delay, hyper-activity, learning deficits. Society for Neuroscience (SfN) Annual Meeting. San Diego, 2018.

Yang M, Colombo S, Ozuruonye E, Owens S, Petri S, Montero G, Michael Boland M, Frankel W, Goldstein D. Mice with a heterozygous missense mutation in Gnb1 (Gnb1K78R/+) exhibit developmental delay, hypoactivity, gait abnormality, and deficits in spatial learning. Society for Neuroscience (SfN) Annual Meeting. San Diego, 2018.

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