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Project Management Port Saint

Location:
Port Saint Lucie, FL, 34953
Salary:
112000
Posted:
December 04, 2023

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Resume:

Natalie A. Jones-Bazangoula

Address: **** ** ******** ******, **** Saint Lucie, FL34987

Phone: 305-***-****.

E-mail: ad1oz8@r.postjobfree.com

EDUCATION/CERTIFICATION/AWARDS

●BS Chemistry: Salem State University. Salem, Massachusetts (2001).

●Certified Nursing Assistant (1996).

●Magna Cum Laud: Salem State University. Salem, Massachusetts (2001).

●Who’s Who/American Colleges & Universities: Salem State University. Salem, Massachusetts (2001).

●Chemistry Department’s Highest GPA Honor: Salem State University. Salem, Massachusetts (2001).

AREAS OF EXPERTISE

●Pharmaceutical Clinical Trial processes.

●CRO Budget & Proposal Coordination in Clinical Multi-settings.

●Clinical Trial Informatics (phases I, II & III).

●Medical device industries.

●Budget Audit (polyvalent retrospective diagnoses and forecasted prognoses).

●Project Management.

●Multi-Sets Scientific Data Analysis.

●Scientific Research in Epidemiology, Real World Evidence, Systematic Literature Reviews, FDA regulatory matters, Meta-Analysis.

●Writing (Proposals, Protocols, grants and Reports).

●Coding Algorithms (ICD-9, ICD-10, Read/OXMIS codes), SAS, Ingenix Encoder Pro.

●Software: SalesForce, Maconomy, SmartSheet, VeevaVault, ClinQuick, Microsoft Visio, SharePoint, PMP standards, MS-Project Schedule, E-builder, Microsoft Office, SpotFire.

LANGUAGES

●Academic level fluency and native: English and French.

●Basic: Spanish, Kikongo, Lingala.

SELECTED KEY QUALITIES

●Excellent written and oral communication skills.

●High level of organization, multi-tasking and good time management skills.

●Extensive knowledge and experience working across international business cultures.

●Flexible, dependable, punctual, critical thinker, self-starter, results-oriented, high-level attention to details.

WORK EXPERIENCE

Succinct outline of my work history:

I have a polyvalent professional background (over a decade of cross sectional clinical trial knowledge working crossly with clinical trial subject matter experts, managing pharmaceutical companies’ request for proposals or RFPs, multivalent scientific research, scientific writing, clinical trial budgeting/auditing, general project management, college tutoring, etc.).

As a student at Salem State University, I worked in the chemistry lab performing a myriad of scientific research tasks as well as tutoring fellow students who needed help.

After obtaining my bachelor’s degree in Chemistry (in Massachusetts), I volunteered to go to the country of Jamaica to work for the impoverished and disfranchised Jamaican communities whose reclusive rural agricultural lands were plagued with heavy metals such as lead, cadmium, aluminum from decades of industrial mining by multi-national corporations – resulting in devastating scourge of metabolic, hepatic and cardiovascular diseases.

I applied and obtained a job at the International Center for Environmental and Nuclear Sciences (ICENS) where I would play a pivotal role in analyzing levels of the aforementioned heavy metals in rural soils and in foods that emanated from those rural lands. I also did post-mortem analyses of heavy metals in bodies of deceased rural people. At the end of my one year contract, I helped write tangible recommendations to the Jamaican government insofar as amending environmental regulations pertaining to corporate mining and other causalities that contributed to decades of soil pollution in the reclusive rural communities of Jamaica.

After my volunteer work in Jamaica, I came back to the US to work in the arena of Contract Research Organizations (CRO), providing clinical trial services for pharmaceutical and biotechnological companies as well as medical device industries. I have a combined 18 years of core professional experience working for two (2) CROs. My duties related to CRO work included:

Overseeing and ascertaining the qualitative work of pharmaceutical clients’ opportunities/projects from their initial phase of the Request for Proposal (RFP) to the final phase of their submission.

Working closely with subject matter experts across departments of CROs.

Capturing all projected expense metrics to build forecasted budgets in order to evaluate profits and feasibility of a given opportunity.

Working with clients from medical device industries to help research relevant information from hospitals and research health centers as well as helping to forecast financial metrics and functional feasibilities of the proposed medical devices.

Doing Meta-Analysis and Literature Reviews (including, but not limited to, Epidemiology).

Doing Real World Evidence database analysis.

Doing Project Management and other supportive administrative duties.

Extracting data from scientific papers written in French and translating them to English.

Below is a detailed version of my work history:

Celerion - Translational Medicine: Lincoln, Nebraska (2017-2023)

Budget and Proposal Coordinator (2017-2023):

●Leading the process of development of proposals from RFQ/RFP to finalization in time.

●Leading triage calls between the medical monitoring director, business development departments (BDs), subject matter experts of various departments, clinical project managers (CPMs), clinical research associates (CRAs), database managers, internal clinic, legal and contract management department and assigned external vendors.

●Liaising with subject matter experts (on study design, therapeutic area, clinical endpoints, data management, etc.) to define the scope-of-work.

●Coordinating and managing initial study feasibility through triage conference calls with internal departments to delineate study designs, preliminary clinical timelines and other study exigencies as basis for costs proposal preparation.

●Conducted retrospective study budget audits on a quarterly basis.

●Creating dynamic and functional templates to track triage call and handover meeting minutes across internal departments involved in the development of proposals.

●Coordinating with vendors and contractors to obtain pre-award site budgets/investigator grants.

●Generating CRO budget and document assumptions based on all the meta-data assembled during the costs proposal preparation.

●Working with clinical operations team to conduct peer-reviews on proposal budgets that I built, proposal languages in budget documents and scope-of-work.

●Updating financial systems and tracking RFQ information.

●Cooperating with Human Resources, Quality Assurance, Finance and Contract Management and other internal departments.

●Assisting Contract Management department in resolving issues relating to contract negotiation or management.

●Managing existing vendors’ contractual compliances and change orders in cooperation with the Clinical Project Manager (CPM).

●Negotiating change order costs of moderate to high complexities.

●Tracking, managing and monitoring all changes to study scope ensuring timely change order finalization and implementation.

●Developing strategies to maximize the company’s profitability and minimize company’s turnover.

●Assisting in the training of clinical operations team to get them familiar with our internal financial tracking applications and software (Clinbid, SFDC, SharePoint).

●Conducted a multi-sets budget audits to investigate short falls, reconcile budgets and project financial venues of improved dividends.

Evidera/United BioSource Corporation/Metaworks: Lexington, Massachusetts (2005-2016).

Research Associate III (2014-2016):

●Wrote proposals, protocols and reports.

●Analyzed data outputs from literature reviews, database vendors and SAS programmers.

●Generated statistical analysis plans for database studies.

●Assumed the role of principal investigator and lead author on reports for pharmaceutical companies.

●Assumed the role of project manager for both the financial and scientific sectors of projects.

●Participated in Modeling/Simulation projects to identify the cost of Traumatic Brain Injury treatment.

●Performed Real World Evidence database reviews using external database sources.

●Participated in research collaboration between pharmaceutical companies and academic institutions.

●Prepared manuscripts and abstracts for publication.

●Conducted a meta-analytic extraction and quality check data from scientific papers.

Research Associate II (2009-2014):

●Managed several projects (functionally and financially) to meet deadlines and quality.

●Wrote proposals, protocols and reports. Prepared manuscripts and abstracts for publication.

●Created a 400 clinical terms coding algorithm database for a US-UK-based Merck project.

●Built coding algorithms from literature and from Ingenix Encoder Pro.

●Created an Excel database of > 800 databases/registries worldwide for Pfizer.

●Worked on the FDA Mini-Sentinel Project to identify the coding algorithms for 5 health outcomes utilizing claims-based diagnosis and procedure codes from literature studies. The project can be found at: http://www.mini-sentinel.org/methods/outcome_identification/default.aspx

●Worked on the Creation of Risk Management Plans (RMP) for both FDA and NICE submissions.

●Conducted literature review on epidemiology, systematic and rapid literature reviews.

●Quality checked literature reviews, RMP data, meta-analysis, reports, protocols and proposals.

●Attended International Society for Pharmaceutical Engineering (ISPE) meeting in 2009.

Project Manager (2007-2009):

●Worked on various projects and managed the budget of more than 30 projects.

●Supervise a team of Senior Scientist, Epidemiologist, Clinical Information Specialist, Data Analyst and Research Assistants.

●Wrote proposals, protocols and reports.

●Assumed the role of principal investigator and lead-author on reports for pharmaceutical and general scientific companies.

●Provided software and application training to selected staff members (SAS, Microsoft Visio, SharePoint, Access, Publisher and InfoPath).

●Worked with EMR and Claims databases to collect information on the HIV population.

●Conducted literature review on epidemiology, systematic and rapid literature reviews.

●Prepared manuscripts and abstracts for publication.

●Prepared and reviewed Standard Operating Procedures (SOPs).

Research Analyst (2005-2007):

●Conducted systematic literature reviews (epidemiology and rapid) and database analysis for pharma-companies.

●Built a pediatric medical database and conducted literature reviews for National Institute of Child Health and Development (NICHD).

●Conducted a safety study for Consumer Health Product Association (CHPA) that reviewed the dosage proportions for the pediatric population.

AOL/Time Warner: Boston, Massachusetts.

Freelancer Content Contributor (2004-2005):

●Interviewed and collected dynamic data to identify salient factors of 5 African inter-ethnic wars.

●Wrote memoranda findings.

International Center for Environmental & Nuclear Sciences: West Indies University, Jamaica (2002-2003)

Scientific Officer :

●Operated, troubleshot and analyzed results of Atomic Absorption Spectrophotometer (AAS) and Flame Induced Atomic Absorption (FIAA).

●Utilized wet chemistry and substance extraction to test heavy metals in plant and soil samples.

●Documented salient electronic scientific records/results and logged them into presentation logbooks.

●Quality checking laboratory processes and validating relevant protocols.

●Researched the level of Cadmium in kidneys/livers of Jamaican deceased population during autopsy.

●Analyzed and researched the elemental composition of Jamaican food and soil.

●Researched and analyzed the blood lead levels in children of elementary schools in Jamaican (including working directly with children who had seizure disorders and their close family members).

Salem State University: Salem, Massachusetts (1997-1998).

Research Assistant:

●Performed literature searches to support research.

●Utilized Nuclear Magnetic Resonance (NMR), Gas Chromatography (GC), Infrared Spectrophotometer (IR), High Performance Liquid Chromatography (HPLC), Atomic Absorption (AA) and Ultraviolet-Visible Spectroscopy (UV-VIS) to carry out organic and inorganic synthesis.

●Performed protein separation using Gel Electrophoresis.

REFERENCE: furnished upon request.

Publications (published under my maiden name; Natalie Jones - now Natalie Bazangoula):

1.Jones N, Schneider G, Kachroo S, Rotella P, Avetisyan R, Reynolds MW. A systematic review of validated methods for identifying acute respiratory failure using administrative and claims data. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:261-4.

2.Jones N, Schneider G, Kachroo S, Rotella P, Avetisyan R, Reynolds MW. A systematic review of validated methods for identifying pulmonary fibrosis and interstitial lung disease using administrative and claims data. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:256-60.

3.Schneider G, Kachroo S, Jones N, Crean S, Rotella P, Avetisyan R, Reynolds MW. A systematic review of validated methods for identifying hypersensitivity reactions other than anaphylaxis (fever, rash, and lymphadenopathy), using administrative and claims data. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:248-55.

4.Schneider G, Kachroo S, Jones N, Crean S, Rotella P, Avetisyan R, Reynolds MW. A systematic review of validated methods for identifying anaphylaxis, including anaphylactic shock and angioneurotic edema, using administrative and claims data. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:240-7.

5.Schneider G, Kachroo S, Jones N, Crean S, Rotella P, Avetisyan R, Reynolds MW. A systematic review of validated methods for identifying erythema multiform major/minor/not otherwise specified, Stevens-Johnson Syndrome, or toxic epidermal necrolysis using administrative and claims data. Pharmacoepidemiol Drug Saf. 2012 Jan;21 Suppl 1:236-9.

6.Reynolds MW, Shibata A, Zhao S, Jones N, Fahrbach K, Goodnough LT. Impact of clinical trial design and execution-related factors on incidence of thromboembolic events in cancer patients: a systematic review and meta-analysis. Curr Med Res Opin. 2008;24:497-505.



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