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Lead Clinical Data Manager / SAS Programmer

Location:
Bethesda, MD
Posted:
April 29, 2015

Contact this candidate

Resume:

G regory S. Tullo

***A Spitz Lane

Basye, VA ****0

703-***-****

****.*****@*****.***

QUALIFICATIONS

As the lead clinical data manager and director of our data management team, it has been my responsibility

to lead the data management team of the Laboratory of Malaria and Vector Research in all data collection,

processing, and data management needs from study start-up through data lock. This includes, but is not

limited to the design of custom data collection plans using the Clinical DataFax hybrid EDC system,

management and quality assurance of collected data, and post processing of data using custom SAS

programs for the generation of general descriptive statistics, analysis datasets, and reports. In addition, I

have created custom data management solutions for researchers and analysis based on their needs. Much

of my work includes project management of several concurrent clinical and non-clinical studies,

responding to ad-hoc data summary requests, the generation of data management solutions and plans, and

the supervision of several data managers and data entry personnel. The vast majority of this work is

performed from a home-based office with minimal oversight.

EXPERIENCE

Laboratory of Malaria and Vector Research, January 2011 – Present

Kelly Scientific Resources

National Institutes of Health – Bethesda, MD

Lead Clinical Data Manager

Generate custom SAS programs and macros for users which generate data subsets of interest,

descriptive statistics, and reports.

Lead data standardization efforts including proper MedDRA coding and migration to CDISC

standards.

Create all digital and paper CRFs.

Program all edit checks in EDC system using a C-family programming language.

Organize data collection operations and manage data management staff in all remote field sites

(Mali, Cambodia) including remote training sessions.

Act as liaison between field site investigators and monitoring groups/cyber infrastructure teams.

Oversight of data query generation, reporting, and resolution including regular ‘batch’ quality

control queries.

Manage the Clinical DataFax system, which uses Intelligent Character Recognition (ICR) for

collection of data from scans of paper CRFs; a system which greatly reduces the time from data

collection to data availability to research teams.

Provide regular reports on data validation efficiency and accuracy, query resolution time, and

other requested metrics through database lock.

Accomplishments include:

- Expanded use of DataFax to include eight clinical studies and three novel data collection uses

of the system. The effort has resulted in the ability to run more studies concurrently while

collecting vastly more data and yet allowing the generation of custom reports, datasets, and

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simple statics with ease. The creation of such datasets prior to the system was a process

which took weeks and was highly error prone. It now takes a matter of minutes to create high

quality, valid results with an error rate of less than one percent.

- Created a barcoded labeling system which interfaces with DataFax. This system

increased the sample collection count fivefold, reduced the sample logging time from

an estimated two or more weeks to three or four days, and vastly increased accuracy.

Laboratory of Malaria and Vector Research, January 2008 – December 2010

Kelly Scientific Resources

National Institutes of Health – Bethesda, MD

Research Scientist II

Worked as ‘defacto’ data manager until official position was created in 2011.

Lead the effort in the implementation of the Clinical DataFax hybrid EDC system for all clinical

studies.

Managed all pre-DataFax data from a large cohort clinical study (see Lopera-Mesa et al 2015) and

migrated this data into the DataFax system.

Member of ‘Growth Inhibition Reference Center’ and responsible for testing of malaria vaccine

candidates from outside clients.

Maintained positive working relationships with clients who were often competing for same

discovery.

Accomplishments include:

- Proposed the creation of lead clinical data manager / director of data management position

and was appointed to that position.

- Implemented Clinical DataFax system resulting in a reduction in time from field data

collection to delivery in the lab from over one month to one week, increased the number of

data samples collected by an order of magnitude, and reduced historical data collection error

rate from over 10% to less than 1%.

- Created custom database for a group working on a four year longitudinal cohort study which

allowed all members of the team to independently query a dataset of close to one million data

points in a matter of seconds rather than the hours needed before the system was created.

University of Kentucky, Markey Cancer Center – Lexington, KY 2006 – 2007

Undergraduate Independent Research under John D’Orazio, M.D., Ph.D.

Created an Excel workbook which enabled researchers to quickly determine correct exposure time

for various UVA and UVB doses as well as the correct amount of DNA suspension to load for

southwestern blots.

Investigated the role of the Melanocortin-1 Receptor in nucleotide excision repair and oxidative

damage repair in melanocytes exposed to UVA irradiation in a transgenic murine model

Conducted procedures such as southern blots, western blots, primer design, cell culture, animal

handling, DNA isolation, DNA purification, DNA manipulation, PCR, and interpretation of

sequencing data.

Introduced and developed technical aspects of southwestern blotting to quantify DNA damage in

skin biopsies caused by UVA and UVB irradiation.

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RELEVANT SKILLS

Base SAS programming language including automated macros

Familiarity with GCP, GCDMP, MedDRA, and CDISC

CRF design

Regular entry, validation, export, and manipulation of data collected in EDC systems

Edit check programming

General knowledge of C programming language

Expert user of Microsoft Office Suite including Excel and Access

Project management skills

Comfortable public presenter

Experienced leader of focused teams

EDUCATION

Bachelor of Science, Biology. University of Kentucky, Lexington, KY May 2007

Relevant courses include: Reemerging Infectious Diseases, statistics, recombinant DNA

techniques, genetics, cell and molecular biology, organic chemistry, physics, animal physiology.

Independent research of Melanocortin-1 Receptor under John D’Orazio, M.D., Ph.D.

PUBLICATIONS

Amaratunga, C., S. Sreng, S. Mao, G. S. Tullo, J. M. Anderson, C. M. Chuor, S. Suon and R. M. Fairhurst

(2014). "Chloroquine remains effective for treating Plasmodium vivax malaria in Pursat province,

Western Cambodia." Antimicrob Agents Chemother 58(10): 6270-6272.

Bei, A. K., A. Diouf, K. Miura, D. B. Larremore, U. Ribacke, G. Tullo, E. L. Moss, D. E. Neafsey, R. F.

Daniels, A. E. Zeituni, I. Nosamiefan, S. K. Volkman, A. D. Ahouidi, D. Ndiaye, T. Dieye, S.

Mboup, C. O. Buckee, C. A. Long and D. F. Wirth (2015). "Immune characterization of Plasmodium

falciparum parasites with a shared genetic signature in a region of decreasing transmission." Infect

Immun 83(1): 276-285.

Christian, P. V., J.; Scott, T.; Tullo, G.; D’Orazio, J.A. (2011). "Epidermal Pigmentation, Nucleotide

Excision Repair and Risk of Skin Cancer." Carcinogenesis & Mutagenesis.

Guo, J., J. A. McQuillan, B. Yau, G. S. Tullo, C. A. Long, P. Bertolino, B. Roediger, W. Weninger, G. A.

Taylor, N. H. Hunt, H. J. Ball and A. J. Mitchell (2015). "IRGM3 Contributes to Immunopathology

and Is Required for Differentiation of Antigen-Specific Effector CD8+ T Cells in Experimental

Cerebral Malaria." Infect Immun 83(4): 1406-1417.

Lopera-Mesa, T. M., S. Doumbia, D. Konaté, J. M. Anderson, M. Doumbouya, A. S. Keita, S. A. S.

Diakité, K. Traoré, M. A. Krause, A. Diouf, S. E. Moretz, G. S. Tullo, K. Miura, W. Gu, M. P. Fay,

S. M. Taylor, C. A. Long, M. Diakité and R. M.

Fairhurst (2015). "Effect of red blood cell variants on childhood malaria in Mali: a prospective cohort

study." The Lancet Haematology 2(4): e140-e149.

Miura, K., B. Deng, G. Tullo, A. Diouf, S. E. Moretz, E. Locke, M. Morin, M. P. Fay and C. A. Long

(2013). "Qualification of standard membrane-feeding assay with Plasmodium falciparum malaria and

potential improvements for future assays." PLoS One 8(3): e57909.

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Miura, K., M. Diakite, A. Diouf, S. Doumbia, D. Konate, A. S. Keita, S. E. Moretz, G. Tullo, H. Zhou, T.

M. Lopera-Mesa, J. M. Anderson, R. M. Fairhurst and C. A. Long (2013). "Relationship between

malaria incidence and IgG levels to Plasmodium falciparum merozoite antigens in Malian children:

impact of hemoglobins S and C." PLoS One 8(3): e60182.

Miura, K., E. Takashima, B. Deng, G. Tullo, A. Diouf, S. E. Moretz, D. Nikolaeva, M. Diakite, R. M.

Fairhurst, M. P. Fay, C. A. Long and T. Tsuboi (2013). "Functional comparison of Plasmodium

falciparum transmission-blocking vaccine candidates by the standard membrane-feeding assay."

Infect Immun 81(12): 4377-4382.

Miura, K., H. Zhou, A. Diouf, G. Tullo, S. E. Moretz, J. A. Aebig, M. P. Fay, L. H. Miller, O. K.

Doumbo, I. Sagara, A. Dicko, C. A. Long and R. D. Ellis (2011). "Immunological responses against

Plasmodium falciparum Apical Membrane Antigen1 vaccines vary depending on the population

immunized." Vaccine 29(12): 2255-2261.

Zeituni, A. E., K. Miura, M. Diakite, S. Doumbia, S. E. Moretz, A. Diouf, G. Tullo, T. M. Lopera-Mesa,

C. D. Bess, N. K. Mita-Mendoza, J. M. Anderson, R. M. Fairhurst and C. A. Long (2013). "Effects of

age, hemoglobin type and parasite strain on IgG recognition of Plasmodium falciparum-infected

erythrocytes in Malian children." PLoS One 8(10):e76734.

Zhang, Y., K. Miura, J. Li, G. Tullo, F. Zhu, L. Hong, T. Lin, X. Z. Su and C. Long (2012). "Macrophage

migration inhibitory factor homolog from Plasmodium yoelii modulates monocyte recruitment and

activation in spleen during infection." Parasitol Res 110(5): 1755-1763.

REFERENCES

References available upon request

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