Data Standards Consultant

Resume

Objective

As a Clinical Data Scientist and Consultant I work within a data delivery team to guide teams in use of internal and external standards.  As part of this team I utilize analytical, technical, and communication skills developed while working for over 10 years on clinical trials involving clinical data standards and clinical pharmacokinetics.


Experience

2012 - Present

Eli Lilly and Company

Teleworker Based in New Milford CT

Consultant Data Standards within Global Data Delivery

 Influence, define, and instantiate core and therapeutic area standards for broader reusability and drive toward consistency; understand, influence, and incorporate industry standards (CDASH, SDTM, ADaM, ODM).

Represent Lilly and Global Data Delivery as part of multiple SDTM controlled terminology teams, while continuing to lead the PK terminology team with CDISC.

Define, implement and manage the processes and technologies to support the Clinical Data Flow from data collection through analysis/integrated databases/submission deliverables.

Support the portfolio by enabling delivery of observed and analysis data at the study along with delivery of PK data sets, Integrated Data Bases and submission deliverables.

Providing solution consultation to support CDF processes utilizing process, technology, standards, vendor management, data and regulatory expertise/knowledge, e.g. eSource, CFR 21 Part 11, guidance documents. Developing standards to be used and followed at each stage of the clinical trial dataflow.

Maintaining libraries of clinical trial data standards, making them accessible to all Lilly personnel.

Ensuring facility of data transfer between Lilly and external partners by defining relationships between internal and external standards.

Developing metadata used to control and automate the clinical trial dataflow process.

 

2005 - 2012

Boehringer Ingelheim Pharmaceuticals Inc.

Ridgefield, CT


Feb2012 – Nov2012

Clinical Site Information Specialist III

-Develop and maintain a sufficient pre-qualified number of investigators to meet trial specific timelines and requirements.

- Serve as a liaison with internal departments and sites while collecting trial specific investigator/site requirements to continually prequalify potential investigators.

-  Develop and analyze information from the investigator systems, conducting screens, contributing to the development of metrics, reporting/analysis/tracking this information. Then aggregating this with monitoring information to identify performance and trends.

-  Mentor specialists and database technicians on entry, maintenance, and reporting from the BI Investigator systems.

-  Proactively identify operational problems, obstacles, and barriers for the investigator systems and screen process and recommend improvements where delays and opportunities occur.

2009-Jan2012

Data Management Specialist II

Trial data manager (TDM) responsible for the database set-up in Oracle*Clinical and design of the eCRF for the collection of clinical trial data, including programming of data plausibility checks.

 Review and process clinical trial data to ensure the accuracy and consistency of the clinical trial database, coordinated and conducted trial team review of data via Medical Quality Review Meetings.

Presented at investigator meetings the content and completion expectations of the eCRF.

Collaborate with international clinical sites and clinical research associates in resolution of open data issues and requests.

Collaborate and provide input on project and trial protocol reviews.

Direct international pharmacokinetic data flow harmonization and innovation efforts with IT through implementation and development of a file validation PKChecker tool currently used in several international Medical and R&D teams.

 Lead the international CDISC –SDTM PK terminology team of industry leaders specializing in standards development for PK modeling through weekly meetings to collaborate and produce the international implementation guide and standards for PK.  The SDTM domains were rolled out in 2009.

TDM for two trials:  1100.1526 - Nevirapine XR and 1220.47-  BI 201335 (Hepatitis C)

1100.1526:  Expedited database design through collaboration with the clinical trial team prioritizing site and investigator access, tracking data entry metrics and identifying data flow abnormalities.  Successfully managed interim locks of the trial database at two separate time points.

1220.47:  Pilot trial for new corporate database structure (SDTM+). Team member helping to direct and implement the new processes and standards including a database set up structure that will be scalable for all other clinical trials. In addition have helped to implement and execute a new by patient lock process.

Achievements and Awards:

Strengthened the pharmacokinetic data process by assuring standards are adhered to for over 30 clinical trials across four therapeutic areas (Virology, Oncology, CNS, and Metabolic).  Received special recognition from CDISC consortium on my contributions to the PK terminology team.

Promotion to Specialist II in July of 2010.

Presented with a REACH award from International Medical Management for supporting Pradaxa’s FDA approval.

 Presented with a REACH award from International Medical Management for working on the ICBI+ ADaM Pilot Team.

Awarded with two Golden Achievements from Medical & BDM for database locks in abbreviated timelines for the 1100.1526 nevirapine extended release formulation submissions.

2005-2008

Scientist II Clinical Pharmacokinetics

Conducted protocol reviews, planning/scheduling of analysis and clinical trial report generation for pharmacokinetics sections on 47 clinical trials across 7 therapeutic areas (Respiratory, Virology, Oncology, CNS, Metabolic, Immunology, and Inflammation).

Collaborated and trained Data Management colleagues internationally on the data transmission structure and content.

Analysis key user collaborating with several international harmonization teams. 

Lead the protocol to report team where I implemented transition in workflow and tools.   Prioritized and organized the QC of all pharmacokinetic and pharmacodynamic analysis and CTR sections for the local Trial Clinical Pharmacokineticist.

Achievements and Awards:

Promotion to Scientist II after extensive contributions to the tipranavir submission, collaborated on investigator-initiated studies, and implementing training for the protocol to report team.

Golden Achievement award for an oncology protocol review within an abbreviated timeline.

 

2003 - 2005

Instrumentation Laboratory

Orangeburg, NY

R&D Scientist & Quality Assurance Analyst II

§  Developed IL coagulation instrumentation and reagent testing on new products while performing stability testing for date extension, lab bench work, wrote technical reports and presented analysis in tables and graphs for presentations and research papers. 

Executed quality assurance testing via comparison to SOPs and QC Monographs on FDA retain and return clinical chemistry, CO-oximeter, coagulation, and microbiology controls and reagents. 

Analyzed techniques executed in accordance with established quality standards and GMP requirements and reported findings on poor manufacturing quality and instrument accuracy.  

 Lead instrumentation software reprogramming, troubleshooting, and calibration. 

 Lead pilot trials and beta testing of new platforms and reagents. 

 Monitored health, safety, and regulatory procedures as the safety representative for our team.

Implemented ISO audits as part of an audit readiness team.

 

Technical Skills

Analysis and Reporting tools: ORACLE*Clinical, Remote Data Capture, Accenture Quantum Regulatory Information Management (RIM), Phoenix WinNonlin, S-Plus, Excel, J-Review, Formedix OSM, CDISC (CDASH, SDTM, ADaM, & ODM) standards, and SAS.

Other:  IDEA, CTMS, and Yammer. Wharton conference training in: Leading through Adversity, and training from The University of Arizona in: Pharmacokinetics and Toxicokinetics for the Industrial Scientist, and Octagon’s CDISC SDTM training.


Education

2014

University of Liverpool

Liverpool, UK

Post Graduate Diploma in Public Health with Merit

2001                                                      

Long Island University                                                                     Southampton, NY

Bachelor of Science: Major in Environmental Science & Concentration in Biology

Awards: 2001 Senior Class President, Dean of Students Award, Provost Citizenship Award, Merit Award, Junior Class President, Student Chief Marshal for the Class 2000 Commencement, CMERS intern, and certificate of appreciation from the US Department of Commerce during my internship with NOAA.

 

Published Material

 

Sabo, J.P., Cong, X.J., Kraft, M.F., Wallace, L., Castles, M.A., Mauss, S., MacGregor, T.R. Lack of a pharmacokinetic interaction between steady-state tipranavir/ritonavir and single-dose valacyclovir in healthy volunteers. Eur J Clin Pharmacol. 2011;67(3), PP:277-81.

 

Wikfors, G.H., Alix, J.H., Smolowitz, R.M., Wallace, L., Hégaret, H. Detrimental effects of a recent Prymnesium isolate from Boothbay Harbor, Maine (USA), upon juvenile bay scallops, Argopecten irradians. Journal of Shellfish Research. 2002;21, PP:397.


References available upon request.

© Lacey Wallace 2015