RN / Project Mgr / Clinical Data Mgr

EDUCATION

Bachelor of Arts, English Literature (Dean’s List), Marian University, Indianapolis, IN.

Bachelor of Arts, Music Performance (Dean’s List), Marian University, Indianapolis, IN.

Teaching License, Secondary Education, Marian University, Indianapolis, IN.

Associate of Science, Nursing, (Dean’s List) Ivy Community College, Columbus, IN.

SELECTED PROFESSIONAL EXPERIENCE

Emily Program, Durham, NC Registered Nurse / Preceptor

Jan 2024 – present

Providing in-patient and residential nursing care (report, RX administration, first aid, lab draws and review) and mental health support to children diagnosed with a mental health diagnosis paired with eating disorders.

Educating patients, parents, and new hires in process and procedure, insurance requirements, and clinical judgment.

Conducting close observation and suicide watch as needed to ensure patient safety and prevent self-harm.

Saama Technologies, Durham, NC Assoc. Dir. – Clinical Business Transformation

MAR-2022 to JUN-2023

Project Mgmt:

Led app training initiatives by adding AI into clinical trial processes.

Amended clinical trial design/programming to conform to Saama's AI / ML ingestion mapping algorithm.

Timeline development and internal resource acquisition for small/medium contracts.

Clinical Data Mgmt:

Assisted clients with process conversion of EMR builds to allow AI / ML benefits for Veeva and Rave users.

Reviewed document deliverables (e.g. DMP, ALS) for compliance with CDISC / HIPAA / FDA requirements.

Contributed to company CDM matrix, GCDMP guidance, & product release committees.

ICON, PLC, Durham, NC. Clinical Data Mgr / Rave UX Designer

MAY 2020 to MAR-2022

Piloted the use of Amazon AWS to replace sFTP protocol for external vendors.

Customer Service Awards: Solved design problem with collecting intra-tumoral injections in 3D space on an eCRF.

Company teamwork award - teamwork during an RFP added 2 cancer trials to the oncology portfolio.

Created study-specific training manuals reinforcing AI integration.

IBM Watson Health, Durham, NC Clinical Data Manager / Designer

MAY-2016 to NOV-2019

Designed 20 new clinical trial databases from client protocol and CRFs for Phase I-III trials, registry trials, and adjudication.

Project manager for weekly meetings with client, managed process deliverables and customer timelines.

Brought medical and clinical process thinking into the programming process.

Introduced coding dictionaries (ICD-9, CPT, WHODrug) into programming process.

Lead EDC initiatives: new shippers (web services and sFTP), payment (Greenphire).

Identified process improvements (e.g. introducing CDISC standards to clients).

Clinical SME to various Watson Health teams.

ConvaTec, Greensboro, NC Clinical Safety Specialist - Contract

NOV-2013 – FEB-2014

Assisted in the deployment of remediation plan following RCA and issuance of FDA Form 483. Evaluated five years of consumer complaints across four product lines for potential AEs / SAEs. Utilized Oracle Clinical and ARISg system (and WHO Drug) for creating / amending cases.

Consulted with upper management after the failure of first remediation plan.

Assisted with the creation of a second remediation plan; accepted by FDA.

Performed 1st round of clinical assessment; wrote associated MedWatch forms.

Novella Clinical, Morrisville, NC Clinical Nurse Monitor - Contract

JUL-2013 – OCT-2013

Short-term contract preceding purchase by Quintiles. Provided pre-database lock data review for oncology trial; transitioned to a NDA mid-study. Expedited query cycle within InForm environment.

Provided training / logistical support to Clin Ops based in Europe / Asia.

Resolved escalated issues presented by Regional CRAs / Study Project Managers.

Rescued data from three sites with superior customer service skills.

Quintiles, Raleigh, NC Clinical Safety Specialist RN - Contract

NOV 2012 – FEB 2013

Short-term contract to address bolus of clinical data as 21,000 global subjects with a common study end date. Utilized ARISg and proprietary systems to create or amend SAE cases.

Composed initial and amended follow-up of MedWatch clinical narratives.

Entered MedDRA / WHO Drug code when auto-coding verbatims failed.

Reviewed digital documents for completeness; noted deviations to prevent CAPA.

Lundbeck Pharmaceuticals, Lincolnshire, IL Clinical Data Manager - Contract

NOV 2010 - FEB 2011

Assisted CDM by increasing department bandwidth as they transitioned from being Ovation Pharmaceuticals. Assisted multiple teams while reviewing new SOPs for quality and completeness.

Discovered process error in self-evident corrections as part of DVP boilerplate.

Reviewed all boilerplate documents in CDM.

Scanned and manually uploaded patient and caregiver diaries.

Abbott Laboratories / AbbVie Clinical Safety Analyst - Contract

APR 2010 – OCT 2010

The Clinical Safety Associate was responsible for AE / SAE processing from intake to close. This included dossier creation, Medical Director review, narrative creation, and MedWatch 1500A form completion. Job included defense of sibutramine / Meridia.

Ensure SAEs from clinical trials are processed according to FDA / SOP guidelines.

Prepared adjudication briefs for Medical Monitor, Sponsor Physician, and Legal.

Reviewed safety related data for content, quality, and adherence to GCP guidelines.

Creation / QA of narrative assessments in pain, renal, and dyslipidemia therapeutic areas.

SELECTED ACCOMPLISHMENTS

Mentorship Service Award 2023 – teaching new female graduates in India the fundamentals of clinical trial design, networking, and resilience through the LeanIn program.

Inspire Award 2021 - pioneered use of Amazon AWS, Cyberduck, and EKG wearable device to support Fitbit trials.

Inspire Award 2020 - knowledge of Intra-Tumoral Injection studies lead sponsor to award ICON two additional studies.

Medications (brought to market): Actos (pioglitazone), Alimta (pemetrexed), FloMax (tamsulosin), Humira (adalimumab), and Imitrex (sumatriptan).

Medications (expanded indications): Fosamax (alendronate sodium), Gemzar (gemcitabine), Onfi (clobazam), Vicoden (acetaminophen and hydrocodone), Vicoprofen (ibuprofen and hydrocodone).

Defended Meridia (sibutramine) to the FDA post-market approval.

Discovered error in protocol design prior to distribution and prevented three global protocol amendments (prevented $170,000 overrun).

PROFESSIONAL DEVELOPMENT

Project Management for Trainers - Langevin

Rave User Training & Designer Training - Metadata

eClinical Designer Training and Certification - IBM

IBM Clinical Development Designer Certification - IBM

Cross Training: SAS VA, Smart Reports, J-Review, CTMS, ePRO

Rave Designer Training - ICON University

300+ credit hours in continuing education - NCNA

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