Associate Director, Clinical Data Management

EXPERIENCE

**/**** – Present Associate Director, Clinical Data Management

Karuna Therapeutics (A Bristol Myers Squibb Company) – Boston, Massachusetts

Therapeutic Area(s):

oPsychiatry

oCNS

Sponsor Oversight:

oOversee clinical data management activities for clinical programs

oProvide oversight of vendor clinical data deliverables for clinical programs

oWork with Karuna’s functional service provider for clinical data management for each clinical program

Hands-On Data Management:

oDirect core clinical data management activities: CRF (Case report forms) design, clinical database development, validation definitions and programming, discrepancy management, data extracts, and database locking and archiving.

oIdentify, evaluate, manage, and resolve issues related to clinical data.

oCollaborate with other Karuna colleagues and departments, such as statistics and statistical programming, pharmacovigilance, clinical operations, regulatory affairs, medical directors, and other functions supporting clinical programs.

Departmental Infrastructure & Governance

oSupport the clinical data management strategies developed for Karuna and provide feedback and suggestions to improve Karuna’s CDM strategy.

oDevelop and refine clinical data management governance documentation, including SOPs (Standard Operating Procedures) and work instructions.

oAdhere to departmental and regulatory agency procedures and standards.

Highlights/Successes

oDM SME for successful FDA Inspection of KAR-XT (Emergent Program) 2024

oSupported KAR-XT NDA submission 2023

oLed DM oversight initiative: Data Planning and Risk Mitigation 2023

oRe-vamped a comprehensive departmental oversight SOP aligned with FDA BIMO Compliance Program 2024

oDM Program Lead for newly acquired asset 2024

oLed hiring efforts for Associate Director and Senior Manager roles in DM department 2023

oDM SME for eCS elluminate visualization implementation 2024

06/2021 – 05/2023 Senior Manager, Clinical Data Management Quality Standards

Agios Pharmaceuticals – Cambridge, Massachusetts

Therapeutic Area(s):

oRare Disease – PKD, SCD, Thalassemia, MDS

Data Quality Projects:

oPerformed audits to ensure that the internal and DM (Data Manager) Vendor staff complete activities according to defined processes and specified quality standards

oPerformed data and query audits to ensure internal and DM Vendor staff are cleaning data according to specified quality standards

User Acceptance Testing Strategy:

oReviewed and created user acceptance test (UAT) plan/ scripts for quality and completeness of electronic data capture (EDC) systems including Electronic Clinical outcome assessment (eCOA) systems

oPerformed UAT (Screen setup testing and Edit checks testing) to ensure high quality EDC / eCOA system setup, compliance with industry and Agios best practices

oScheduled and led meetings to provide feedback on the UAT issues to the project team (internal/vendor)

Process Improvement:

oAssessed trends in data and process audits and communicates lessons learned and recommends process improvements

oReviewed study documentation and plans ensuring data quality is consistent with DM best practices, standards, and procedures

oWorked with Clinical Data Systems to define requirements and to implement automated data review solutions for audit trails, local lab data management, and other areas that benefit from standardization

Highlights/Successes

oLed development of Agios Global Standards Library

CRFs (Case report forms) and edit checks in alignment with specifications

Created complete suite of standard data review metrics

oAdministered Centralized Data Review program

Piloted QC of Query Quality program to support internal data audits

Developed Audit Trail Review program and trained junior DM staff to execute quarterly review to support data quality improvement

08/2020 – 04/2023 Manager, Clinical Data Management Standards

Kite Pharma (A Gilead Company) – Santa Monica, California

Therapeutic Area(s):

oOncology

oCell Therapy

Sponsor Oversight:

oWorked collaboratively and cross-functionally to meet project deliverables and timelines for moderately complex clinical data acquisition, quality checking and reporting.

oEnsured completeness, accuracy and consistency of clinical data and data structure across all projects.

Departmental Infrastructure & Governance

oTrained and mentored of CDM staff on business processes and clinical programs.

oParticipated in the development, review and implementation of processes, policies, SOPs, and associated CDM documents

oParticipated in CDM and cross functional initiative teams.

Hands-On Data Management:

oCommunicated and escalated project level issues including processes, timelines, resourcing, performance, etc.

oSupported regulatory submission activities for assigned projects.

oCommunicated with functional peers regarding project status and issues and ensures project team goals are met.

Training and Mentorship:

oParticipated in the recruiting and hiring process for CDAs

oProvided guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.

Highlights/Successes

oSelected as Data Management SME for Kite Global Library Standards team

oSupported the successful FDA approval of Yescarta - 2022

12/2019 – 08/2020 Clinical Data Manager

Tesaro Inc. (A GSK Company) – Waltham, Massachusetts

Therapeutic Area(s):

oOncology

Hands-On Data Management:

oProvided data management expertise as lead on clinical study

oIndependently performed tasks related to database and report setup, as well as processing, review and cleaning clinical trial data, following all applicable standard and study-specific procedures

oCreated and reviewed data point listings and patient profiles to determine trends and assess data quality risks

oDeveloped test scripts, created test data and performed UAT on new and updated EDC systems

oCreated and maintained process specific guidelines

oPerformed Manual listing review for SAE (Serious Adverse Event) and lab reconciliation

06/2017 – 12/2019 Senior Lead Clinical Data Coordinator

ICON (formerly PRA Health Sciences) – Raleigh, North Carolina

Therapeutic Area(s):

oOncology

oCNS

oPediatrics

oSepsis

oHealthy Subjects

●Senior Lead Analyst over team of six (6) Lab Data Coordinators

●Created and managed study timelines tracker for Start-Up, Maintenance & Close-out Milestones for a portfolio of 22 complex multi-indication protocols

●Managed the progress of LDC task completion across the group

●Liaised with Lead Data Managers and Lab Data Coordinators to maintain adequate resourcing throughout the study duration

●Trained and mentored junior team members

●Created new Local Lab Conventions, Lab Listing Specifications, and various templates

●Performed Medidata Rave UAT using test subjects and data

●Performed complex protocol review and extrapolation of protocol-specific analytes

●Reviewed Edit Check Plan (ECP), Data Validation Specifications (DVS), annotated Case Report Forms (aCRFs)

Highlights/Successes

oPromoted with dual role: Lead CDC & Local Lab SME – January 2018

oServed as acting Lead Data Manager – August 2018

Created a development program for Local Lab Data Coordinators

06/2016 – 06/2017 Senior Clinical Data Associate

Syneos Health (formerly INC Research) – Raleigh, North Carolina

Therapeutic Area(s):

oOncology

oCNS

Highlights/Successes

oDeveloped and implemented an innovative LNR QC (Quality Control) Status Tracking Tool and LNR Document Managing System/Process

oServed as the subject matter expert for Lab Normal Ranges (LNRs) for five projects – point person to reconcile and resolve lab normal issues with site/CRA/sponsor/DM

oHeaded up a central labs and PK reconciliation project for over 3000 subjects resulting in a successful, on-time database lock of a phase III fibromyalgia trial

oCreated all data management plans (DMP) and electronic case report form collection guidelines (eCCGs) on multiple ‘rescue’ trials

01/2016 – 06/2016 Clinical Site Associate (In-House CRA)

IQVIA Biotech (formerly Novella Clinical – A Quintiles Company) – Morrisville, North Carolina

Therapeutic Area(s):

oOncology

●Served as an in-house CRA responsible for site management, data review, and query resolution management on Phase I/II prostate and breast cancer trials

●Provided in-house content expertise on assigned sites (e.g., patient enrollment, protocol compliance, study site staff issues, IRB (Institutional Review Board) and regulatory document status, data status, and other site metrics)

●Performed study evaluation, initiation, remote monitoring, and close out visits via WebEx and teleconference

●Advised as primary liaison between Novella and the investigative sites and managed the proper documentation of site management communications.

11/2014 – 01/2016 Clinical Research Coordinator

UNC Lineberger Comprehensive Cancer Center – Chapel Hill, North Carolina

●Therapeutic Area(s):

oOncology

06/2013 – 11/2014 Clinical Data Coordinator

Duke Comprehensive Cancer Center – Durham, North Carolina

●Therapeutic Area(s):

oOncology

09/2011 – 12/2012 Graduate Research Associate

Tufts University Friedman School of Nutrition – Boston, Massachusetts

Public Health Pediatric Exercise Study – NIH (National Institutes of Health)

●Therapeutic Area(s):

oPediatrics - Healthy Subjects

Vitamin D Pediatric Nutrition Study

●Therapeutic Area(s):

oPediatrics - Healthy Subjects

04/2010 – 08/2011 Clinical Data Technician

Duke Comprehensive Cancer Center – Durham, North Carolina

●Therapeutic Area(s):

oOncology

ACADEMIC QUALIFICATIONS

●Master of Science

oGlobal Nutrition Policy – Tufts University 2014

●Bachelor of Science

oPhysiological Psychology – University of Maryland Baltimore County 2010

SYSTEMS APPLICATIONS TECHNICAL SKILLS

●CDMS/EDC: Medidata Rave/ RaveX, Trial Grid, Oracle Clinical, Inform, VeevaVault, Bioclinica, Perceptiv, REDCap, DataLabs

●Visualization & Reporting Tools: eClinical Solutions/elluminate, RAVE Reporter, JReview, BOXI, Spotfire

●Electronic Trial Master Files (eTMF): PhlexEview, eTMF3, VeevaVault, Trial Interactive

●CTMS: ProjectPoint, TeamShare, SharePoint, Oncore, Veeva

●Governance Documentation: SOPs, Work Instructions, Job Aids, Templates, Trackers

●Study-Specific Documentation: CRFs, CCGs, DVS/ECP, DMP, DTS, Local Lab Conventions, UAT Scripts, Data Review Plans, Listing Specifications

●Global Standards Library

●CDISC training 2023 – CDASH/SDTM implementation

●ICH-GCP guidelines

●21 CFR Part 11 regulations

●FDA BIMO Compliance Program (Section N)

THERAPEUTIC AREAS

●Leukemia Phase I-III

●Lymphoma Phase I-II

●Multiple Myeloma Phase I-IV

●Stem Cell Transplant Phase IV

●Endometrial Cancer Phase I

●Breast Cancer Phase I

●Colorectal Cancer Phase II

●HPV Cancers Phase I/Ib

●Melanoma Phase I

●Prostate Cancer Phase I/II

●Urothelial Cancer Phase I

●Bladder Cancer Phase I

●CNS (Fibromyalgia) Phase III

●CNS (Migraines) Phase III

●Sepsis (Neonates) Phase II

●Type II Diabetes (Mellitus)

●Rare Disease Phase II-III

●Psychiatry Phase 1b-III

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