Summary
Overview
Work History
Education
Skills
Professional Development
Therapeutic Experience And Expertise
Clinical Trial Experience
Personal Information
Computer Experience
Timeline
Generic

Laura Blaskowitz-Bantz

Wilmington,NC

Summary

Skilled clinical data manager with strong background in managing and analyzing complex datasets for clinical trials. Expertise in ensuring data integrity, regulatory compliance, and process optimization. Known for collaborative approach, adaptability, and consistent delivery of impactful results. Proficient in data management software, database design, and team leadership.

Overview

19
19
years of professional experience

Work History

Sr Clinical Data Manger

Moderna, Contractor
07.2024 - Current
  • Perform data management oversight activities in support of Moderna’s clinical studies; oversee the activities of DM counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with quality.
  • Perform thorough development testing of the electronic Diary and eCRF prior to deployment, inclusive of User Acceptance Test (UAT) Plans, Test Scripts and execute testing applicable.
  • Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review and reporting in compliance with GCP, SOPs and regulatory requirements.
  • Participate in the development of all Data Management documentation including the electronic Diary Specifications CRF, Data Management Plan, CRF Completion Guidelines, Data Validation Specification, Data Transfer Specifications, etc.
  • Manage clinical trial data through review, cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements, especially as it pertains to electronic Diary data collection and handling.
  • Performs oversight of third-party clinical data vendors (i.e. electronic diary, clinical laboratory).
  • Review data analysis listings and report on performance and quality; review clinical data within studies and across for trend analysis.
  • Collaborate with clinical study team members and lead the Cross-Functional Data Review for clinical studies.
  • Coordinated with statistical programmers to ensure timely generation of analysis-ready datasets for clinical study reports.

CLINICAL DATA TEAM LEAD

PPD
10.2021 - Current
  • Acted as the clinical data team lead for one or more projects or to provide support to the clinical data team lead
  • Lead all data management activities for individual, limited volume/complexity studies with support from senior team members
  • Acted as an interdepartmental and client liaison for all DM study activities
  • Applied relevant components of the project protocol to daily tasks and directed others on how to apply to their daily tasks
  • Acted as a liaison to the PM and/or client as required and communicated with management regarding all data management (DM) activities within their studies
  • Developed and maintained data management project documentation files; performed independent reviews of data management deliverables following documented CDM guidelines
  • Developed and delivered study specific training for DM project staff
  • Produced project-specific status reports for management, PM and/or clients on a regular basis
  • Monitored study metrics


  • Mentored junior level staff on all associated tasks within a study
  • Assisted with the administrative and financial management of allocated projects
  • Performed all assigned data management activities independently and efficiently, with attention to quality

ASSOCIATE CLINICAL TEAM LEAD

PPD
10.2020 - 10.2021
  • Acted as the assistant clinical data team lead for one or more projects supporting the clinical data team lead by performing assigned tasks in study set up, data cleaning, database close-out and other associated tasks
  • Applied relevant components of the project protocol to daily tasks with guidance
  • Delivered study specific training to junior associates for assigned projects
  • Coordinated data cleaning tasks and delegates to appropriate data management staff to ensure quality standards are maintained and project deliverable timelines are met
  • Performed specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development
  • Monitored for risks to deadlines and escalates appropriately
  • Created and maintained data management project documentation
  • Participated in team and client meetings and supports the clinical data team lead with risk management on allocated projects
  • Provided input into project forecasting of hours and identification of resource requirements
  • Monitored study metrics and runs project-specific status reports for management
  • Reviewed data management deliverables for allocated projects following documented guidelines
  • Produced project-specific status reports for management, PM and/or clients on a regular basis

SITE PAYMENTS SPECIALIST II

PPD
01.2019 - 10.2020
  • Managed payments for four protocols
  • Served as the primary contact for the study team and investigative sites
  • Provided study management, ensuring that individual project targets were met, and services were provided according to the highest quality standards, policies and procedures
  • Escalated project risks appropriately
  • Analyzed and interpreted various financial reports and monitors project finances
  • Trained study teams on site payment processes, including setting expectations around site payments' requirements and deliverables
  • Generated reports for study-level KPIs and metrics; evaluated and interpreted data
  • Escalated performance issues to management
  • Attended internal team meetings and provided updates on payment statuses
  • Managed escalations (project team, site and sponsor) regarding payment issues
  • Generated payments in accordance with procedural documents and site contracts
  • Built and entered budgets and site visit templates; worked on transparency reporting; performed study reconciliations; managed and maintained investigator funds tracker for studies transitioned to site payments
  • Reviewed and approved payments, budgets, reconciliations, etc., in accordance with procedural documents and site contracts
  • Mentored and trained junior team members

PRINCIPAL SITE PAYMENT COORDINATOR

PPD
05.2018 - 01.2019
  • Reviewed and approved payments, budgets, reconciliations, etc., in accordance with procedural documents and site contracts
  • Compiled data from multiple sources to generate payments to sites in accordance with procedural documents
  • Ensured adherence to country-specific regulations which affect and impact ability to pay
  • Managed payment responsibilities and workflow to meet contracted timelines and project deliverables
  • Managed escalations (project team, site and sponsor) regarding payment issues and resolves payment-related findings
  • Escalated project risks appropriately
  • Trained study teams on site payment processes, including setting expectations around site payments' requirements and deliverables
  • Processed investigator payments in middleware and financial system; manage refunds, credit notes, late payment fees, pre-payments or investigator meeting reimbursements
  • Built and entered budgets and SVTs; worked on transparency reporting; performed study reconciliations; managed and maintained investigator funds tracker for studies transitioned to site payments
  • Trained/mentored junior team members

SENIOR SITE PAYMENTS COORDINATOR

PPD
09.2016 - 05.2018
  • Responsible for payments for multiple study sites
  • Generated payments to sites in accordance with procedural documents, site contracts and country-specific regulations
  • Built and managed relationships with internal study teams and investigative sites
  • Trained and mentored junior staff

OPERATIONS MANAGER

Bank of America
10.2007 - 09.2016
  • Responsible for the operational excellence of a high-volume banking center, from cash flow to new accounts and everything in-between
  • Ensured adherence to policy and procedure and educated associates appropriately
  • Identified risks and created action plans that achieved results
  • Managed and coached a team of tellers and sellers to exceed referral and sales goals
  • Developed rapport with associates to create an atmosphere of success in the banking center
  • Found solutions for customers in a timely, professional and friendly manner
  • Developed lasting, important relationships with clients

EDITOR

Breeze Newspapers
07.2006 - 09.2007
  • Established a positive relationship with a variety of customers
  • Met demanding deadlines
  • Created layouts for a 38-page weekly paper in an arts-oriented community
  • Trained new reporters and delegated assignments to reporters
  • Kept website updated with breaking news, events calendar and reader-submitted photos
  • Wrote compelling articles covering a variety of topics

Education

M.A. - English Literature

Winthrop University
Rock Hill, SC
05.2006

B.A. - English

College of Charleston
Charleston, SC
05.2003

Skills

  • Database development and testing
  • Query development
  • Data cleaning
  • Electronic data capture
  • Data reconciliation
  • Data query management
  • Effective communication

Professional Development

  • Training while employed at PPD is available upon request.
  • English literature classes with focus on a M.A. in English, Winthrop University, Rock Hill, SC, USA 48 credit hours completed.
  • General education classes with focus on a B.A. in English, College of Charleston, Charleston, SC, USA, 45 credit hours completed.

Therapeutic Experience And Expertise

  • Endocrinology/Metabolic: Propionic Acidemia, Methylmalonic Acidemia
  • Genitourinary: Chronic Kidney Disease
  • Hematology: Anemia
  • Infectious Disease: Rabies
  • Oncology: Non-Small cell lung cancer
  • Other Areas of Expertise: Renal Failure
  • Respiratory: Asthma, seasonal allergic rhinitis (SAR)

Clinical Trial Experience

  • Endocrinology/Metabolic: A Global, Phase 1/2, Open-label, Dose Optimization Study to Evaluate the Safety, Pharmacodynamics, and Pharmacokinetics of Therapeutic Agent in Participants with Propionic Acidemia.
  • Endocrinology/Metabolic: A Global, Phase 1/2, Open-Label, Dose Optimization Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Therapeutic Agent in Participants with Isolated Methylmalonic Acidemia Due to Methylmalonyl-CoA Mutase Deficiency.
  • Infectious Disease: A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of Therapeutic Agent in Adults Aged 18 Years and Older.
  • Hematology/Genitourinary: A Phase 3 randomized, open-label, active-controlled, parallel-group, multicenter, event driven study in dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of XXX compared to recombinant human erythropoietin, following a switch from erythropoietin-stimulating agents.
  • Hematology/Genitourinary: A Phase 3 randomized, open-label, active-controlled, parallel-group, multicenter, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of XXX compared to XXX.
  • Hematology: Genitourinary: A 52-week open-label, randomized, active-controlled, parallel-group, multi-center study to evaluate the efficacy and safety of XXX compared to recombinant human erythropoietin in subjects with anemia associated with chronic kidney disease who are initiating dialysis.
  • Genitourinary: A Phase 3, prospective, multicenter, double-blind, randomized, active control study to demonstrate the safety and effectiveness of XXX in preventing catheter-related bloodstream infections in subjects receiving hemodialysis therapy as treatment for end stage renal disease.
  • Infections/Parasitic Disease: A Phase 2b randomized blinded study to evaluate XXX compared to human rabies Immune Globulin in Post Exposure Prophylaxis of Rabies in adults with different rabies exposure risks.
  • Oncology: A master protocol of phase II studies of XXX in advanced NSCLC: XXX as maintenance after induction chemotherapy or as first line treatment, alone or in combination of standard of care therapies.
  • Respiratory: A 52-Week double-blind, placebo-controlled, parallel-group efficacy and safety study of XXX, subcutaneous dosing in patients with uncontrolled asthma and elevated blood eosinophils.
  • Respiratory: A randomized, single-blind, parallel-group, placebo-controlled, multidose study comparing the therapeutic equivalence of XXX inhaler and XXX inhaler, each delivering XXX in adult subjects with asthma.
  • Respiratory: A double-blind, randomized, parallel-group seasonal allergic rhinitis (SAR) study to evaluate the efficacy, safety and tolerability XXX compared with placebo and individual monotherapy formulations in adult and adolescent subjects.

Personal Information

Title: Clinical Data Team Lead

Computer Experience

  • MS Office: Word, Excel, PowerPoint, Windows OS
  • CTMS
  • EDC: Medidata Rave

Timeline

Sr Clinical Data Manger

Moderna, Contractor
07.2024 - Current

CLINICAL DATA TEAM LEAD

PPD
10.2021 - Current

ASSOCIATE CLINICAL TEAM LEAD

PPD
10.2020 - 10.2021

SITE PAYMENTS SPECIALIST II

PPD
01.2019 - 10.2020

PRINCIPAL SITE PAYMENT COORDINATOR

PPD
05.2018 - 01.2019

SENIOR SITE PAYMENTS COORDINATOR

PPD
09.2016 - 05.2018

OPERATIONS MANAGER

Bank of America
10.2007 - 09.2016

EDITOR

Breeze Newspapers
07.2006 - 09.2007

B.A. - English

College of Charleston

M.A. - English Literature

Winthrop University
Laura Blaskowitz-Bantz