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Luce Penney - Resume - January 2024 - Updated
Luce Penney - Resume - January 2024 - Updated
[email protected]
276 Blue Hills Parkway, Apt 1, Milton MA 02186
508-740-0071
Experienced DM with over ten years in clinical trials for both lead and support roles.
Broad background in clinical trials database management of phase I/II/III trials for both EDC and paper-
based studies.
Approximately 10 years of experience working in the Pharma industry and 6 years working with CRO.
Therapeutic areas of experience include Oncology: NHL and Adult B cell ALL, Advanced solid tumors,
Lung cancer, Breast cancer, Ovarian cancer, Chronic myelogenous leukemia, Metastatic renal cell
carcinoma; Cardiovascular: stents/drug; Allergy/Immunology: asthma drug; Endocrine/Metabolism:
hypercholesterolemia.
Knowledge and use of RECIST, version 1.1, Lugano Criteria for Response Assessment
Supported achieving database lock within the scheduled timeline with an exceptional database audit
rating for last project.
Writing and maintaining study related guidelines
Experienced in NDA submission preparedness and submission
Experience in paper-based and EDC data management systems (Medidata Rave and Oracle Inform)
Experience with eClinical elluminate, and other CDM reporting tools.
Experience working with central and specialty labs/vendors.
Working knowledge of medical terminology and medical coding dictionaries including MedDRA and
WHO Drug
Familiarity with applicable government regulations such as GCP, ICH and FDA requirements as
applicable for Clinical Data Management.
Able to manage multiple initiatives and shifting priorities.
Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic
team environment.
Experience with FDA submission using CDISC starndards, including clinical submissions for RMAT
designation.
Clinical Data Manager (Contractor)
February 2021 – December 2023
Perform thorough development testing of the eCRF prior to deployment, inclusive of creating User
Acceptance Test (UAT) Plans, Test Scripts and execute testing as applicable.
Participate in study document reviews, e.g. clinical study protocols, statistical analysis plans, Mock
Tables, Figures and Listings (TFL) shells.
Assumed the ability to meet the requirements of a CDA II with a high degree of proficiency and autonomy
Took responsibility for specific tasks on projects,
Facilitated training /QC for new team members
Responsible for quality control of queries created by team members
Served as a liaison between intercontinental project teams in resolving data discrepancies
Reviewed the Data Validation Specification prepared by the Technical Analyst in GTS
Utilized current study documentation including protocol, Case Report Forms (CRFs), Cleaning guidelines,
etc
Generated and close queries or apply self-evident corrections to the data according to the relevant
guidelines
Initiated the running of study specific programs
Lead on reconciliation of vendor data
Lead on Data Issue Tracking report generated by the sponsor
Conducted in-house data review
Manual and Patient Profile review, issued queries
Tracked and integrated queries
Updated all relevant tracking system on an ongoing basis
Kept Manager informed about work progress and any issues.
Lead data manager in the running of a study drug trial in the Clintrial database
Annotated CRFs for database specs; QC of metadata, test database, and SAS dataset matrix
Developed specifications for five sponsor standard reports
Developed and assisted with Clinical Data Management study documentation including Case Report
Form and CRF Completion Guidelines, database design (annotated CRF), validation specifications and
Data Management Plan
Developed specifications for 5 sponsor standard reports
Generated and integrate both manual and automatic queries for paper and EDC studies
Participated in CRF revision and UAT testing
Created and produced daily reports for the cleaning of the IVRS, EDC and Clintrial systems and provide
weekly compliance reports
Responsible for the execution of subject transfers for 7 EDC studies
Reviewed the submitted CRFs for clarity and completeness; ran outlier listings and validations to ensure
data quality; processed high volume manual review of 2183 subjects in an EDC platform.
Participated in overarching group activities to improve site performance and data collection.
Trained staff on data handling guideline processes and software
Completed quality assurance assignments
Assist lead Data Managers with the writing of study documentations including Case Report Forms and
CRF Completion Guidelines, database design, validation specifications and Data Management Plan
Communicated regularly with cross-functional team members and external vendors via team meetings,
email and conference calls to ensure adherence to all time lines
Experience in reviewing the study protocol, ran data validation edit checks and reviewed data for logic,
consistency and protocol compliance
Performed CRF tracking and data entry including reviewing the data for quality and trends
Based on manual review and database specification, generated queries to 26 sites to ensure that data is
complete in preparation for biostatistics analysis
Performed data cleaning and correction which also includes Database Quality Control which resulted in a
zero-error rate.
Verified all key safety and efficacy variables for each subject by comparing the CRF data to that contained
in the database
Responsible for Serious Adverse Event Reconciliation by reviewing SAEs to ensure that the information in
the clinical trial database matches the safety database
Incorporated laboratory (QCAs) and other external (ECGs) clinical data received from a vendor into the
ClinTrial clinical database
Ensured that all reported medical conditions are coded by the Safety Specialist prior to closing and
locking the clinical trial database
Successfully locked the clinical trial database which allowed for the developing and approving of the study
report
Maintained knowledge of data management standards by regularly reviewing internal SOP’s, FDA/ICH
guidelines, GCP’s and regulatory compliance