Luce Penney

Luce Penney
[email protected]
276 Blue Hills Parkway, Apt 1, Milton MA 02186
508-740-0071
Professional Experience and Skills
 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
 Provide program-level oversight of clinical data management activities.

 Review/Management of DM activities in vendor proposals, budgets and scopes of work
 Collaborate with clinical study teams and vendors to meet project deliverables, including data
acquisition, quality checking and reporting in compliance with GCP, SOPs and regulatory
requirements. Partner with appropriate stakeholders for issue resolution.
 Oversee the development of study-specific CDM documentation such as eCRF specifications, eCRF
completion guidelines, annotated CRFs, edit check specifications, and data management plans –
identifying and mitigating risks to data quality and proper inclusion into the Trial Master File
(eTMF).
 Oversee the activities of CRO DM functional counterparts to ensure adherence to scope of work and
service agreements, and to ensure deliverables are met in accordance with study
milestones/timelines and with quality.
 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.
Senior Clinical Data Manager

April 2017 – Sept 2020
 Work with internal and external Clinical Operations, Research, Data Management and other operational
departments as the main point of contact to ensure accurate, efficient, and complete data collection
 Liaise with Biostatisticians regarding data validations and lock of database including management of
discrepancies
 Review and provide feedback on Protocols, Statistical Analysis Plans and CSRs
 Responsible for working with database build vendor to develop new EDC databases and subsequent
revisions.
 Develop data transfer agreements and specifications with various vendors
 Review eCRF completion guidelines, data management plan (DMP), data validation specifications (DVS,
e.g. edit checks), SAE Reconciliation Plan, Data Cleaning Plan and other DM related documentation in
conjunction with CRO(s)
 Experienced with data cleaning, listings review and query management
 Assist CRO(s) with data cleaning for Interim Analysis, Database lock, and any ad hoc requests
 Review and approve study timelines, monitor timelines and ensure that clinical data management
timelines are met with quality
 Use industry standard conventions, tools, references and process in support of the coding of Medical
History, Adverse Events and ConMeds/ConProcs
 Ensures all DM procedures are executed with a high attention to detail, accuracy and timelines
 Co-create and review DM SOPs and Work Instructions in accordance with current GCP and ICH
guidelines including FDA
 Supervise DM support staff
 Ensure adherence to Data Management standards.
 Other duties as assigned
SAE Reconciliation Specialist (Contractor)

November 2016 – April 2017
 Perform clinical data review and SAE reconciliation
 Communicate regularly with cross functional team to ensure compliance with SAE reconciliation
 Interact and monitor progress of CRO SAE reconciliation activities
 Train employees on SAE reconciliation process.
 Participate in regular team meetings and provide input when appropriate
Lead Clinical Data Manager

June 2015 – October 2016
 Serve as primary point of contact for customer on data management deliverables
 Work closely with database developer in design and testing of clinical database
 Use data validation specifications document to perform thorough UAT of programmed edit checks
 Develop study documentation including Data Management Plan, CRF Completion Guidelines and SAE
Reconciliation guidelines
 Coordinate data reviews, external data entry and query resolution, adverse event and medication coding,
SAE reconciliation
 Participate in protocol review and CRF design
 Communicate and coordinate data management activities with project teams to ensure completion of all
timelines and study-related task
 Monitor workflows and track progress for completion of task
 Prepare study metric reports for use by the study team
 Represent Merrimack in interactions with external vendors
 Review contracts as appropriate
 Oversee CRO work on data management activities on assigned outsource studies
 Work with all external vendors to establish data transfer agreements and to reconcile data to ensure data
consistency
 Ensure data management activities are conducted in accordance with internal SOPs, GCP, GCMP and all
regulatory requirements
Clinical Data Manager (started as contractor then converted perm)
November 2012 – June 2015
Provide data management oversight of CRO for outsourced activities such as CRF development, database set-
up activities, data validation process, medical coding and SAE reconciliation. Participate as well as led data
management data review activities. Cleaning activities include listing review and external data reconciliation
and ensuring completion of all activities leading to the study database lock. Additional key responsibility is
assurance of consistency of data collection and data standards across multiple projects and systems.
 Review and finalize Clinical Data Management study documentation including CRF Completion
Guidelines, Data Management Plans, Study-specific EDC Training documents, and SOPs
 Oversight of all data management study activities including tracking of data entry and query resolution,
data validation and review, query processing and resolution, adverse event and medication coding, SAE
reconciliation, integration and reconciliation of external electronic data with clinical database, and
preparation of study tracking and metric reports for use by the study team
 Participate in protocol review
 DM liaison with cross-functional team members including CTMs, Sites, and CRAs, as well as external
vendors to ensure completion of all timelines and study-related tasks
 Provide additional data management support to functional team members
 Serve as liaison in managing Medidata RAVE account activations
 Ensure compliance with department procedures
Clinical Data Analyst II, (Contractor)

September 2011 – November 2012
 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.
Clinical Data Manager, Boston MA

June 2010 – Sept 2011
 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
Associate Clinical Data Manager, Boston MA

May 2006 – June 2010
 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
Education/ Certifications/ Publications / Professional Affiliations
Emmanuel College, Boston MA, B.A. In Economics 1995

Luce Penney - Resume - January 2024 - Updated

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Professional Experience and Skills

 Provide program-level oversight of clinical data management activities.

Senior Clinical Data Manager

SAE Reconciliation Specialist (Contractor)

Lead Clinical Data Manager

Clinical Data Analyst II, (Contractor)

Clinical Data Manager, Boston MA

Associate Clinical Data Manager, Boston MA

Education/ Certifications/ Publications / Professional Affiliations

Emmanuel College, Boston MA, B.A. In Economics 1995

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