Summary

Overview

Work History

Education

Skills

Timeline

Catherine M. Lopez

South San Francisco,CA

Summary

Over 13 years of Clinical Data Management experience, specializing in developing and implementing case report form designs utilizing CDISC/CDASH to standardize data collection methods, and ensure compliance with regulatory requirements. Proficient in all facets of clinical data and protocol requirements. Strength in effective communication with study management teams to meet deadlines and resolve ongoing issues. Extensive experience in overseeing data management CRO's to ensure high data quality. Experienced in inspection readiness and eTMF filing with a keen eye for detail and adherence to the DIA reference model.

Overview

years of professional experience

Work History

Sr. Manager, Clinical Data Management

Denali Therapeutics

Sr. Clinical Data Manager (Contractor)

Aimmune Therapeutics

09.2017 - Current

Conducting and supporting data reviews.
Submitting queries to vendors.
Following up on query resolution.
Development of data validation specifications and collaboration with clinical programmers to program specifications.
Assisting in review and approval of vendor data management documentation, such as CCGs, Data Management Plans, and Data Validation Plans.

Clinical Data Coordinator III

Medivation

01.2016 - 03.2017

Worked collaboratively with internal and CRO data management staff, CRAs, statistical programmers, and other clinical, regulatory, and project management staff, to meet project deliverables.
Designed Case Report Forms for data collection for clinical studies.
Worked closely with EDC programmers to build data bases for multiple studies.
Performed UAT using test scripts to ensure database is working properly and system edit checks are correctly programmed.
Reviewed prepared portions of the Data Management Plan and CRF completion guidelines.
Created routine reports alongside clinical programmers to track study progress and to ensure quality expectations are met.
Specified and reviewed data listings to identify data quality issues and to validate table contents.
Reviewed clinical data using adhoc retrievals (e.g., SAS Enterprise Guide).
Worked with CRO to query investigational sites regarding omissions, errors or inconsistencies.
Facilitated internal cross-functional meetings.
Maintained electronic and paper files that can be accessed by appropriate personnel.

Clinical Data Associate I

03.2014 - 12.2015

Clinical Data Associate (Contractor)

Gilead Sciences

03.2013 - 03.2014

Worked collaboratively with; Clinical Programmers, CRA, Statistical Programmers, Biostatisticians, Clinical Operations, Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines for routine to basic clinical data acquisition, quality checking and reporting.
Facilitated data working group meetings to review data collection and subject status.
Managed risks relative to study milestones while discussing data issues and trends identified during the course of data handling and review.
Ensured completeness, correctness and consistency of clinical data and data structure.
Identified, tracked, and resolved basic queries.
Utilized and distributed reports to the study team to track study progress and ensure timelines and quality expectations are met.
Basic knowledge of FDA regulations and familiarity with web-based Electronic Data Capture (EDC) and clinical data management systems.
Worked closely with Regulatory Affairs, Regulatory Operations as well as the SMT to ensure that the correct casebooks are processed and uploaded into a secure electronic environment for archiving prior to an NDA/PMC submission.
Participated in a timeline initiative to assist the data management group with EDC development by improving communication with EDC programmers.

Alternative Funding Specialist (Contractor)

Genentech Access Solutions

12.2012 - 03.2013

Identified and facilitated referrals to financial assistance programs for patients who are under insured or require co-pay assistance.
Provided customer focus support to patients, distributors, and physicians.
Responsible for making outbound calls to patients referred by healthcare providers and case managers.
Responsible for follow-ups on enrollments and re-enrollments.
Responsible for answering inbound calls from patients and healthcare providers and answering general questions about the enrolment process.

Clinical Data Manager

Emphusion LLC

03.2010 - 11.2011

Reviewed and analyzed clinical trial data throughout the study life cycle to ensure data consistency, integrity and accuracy based on project specific guidelines.
Queried data inconsistencies.
Generated and reviewed reports and listings as required for maintaining data integrity.
Responsible for data entry, data transfer and quality assurance.
Executed quality control activities such as preparing and carrying out internal database review, performing visual QC on data loads, performing scanning and tracking QC.
Executed a variety of administrative tasks including but not limited to filing, printing (including DCF printing), and shipping and formatting deliverables.
Provided accurate timely and consistent clinical data to client organizations and internal staff to support business objectives.