First Name Last Name
Houston,TX
Summary
A senior Clinical Data Manager with over 10years if experience in the Pharmaceutical and healthcare industry, specializing in data management for clinical trials. Demonstrated expertise in designing, implementing, and managing clinical databases, ensuring data integrity, accuracy, and compliance with regulatory standards. Skilled in utilizing advanced data management software and tools. Proficient in leading cross-functional teams, training staff and collaborating with other departments to achieve a seamless research process. Strong problem-solving abilities and adept at streamlining processes to increase efficiency and reduce costs. Committed to advancing clinical research through innovative data management strategies.
Overview
15
15
years of professional experience
Work History
Senior Clinical Data Manager
Fortrea
Remote
05.2022 - Current
- Act as the point of contact for DM activities for multiple trials, provide oversight of data collection and management per regulatory and industry standards.
- Provide oversight of the DM CRO and ensure performance against key indicators.
- Lead the creation of the Data Cleaning and Review Plan and development.
- Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategy.
- Provide DM expertise to trial teams.
- Review CRFs to ensure alignment with protocol; lead and perform user acceptance testing of the eCRF; and ensure database structure meets expectations and provide DM insight to promote effective clinical database structure.
- Define and perform data quality checks and take action to ensure data quality.
- Drive and support vendor qualification for data management, define specify scope of work for functional tasks.
- Provide oversight of DM documentation to ensure inspection readiness and ensure documentation is aligned with best practices.
- Drive DM oversight of data releases and DBLs and ensure timely delivery of data deliverables in accordance with company's SOPs and ICH/GCP.
- Ensure data quality for analysis and reporting; prepare for regulatory filings and inspections.
- Support process improvement and knowledge management by participating in or leading task forces/projects.
Senior Clinical Data Manager
LabCorp
Remote
11.2019 - 05.2022
- Act as the point of contact for DM activities for multiple trials, provide oversight of data collection and management per regulatory and industry standards.
- Provide oversight of the DM CRO and ensure performance against key indicators.
- Lead the creation of the Data Cleaning and Review Plan and development.
- Provide oversight of the data validation plan and provide DM insight to maximize the data validation strategy.
- Provide DM expertise to trial teams.
- Review CRFs to ensure alignment with protocol; lead and perform user acceptance testing of the eCRF; and ensure database structure meets expectations and provide DM insight to promote effective clinical database structure.
- Define and perform data quality checks and take action to ensure data quality.
- Drive and support vendor qualification for data management, define specify scope of work for functional tasks.
- Provide oversight of DM documentation to ensure inspection readiness and ensure documentation is aligned with best practices.
- Drive DM oversight of data releases and DBLs and ensure timely delivery of data deliverables in accordance with company's SOPs and ICH/GCP.
- Ensure data quality for analysis and reporting; prepare for regulatory filings and inspections.
- Support process improvement and knowledge management by participating in or leading task forces/projects.
Clinical Data Manager II
PPD
Remote
03.2016 - 11.2018
- Planned managed, controlled, and performed data processing and management activities for assigned projects.
- Lead assigned data processing and management projects by applying data processing, and management techniques.
- Managed timelines and coordinated activities for assigned projects.
- Lead efforts in developing and maintaining standard database validation checks.
- Defined and monitored clinical trial dataflow and quality control (QC) processes in accordance to corporate Standard Operating Procedures (SOPs).
- Reviewed patient Case Report Forms (CRFs) and Clean the data.
- Test data capture/entry screens.
- Wrote clear queries on missing data and data points failing pre-defined range checks and logical checks.
- Lead efforts in building a standard query library for common database modules.
- Performed QC procedures on assigned database during the trial and additional database closure checks at the end of the study.
- Trained and supervised Data Entry personnel and junior data management personnel on study procedures, study specific handling, and management of trial data.
- Validated and distributed study progress status reports to internal and external study team members.
- Maintained and prepared for final archival of data management documentation relevant to the assigned clinical trials and assisted the corporate archivist in assembling and archiving clinical trial data and study documentation.
Clinical Data Manager I
PPD
Remote
01.2013 - 03.2015
- Assisted clinical data management staff with administrative tasks related to the conduct and implementation of clinical trial data.
- Developed and maintained good communications and working relationships with CDM and project teams.
- Reviewed clinical trial data in accordance with [Global Data Management Plans and applicable standardized data management processes (SOPs, Work Instructions) to identify erroneous, missing, incomplete, or implausible data.
- Managed the development and implementation of new technology/tool.
- Performed reconciliation of the clinical and safety databases.
- Performed reconciliation of central laboratory and/or third party vendor data.
- Involved in the Electronic Data Capture (EDC) clinical database development and user acceptance testing (UAT).
- Assisted with the development of Global Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
Clinical Research Coordinator
Baylor College Of Medicine
01.2009 - 03.2012
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Gathered, processed, and shipped lab specimens.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Followed informed consent processes and maintained records.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Collected, evaluated, and modeled collected data.
- Reviewed referral information and kept track of intakes from various referral sources.
- Monitored unit budget to meet financial objectives for spend rate and funding.
Education
Bachelor of Science - Biology
University of Houston
Houston, TX01.1997
Skills
- HIPAA and HITECH Requirements
- Recruiting and Interviewing
- Accurate Documentation
- Training and Mentoring
- Proficient in Microsoft Office (Word, Excel, Power Point, Outlook, and Access)
- Strong verbal communication
- Excellent Team Player
- Great mentor to CRA
- Proficient in the use of EDC, IVRS, eTMF and CTMS systems
Therapeutic Areas
Oncology:Breast Cancer, Cervical Cancer, Renal Cell Carcinoma, Prostate Cancer, Leukemia, Lung Cancer
Dermatology: Keratitis, Eczema
Respiratory:Asthma, Pneumonia, Influenza
Nervous System: Alzheimer's disease, Parkinson's Disease, Pain, Depression, Multiple Sclerosis
Timeline
Senior Clinical Data Manager
Fortrea
05.2022 - Current
Senior Clinical Data Manager
LabCorp
11.2019 - 05.2022
Clinical Data Manager II
PPD
03.2016 - 11.2018
Clinical Data Manager I
PPD
01.2013 - 03.2015
Clinical Research Coordinator
Baylor College Of Medicine
01.2009 - 03.2012
Bachelor of Science - Biology
University of Houston