Salome Perryman
Missouri City
Summary
Dynamic Senior Clinical Data Manager with extensive experience at LabCorp, excelling in data management and client relationship development. Proven track record in enhancing data quality and compliance, while leading teams to deliver on-time, high-quality results. Skilled in statistical analysis and effective communication, driving successful project outcomes in clinical trials.
Overview
10
10
years of professional experience
Work History
Senior Clinical Data Manager
Fortrea
Houston
05.2023 - Current
- Oversee the technical performance of the staff on achieving client satisfaction through delivery of quality data, on-time and on-budget
- Assist with the development execution of training programs and ensure staff are trained and adhere to project-specific, global, global, standardized data management processes
- Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary
- Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities
- Review literature and research technologies/procedures for improving global data management practices
- Manage utilization and billability of staff, planning for resource allocation/recruitment based on individual skills, competencies and availability
- Create action plans to address staff quality and performance issues identified by clients, via client satisfaction surveys, and/or from core project team feedback
- Support development of global, harmonized SOPs and specific quality processes and procedures for data management activities
- Previously LabCorp
Senior Clinical Data Manager
LabCorp
Houston
11.2022 - 04.2023
- Oversee the technical performance of the staff on achieving client satisfaction through delivery of quality data, on-time and on-budget
- Assist with the development execution of training programs and ensure staff are trained and adhere to project-specific, global, standardized data management processes
- Develop and maintain strategic client relationships and receive client satisfaction surveys and implement appropriate action plans as necessary
- Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities
- Review literature and research technologies/procedures for improving global data management practices
- Manage utilization and billability of staff, planning for resource allocation/recruitment based on individual skills, competencies and availability
- Create action plans to address staff quality and performance issues identified by clients, via client satisfaction surveys, and/or from core project team feedback
- Support development of global, harmonized SOPs and specific quality processes and procedures for data management activities
Clinic Data Manager III
PPD
Houston
01.2019 - 11.2022
- Oversaw data operations tasks from study start-up to database lock, to produce a clean and analyzable database
- Documented all activities adequately for all assigned studies according to SOPs
- Lead QC activities such as initiating the documentation, maintaining document management systems, coordinating, and ensuring contributions from relevant functions, requesting a timely QC of the documentation, informed relevant functions of results, and ensured proper communication between functions, QC manager
- Provided leadership to Operations team
- Liaised with cross functional lines as appropriate
- Developed study specific eCRFs, data consistency checks based on Medical Standards, Clinical Study Protocol, and input from the study team
- Planned and tracked data contributions of specialized functions typically used for early clinical development activities
- Established data management best practices for data generated in relevant research activities.
- Was responsible for creation of DMP (Data Management Plan) and Edit Checks Specifications, Edit Checks Testing and Validation for both Paper and EDC studies such as AGIIS (IVRS/IWRS), CAT, UAT and DTD Testing, Reports, Review and Validation
- Developed, generated, and analyzed project progress and metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and Sponsor
Clinical Data Manager II
PPD
Houston
04.2017 - 01.2019
- Managed queries on assigned clinical studies
- Completed database cleaning and database lock, and assisted Trial biostatisticians with analysis file creation and statistical analyses in Designing CRF, CRF completion guidelines and database user requirements
- Ensured DM documents are filed per company Standard Operating Procedures (SOP) in study TMF
- Ensured data system compliance by following established guidelines of regulatory authorities
- Performed data cleaning/reconciliation activities as specified in company procedural documents and study-specific Data Management (DM) documents
- Managed study through these phases in a timely and professional manner while adhering to the established clinical trial and regulatory standards and the financial constrictions
- Generated and delivered reports to study team members
- Worked with vendors such as central laboratories in support of timelines and data-related deliverables
- Coordinated the archiving of study databases and related documents
Clinical Data Manager I
Worldwide Clinicals
Houston
10.2015 - 04.2017
- Ensured the development and design of data collection forms are in accordance with study protocol and established standards
- Managed review of listings within Clinical Data Management (CDM) for quality, content, format, and output
- Identified and defined priorities and timeline issues
- Monitored the overall study progress daily, weekly, and proactively developed or adjusted plans as needed to achieve targets
- Identified and defined priorities and timeline issues
- Maintained project tracking database
- Coordinated data validation activities
- Performed user acceptance testing of the database
- Designed electronic Case Report Forms (eCRFs) for study start-ups
- Participated in the development and implementation of department standards and documents, and other data management, departmental activities as needed
- Performed and Managed data entry, database design, verification, and validation activities within data management group and among various sources of clinical data
Education
Master of Science (MSc) - Innovation Management and Entrepreneurship
Middlesex University
London, United KingdomBachelor of Science (B.Sc.) - Business Information system and Information Technology
Middlesex University
London, United KingdomAssociate of Applied Science - Nursing
Nursing Bridges Institute
Houston, Texas, United States of AmericaSkills
- Data management
- Clinical trial oversight
- Statistical analysis
- Database design
- Quality control
- Resource allocation
- Vendor coordination
- Project forecasting
- Compliance management
- Business development
- Effective communication
- Client relationship management
- Problem solving
- Team leadership
- Attention to detail
- Clinical study protocols
- Data quality control
- Data standardization
- Electronic data capture
- Data monitoring
- Data privacy
- Data migration
- Data backup procedures
- Data reconciliation
- Data storage management
- Database development
- Data entry supervision
- Data reporting
- Data analysis tools
- Clinical trial design
- Data mapping
- Study documentation
- Data validation techniques
- ICH-gCP guidelines
- Data integration
- Data query management
- Oracle clinical
- FDA regulations
- Data security
- Data cleaning
- Clinical data management
- Data governance
- Medidata rave
- Operational planning
- Multitasking
- Study reporting
Language Capabilities
English
Systems Experience
iMedidata - 8 Years
IBM - 2 Years
Veeva EDC - 3 Years
Oracle Clinical -1 Year
Therapeutic Experience
- Oncology: (Lymphoma, Prostate Cancer, Breast Cancer, Urothelial Carcinomas : Low-Grade Upper Tract Urothelial Carcinoma (Phase II)
- Pulmonology: Asthma, Chronic Obstruction pulmonary disease (COPD) and Pulmonary fibrosis
- Rare disease: Fibro Dysplasia ossificans Progressive (FOB)
- CNS: Parkinson, Alzheimer disease and Neurofibromatosis
- Endocrinology/Metabolic Disorders: Type 1 Diabetes Mellitus - Nocturnal hypoglycemia Prevention (Phase II)
- Hematology Onocology : AML, MDS, CMML (Phase II)
- Dermatology : Chronic Pruritus (Phase II)
Timeline
Senior Clinical Data Manager
Fortrea
05.2023 - Current
Senior Clinical Data Manager
LabCorp
11.2022 - 04.2023
Clinic Data Manager III
PPD
01.2019 - 11.2022
Clinical Data Manager II
PPD
04.2017 - 01.2019
Clinical Data Manager I
Worldwide Clinicals
10.2015 - 04.2017
Master of Science (MSc) - Innovation Management and Entrepreneurship
Middlesex University
Bachelor of Science (B.Sc.) - Business Information system and Information Technology
Middlesex University
Associate of Applied Science - Nursing
Nursing Bridges Institute