O A
Katy,Texas
Summary
Knowledgeable Data Manager bringing [Number] years and thorough, hands-on approach to analysis and handling of data-retention systems. Successful in pinpointing and addressing complex information management flaws. Expert navigation of complex data storage, disposal and security guidelines to maintain compliance with confidentiality mandates. Critical qualitative analytical support and testing to resolve troublesome content access concerns.
Overview
7
7
years of professional experience
1
1
Certificate
Work History
Lead Clinical Data Manager
Opp[p
Nyack, NY
02.2019 - Current
- Collaborate and communicate effectively with sponsors, third-party vendors (e.g., IRT, central and specialty labs, patient diaries), and internal teams regarding trial data management matters. Provide updates on the production of data status, progress of report listings, and other necessary outputs throughout the trials.
• Strategize, execute, and supervise the development of electronic Case Report Forms (eCRF) and edit check specifications. Additionally, oversee the execution of User Acceptance Testing per the protocol.
• Assume a key role in both authoring and thorough review reviewing critical data management documents for approval, covering aspects like eCRF Completion Guidelines, coding guidelines, data management plans, edit check specifications, project timelines, SAE reconciliation plans, and more.
• Facilitate the data integration process between EDC and vendor databases, developing precise data integration specifications and ensuring seamless integration between the two databases.
• Act as the primary data management lead across assigned studies within the cross-functional team and collaborate effectively with Sponsor data management.
• Oversee and execute ongoing data management activities, encompassing eCRF review, query generation and reconciliation of external data transfer, SAE reconciliation, data listing generation, and the production of CDM summary reports (e.g., metrics) within the stipulated study timelines.
• Support medical coding of data using MedDRA & WHODrug dictionaries, ensuring that clinical data management activities are executed in strict compliance with regulatory authority requirements and Good Clinical Practices (GCP).
• Ensured strict adherence to Data Management timelines and managed budget to achieve sponsor and team goals.
• Contribute valuable insights to the preparation of investigator meeting materials and deliver data management instructions during investigator meetings, aligning with business needs and management decisions.
• Conduct training sessions for new staff, including CDMs, senior CDMs, and new Lead CDMs. Additionally, provide support and willingly take on various roles within the team when needed.
• Enhance data integrity and streamline clinical data management by meticulously implementing CDASH standards and overseeing the production or review of Case Report Form (CRF) specifications.
• Deliver extensive support to the Data Safety Monitoring Board and various vendors, inclusive of training sessions for Investigators, site staff, and the client's internal teams - Self-motivated, with a strong sense of personal responsibility.
- Skilled at working independently and collaboratively in a team environment.
- Cultivated interpersonal skills by building positive relationships with others.
- Participated in team projects, demonstrating an ability to work collaboratively and effectively.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Managed time efficiently in order to complete all tasks within deadlines.
Clinical Data Manager
Ooooo
Santa Rosa, NM
11.2016 - 01.2019
- • Provide data management expertise and support to internal project teams, and Clinical Research Organizations (CROs).
• Contributed to study start-up activities, including but not limited to eCRF design, User Acceptance Testing (UAT), and review of edit checks, query logic, and data validations.
• Contributed to continuous data management efforts such as reconciliations and initiatives focused on enhancing data quality through thorough cleaning processes to ensure consistency with the protocol and database.
• Contributed to the meticulous review of various data management-related documents for approval, including but not limited to the data management plan, CRF Completion Guidelines, edit check specifications, coding guidelines, SAE reconciliation plan, and vendor data transfer agreements.
• Served as the primary liaison with third-party data vendors and EDC vendors.
• Documented and addressed any errors, omissions, or inconsistencies found during data review and worked with the project team both internal and external to resolve data management-related issues as needed.
• Lead and ensure appropriate procedures are followed for database lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and/or final database lock.
• Collaborated effectively with Clinical, Biostatistics, Clinical Scientists, and Project Management teams to proactively identify and address data-related challenges, ensuring seamless troubleshooting and problem resolution.
• Engaged in the preparation and presentation of data as needed, while also taking the lead in organizing regular data review meetings within a cross-functional team.
• Ensured strict adherence to Data Management timelines and budgetary constraints.
• Actively contribute to internal team meetings, offering insightful data management updates for assigned studies. - Streamlined data management workflows for increased efficiency and reduced processing time.
- Enhanced data accuracy by implementing robust data validation and quality control processes.
Education
Bachelor of Science - Business Administration And Management
02.2025
Skills
- Database Management, Data Quality Assurance, Clinical Data Analysis, Protocol Compliance
Data Validation, Electronic Data Capture (EDC), Clinical Data Entry, Database Design and Maintenance
Data Migration, Clinical Trial Data Management, Regulatory Compliance, Team Collaboration
Statistical Analysis, Technology Integration, SOP (Standard Operating Procedures) Adherence
Certification
City specialist
Timeline
Lead Clinical Data Manager - Opp[p
02.2019 - Current
Clinical Data Manager - Ooooo
11.2016 - 01.2019
Ghhh - Bachelor of Science, Business Administration And Management