NICHOLAS SOSAN
Katy,TX
Summary
Clinical data manager with extensive experience in managing and ensuring accuracy of clinical trial data. Known for collaborative approach and focus on achieving high-quality results. Reliable team player who excels in adapting to changing project needs and effectively utilizing data management tools.
Overview
5
5
years of professional experience
Work History
Clinical Data Manager
Grail Bio
Menlo Park, California
07.2022 - 06.2024
- Developed and maintained trial documentation, ensuring data management guidance and accuracy throughout study lifecycle are followed
- Validated and ensured clinical trial data integrity and accuracy by generating reports and maintaining data integrity
- Monitored data management quality by ensuring database content and documents meet audit standards
- Reviewed and refined CRO-drafted study documents, ensuring data transfer agreements and management plans meet project needs
- Led database lock activities, by ensuring data quality, proper documentation, and inspection readiness for assigned studies
- Collaborated with Statistical Programming, Biostatistics, and Clinical Operations to achieve project deliverables and timelines
- Collaborated with Clinical operations and Biostatistical team in the transferring Clinical Datasets and Bio-samples for analysis
- Provided Data Management guidance and training to CRO's, vendors, and clinical sites; ensured external data sources and clinical study data are accurately captured and incorporated
- Successfully reduced data validation errors by refining data entry and validation processes
- Collaborated with the study team(Medical Monitors, CRAs, Pathologist, CTMs) to conduct comprehensive data reviews, ensuring data accuracy, resolving discrepancies, and supporting timely study milestones
- Utilized LIMS to manage and track clinical samples, ensuring data accuracy and compliance with regulatory standards
- Created and tested Edit checks to ensure accuracy, consistency, and compliance with study protocols and regulatory standards in clinical trial datasets
Clinical Data Manager
Lotus Clinical Research
New Providence, New Jersey
06.2021 - 06.2022
- Developed and implemented discrepancy resolution and data control activities, ensuring high data integrity
- Managed project timelines, achieved milestones with proactive coordination with the entire study team
- Led User Acceptance Testing and contributed to project success by ensuring technical specifications met client needs
- Led study start-up, by approving key documents and cultivated new relationship with third-party vendors
- Led the query management process to address inconsistencies in pain intensity scores and medication usage, ensuring data accuracy and completeness for statistical analysis
- Supported the implementation of new technologies and software tools to enhance data management capabilities and streamline workflows.
- Conducted ongoing assessments of data quality throughout the course of each trial, addressing any issues promptly and effectively.
- Collaborated with the safety team to monitor adverse event data related to post-surgery pain management therapies, ensuring timely reporting and resolution of critical issues
- Communicated with the cross-functional teams, oversaw project scope and lifecycles, ensuring deliverables met quality standards
- Provided advanced project management by prioritizing multiple initiatives and resources, drove departmental efficiencies by wearing many hats and assisting the Clinical operations team
- Acted as a mentor to data management staff and vendors, leading DM processes and system improvements with minimal oversight
- Helped create scope scenarios and negotiated outcomes with study teams while considering the cost and value of different scenarios
Clinical Data Associate
Acelrx Pharmaceuticals
Redwood City, California
03.2019 - 03.2021
- Responsible for protocol evaluation, database design, data capture technology, data review and source documents
- Assisted the Database Administrator with the design of the clinical study database
- Applied my therapeutic knowledge and data management discipline knowledge to ensure database deliverables are consistent, accurate, adherent to the data strategy, and deliver the clinical, statistical, and business demands of the team
- Executed project monitoring and quality oversight of sourcing providers for end-to-end data management activities - from study set up through trial execution through dataset delivery
- Approved key deliverables (i.e., Data quality Delivery Plan, Data Lock Plan, Project Plan, database and observed datasets)
- Ensured that data acquisition, database design and observed dataset requirements are reflective of specific protocols objectives
- Updated, corrected, and reviewed data in the clinical databases based on resolved data queries
- Assisted with resolved data quality issues and updating SOPs and validation processes
- Coordinated with site staff to address queries related to clinical data promptly, minimizing disruptions to study timelines.
- Collaborated with cross-functional teams, fostering strong working relationships for seamless project execution.
- Collaborated with the DM team to develop standard operating procedures for consistent execution of daily tasks across the team.
Education
Business Management
Concordia College
Bronxville, NY05-2016
Skills
- Medical Coding
- IRT integration
- Data integrity
- Data validation
- Database Design
- DMP
- SOPs
- User Acceptance Testing
- Study-Start-up
- EPRO
- Lab Data Review
- Query Management
- Data Review
Therapeutic Areas
- Cardiovascular(Phase I, II, III)
- Oncology(Breat/Colorectal)
- Alzheimer's Disease
- Post surgical pain management
- Respiratory
- Infectious disease
EDC Systems
- Veeva(CDMS,CTMS,TMF)
- Rave
- Medrio
- OCRDC
- Openclinica
- Redcap
- Clindex
- Grail(In-House EDC)
Timeline
Clinical Data Manager
Grail Bio
07.2022 - 06.2024
Clinical Data Manager
Lotus Clinical Research
06.2021 - 06.2022
Clinical Data Associate
Acelrx Pharmaceuticals
03.2019 - 03.2021
Business Management
Concordia College