Stephen Ola Email & Phone Number

• Develop data management plans and reports, validation procedures and data entry processes.
• Follow standard operating procedures to perform quality control audits.
• Process clinical data by entering records of receipt, verification and entry of information.
• Develop procedures for organizing and filing clinical data to enhance workflow efficiency.
• Tailor data management plans to specific projects to effectively reach deadlines.
• Increase productivity and efficiency by regularly reevaluating processes and technologies.

Rockville, Maryland, United States

• Created clinical data management plans (DMP) and related deliverables and maintained the DMP through the project lifecycle according to study design and requirements
• Reviewed CRO data management plans, CRF completion guidelines and external data transfer specifications.
• Reviewed CRFs to ensure alignment with protocol, led and performed acceptance testing of the eCRF and ensured the database structure met expectations and provided CDM insight to promote effect clinical database.
• Supported vendor qualification for data management, and collaboratively defined the scope of work for functional tasks.
• Led Data Management oversight of data releases/DBLs and ensured timely delivery of data deliverables in accordance with company SOP and ICH GCP.
• Participated and contributed to the Data review and cleaning plan and the development of the data cleaning strategy. Also contributed to providing oversight of the data validation plan and provided data management.

Ewing, New Jersey, United States

• Assisted in completing patients CRF' and questionnaires for research work.
• Followed standard operating procedures to perform quality control audits.
• Analyzed clinical data using statistical tools to identify informational trends.
• Managed Clinical Trial data according to defined protocols and in compliance with data privacy regulations and SOP.
• Performed routine data cleaning activities, verified data entries for accuracy, and resolved any discrepancies.
• Maintained and organized study documentation, including data management plans, CRFs, data dictionaries, and other related documents.

Newton, Massachusetts, United States

• Ensured all new and updated record information is entered accurately and maintained in accordance with TMF storage SOPs, processes and data structure for inspection readiness.
• Assisted with the development and maintenance of the company’s digital records/TMF training materials, SOPs, and guidelines.
• Oversaw overall TMF document quality and completion, including appropriate document filling and maintenance, cross functional document coordination, and TMF tracking and reporting.
• Ensured Clinical trial documentation is consistent with the eTMF specifications, ICH GCP guidelines, regulatory requirements, and applicable SOPs.
• Served as SME for project staff on TMF related questions.