- Highly experienced Pharmaceutical Technology Management and Programming Professional with significant expertise in SAS Programming, Clinical Data Management, Reporting & Analytics, and Database Development. Background includes pharmaceutical research (pre - clinical and human trials) and insurance industry programming working with startups to large corporate companies.
- Proven ability to manage end-to-end delivery of multiple projects through the full data management lifecycle ensuring consistent data handling and quality in compliance with GCP and GLP regulations.
- Managed clinical data management teams that produced results that were reproducible and cost-efficient.
- Expertise in the SDLC of systems and processes in the facilitation of data collection and extraction projects, as well as change management and corrective actions.
- Reporting background includes extensive use of complex stored procedures, embedded procedures, SQL and SAS.
- Clinical programming and data management roles included experience using TSQL, stored procedures views and base SAS for the import, export and creation of sponsor-required datasets.
Microsoft TSQL: Programming, views, stored procedures, and triggers
Microsoft: SSRS, Reporting Services, Crystal Reports 8.5
SAS Programming: creating datasets to export requirements; edit check programming; proficient in utilization of SAS/ACCESS component
Experience with: VB.NET and C# Programming of applications and enhancement of internal systems Visual Studio 2005, 2008, and 2010 Medidata Rave, Medrio
Minor experience with: Tibco Spotfire visualization product
Sr Clinical Data Manager
- Assist with the creation of Case Report Forms (CRFs) and database design.
- Create and validation of edit checks.
- Creation of study documentation, such as the data management plan, manual review guide and data entry guidelines.
- Oversee data review and query generation for data cleaning practices.
Manager, Clinical Programming
- Responsible for daily operation and creation of sponsor data deliverables, special projects and implementation of reporting capabilities. E mphasis on customizing data management solutions that emphasized transparency, integrity and accountability, as well as speed and accuracy in compliance with GCP standards.
- Managed a clinical data programming team that produced results that were reproducible and cost-efficient.
- Managed a group of three database developers in the creation and generation of client deliverables using internal data transformation engine, SQL and SAS.
- Provided project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, and issue escalation.
- Identified three critical errors within the data transformation engine and effectively remediated those issues.
- Assisted with practice and onboarding of JReview as an integrated review tool with SureSource portal.
- Created ten standard reports with dynamic connection string across different schemas using SQL Server 2012, TSQL.
- Produced numerous adhoc listings using TSQL.
Manager, Reporting & Visualization
- Key member of the management team accountable for leading the expansion and improvement of reporting systems with greater capabilities that better met the needs of our customers in a GCP environment.
- Oversaw client projects including subject tracking, image recognition, image review progress, query status, site reporting needs and workload forecasting.
- Assumed responsibility of ailing IVRS integration programmer group using SSIS and turned around negative customer impression of response times.
- Provided comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs. Ensured timely follow-up and resolution of compliance issues.
- Managed two SQL developers in the generation and creation of reports from eCRF and internal project management system.
- Managed the IVRS integration team during a division re-organization and downsizing while retaining key staff members.
- Established strong communications with Data Operations team, functional leads, project managers and all other stakeholders.
- Implemented proactive quality management plans across multiple projects/programs. Tracked service performance and provided leadership to identify root causes of issues and implement remedial actions.
- Significantly reduced overall error rate for integration programmers by more than 50%.
- Utilized Spotfire for several Phase I medical affairs presentations.
- Created weekly tracking reports for sponsor utilization and metrics tracking.
- Ensured service and quality met agreed upon specifications per the DMP and contract/SOW.
Sr. Manager, Clinical Data Management
- Managed department for end-to-end delivery of data management services for projects, ensuring quality deliverables on time, within budget and to specification
- Sourced, hired, trained and mentored departmental staff.
- Delivered leadership and vision to the team in the areas of project planning, execution, and close-out; communications; and milestone deliverables. Served as primary point of contact for customer on data management deliverables. Highest level accountability for all sponsors and handled escalated issues as needed.
- Corresponded with sponsor data management personnel for audit/defense of data/issue escalation and remediation plans.
- Restructured the department and introduced a Project Data Lead position to a positive benefit to the group.
- Supported data management service delivery with comprehensive process and technical expertise in executing projects.
- Oversaw all data management deliverables for assigned studies.
- Developed justification for staff proposals including breakdown of staff activities to effectively show ROI.
- Implemented an edit check process using SAS.
- Implemented a ticket system for work requests improving response rates by 38%.
- Developed a plan for migration from base SAS to SAS Enterprise Guide.
- Planned and executed the migration from SQL Server .
Manager, Clinical Data Management
- Responsible for review of imaging charter, feedback to EDC/eCRF form build and definition of delivery specifications for receipt of clinical data and submission of clinical data generated from the independent medical for sponsor clinical trials conducted in various therapeutic areas.
- Managed departmental staff of 10 including project data managers and clinical programmers in the creation of data specification, collection and delivery.
- Mentored staff on programming practices for SAS and TSQL. Managed other staff members on coding practices.
- Managed staff in the successful on time delivery of eCRF data to software requirements specifications. Assisted on escalated support issues for eCRF collection and delivery activities.
- Ensured accuracy and consistency of clinical databases by reviewing data and identifying errors/inconsistencies, collaborating with project team to resolve data issues and tracking issues through to resolution. Prepared and validated ad hoc data listings as necessary.
- Implemented usage of SAS and SAS Access OLEDB for delivery creation.
- Served as the primary contact for Data Transfer Specification (DTS). (Cont. P2)
Manager, Clinical Data Management
- Implemented edit check process using SAS against the study deliverables.
- Reviewed and approved study-specific procedures applicable to the department. Responsible for departmental SOPs.
- Implemented the usage of Oracle Life Science Data Hub (LSH) for RECIST studies.
- Coordinated and documented the receipt and processing of electronic or ancillary data received from outside sources including data received from other central laboratories, CROs, or Sponsors.
- Implemented usage of C# .NET as standard programming language for custom software development.
- Generated initial version of project management system using ASP.NET that later evolved into the Clinical Trial Management System (CTMS). Project included the design and creation of the database, store procedures and views utilizing SQL Server 2005.
- Created standard audit trail practice for eCRF databases using a custom trigger on database tables.
- Advised line managers on GCP and GLP programming practices.
- Created CRF collection systems using C# and SQL. Developed a project management system using ASP.NET and SQL.
- Reviewed database specification documents created by study teams including CRF Specifications and Data Validation Specifications (DVS).
- Planned and coordinated database design, development, implementation, maintenance, and user support of clinical systems.
- Provided advanced technical expertise in conjunction with internal and external clients.
- Programmed, tested, and documented databases in accordance with programming standards and validation procedures.
Senior Developer, Information Technology Department
- Led the creation of the Time Phasing application for realization of lab revenue using Visual Basic 6.0 resulting in the capture of an additional $9M in monthly revenues. Project included backend database design, table creation, views and stored procedures.
- Developed a reporting functionality using Crystal Reports 8.5 as a member of the eNotes Intranet application project.
- Designed an FDA Price screen using OLE drag and drop methods with a file explorer format.
- Automated instrument collection methods from Hematology, Urinalysis and Electrophoresis lab equipment.
- Contributed to Y2K remediation of legacy system applications on HP3000 system and PowerHouse 4GL programming environment.
- Provided support to in house Laboratory Information Management System (LIMS) and Metrology systems.
- Developed instrument interfaces and internal systems using Visual Basic 6.0, C#.Net and SQL Server.