Danielle S. Email & Phone Number

New York, United States

Designated as Central Lab Medical Writer on global Phase I, II, and III clinical trials to oversee safety testing, microbiology diagnostics, and biomarker analysis. - Lead the development, revision and maintenance of complex clinical study protocols, clinical study reports, and other medical/technical documents; responsible for authoring and finalizing.

Designated as Central Lab Lead on global Phase I, II, and III clinical trials to oversee safety testing, microbiology diagnostics, and biomarker analysis. Partnered with clients to develop project strategy to ensure established objectives and timelines are met. Designed and finalized study scope of work documents and protocol testing summaries. Conducted.

• Working closely with the technology, product development and software teams to building workflow requirements, product requirements and coordinate technology implementation and commercialization
• Developing and updating procedures such as Standard Operating Procedures (SOPs), Work Instructions, Training Toolkits (guides, certifications, etc) to roll out new technology and/or improve processes
• Ensure processes and procedures across all teams at all BioTel Research locations are consistently written, documented and followed
• Working with the cross-functional team to manage CAPAs and process improvements along with coordinating training and documentation
• Providing regular reporting to executive team on process improvement/CAPA and product launch initiatives, timelines, goals, achievements
• Overseeing assigned responsibilities and ensuring processes are appropriately followed and timelines are met

• Manage project workload and providing feedback to the Director, Data Management regarding resource forecasts for the group, as well as project assignments
• Provide detailed operational input into project planning focusing on Data Transfer Specifications, Study Analysis Platform Setup and other Data Management concerns
• Work directly with sponsors on definition and/or review of Data Transfer Specifications in conjunction with other data management personnel for timely completion
• Manage cross-functional teams for timely completion of Study Analysis Platform Setup
• Manage the Data Management department CAPA and Deviation work queue from creation to closure working with all departments and helping implement new processes/documentation when applicable
• Support implementation of technology-enabled processes, working in partnership with other internal groups

United States

- Act as the primary contact and imaging lead with the client from startup through close-out of a project - Develop and implement project plans and timelines via internal and external kick-off meetings and ensure agreement by parties involved- Develop presentations for Investigator Meetings and Kick Off Meetings and travel independently to present at these.

- Identify and implement solutions for business needs utilizing Lean Six Sigma DMAIC methodology- Work with business units to determine key metrics and current performance - Conduct root cause analysis- Create current day process flows - Create future state process flows- High use of Microsoft Excel for data analysis- Utilize project plan to continue.

- Development support for System/Tool builds for Enterprise Repair as it related to reporting, efficiency gains and assist with every day functions. - Worked closely with Developers to provide the best solution through root cause analysis and 5 whys- Coordinate and conduct UAT for enhancements and system/tool builds- Assisted with build out of Jira work.

- Root Cause Analysis of customer feedback through 5 Why's.Mapping NPS metrics to Operational Metrics to help analyze areas of focus. - Build out detailed reporting specific to feedback outside of Medallia to best fit the business needs- Managed callback team program to ensure all feedback was addressed and logged properly in Medallia. Structured.

Bachelor'S Degree, Fine And Studio Arts

Associate Of Arts - Aa, Painting