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 documentation.- Interpret, understand and contribute to the scientific details of the protocol/technical documentation; identify and resolve gaps to ensure client satisfaction.- Serve as a subject-matter expert (SME) for medical documentation utilized throughout the study lifecycle.- Lead, initiate and manage multiple rounds of document review.- Liaise and drive timely collaboration between key stakeholders to ensure technical documentation meet high quality standards and aligns with business process.- Lead client interactions in support of medical/technical documentation associated with studies.- Participate in client interactions during study start-up activities and/or during study amendment process.- Resolve challenges and build consensus between all cross-functional groups and collaborators in a timely manner.- Ensure high quality documentation that meets regulatory requirements; proofread and copy-edit content as needed.- Identify, develop and execute continuous improvement projects associated with technical documentation; leverage industry standards to drive best in class technical documentation.- Maintain a general working knowledge of Food & Drug Administration (FDA), Medical & Healthcare Regulatory Agency (MHRA), New York State Department of Health (NYSDOH), Good Clinical Practice (GCP), ICH and other pertinent regulations.- Participate in process improvement by developing methods to improve productivity, service, quality, cost savings, policies & procedures.- Aid in the development of Standard Operating Procedures and associated training.

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 investigator meetings via teleconference or in-person meetings. Implemented laboratory testing and validated study structure in accordance with protocols.Key highlights to date include:- Served as Project Manager for largest client in company portfolio and provided specialized training to project team oncomplex client requirements.- Managed seven (7) clinical research studies with individual values of up to $4M, resulting in total of $10M.- Presented monthly project status updates and metrics to global client and internal management teams, providing insights into trial progression and preliminary results.

• 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• Managing workload, forecasting, and team metrics• Providing support for and participating in internal and external meetings to present on operational capabilities and process changes • Supporting creation and reporting of Metrics for both internal performance, sponsor-facing and reader performance, as required• Supporting client audits, as needed

• 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• Manage responses to audit findings, both internal and external• Produce and Analyze Data Management KPI's

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 meetings when required- Revenue and forecasting management, tracking and submittal to meet departmental metric and goals- Coordinate cross-functional teams to ensure efficient processing of project requirements- Conduct routine client teleconferences and generate and maintain accurate records and meeting minutes in accordance with regulatory guidelines- Updating of budgets and contracts and gaining management approvals for Change Requests- Generate and Maintain Patient and Site Tracking Reports via MS Excel and Internal system Databases and provide updates to clients on a regular basis- Present internally and externally on project portfolio- Identify potential risks to projects and implement processes and tactics to proactively mitigate

- 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 forward momentum in solution solving and implementation- Effectively communicate status updates on efforts to Executives in weekly status meetings- Collaborate with IT teams to implement solutions- Compose control plan and hand off to business units- Manage document creation, collaboration and organization in SharePoint

- 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 flows for internal team task management for development asks

- 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 objectives and scorecards for team to make sure we stayed on track.- Provide enhancement opportunities for Medallia to best fit our needs- Conduct UAT efforts for changes made to Medallia- Assist in building out topics for Text Analytics- Enhance Medallia NPS Survey forms to track all additional coaching efforts identified from feedback- Updated customer facing survey to obtain more transnational feedback to utilize to drive out actionable items to improve customer experience

Bachelor'S Degree, Fine And Studio Arts

Associate Of Arts - Aa, Painting