Morrisville, North Carolina, United States
Nick is a Principal Clinical Data Scientist at Syneos Health. He has previously held the positions of Principal Clinical Data Manager, Senior Lead Clinical Data Manager, Clinical Data Manager II, Clinical Data Manager I, Clinical Data Associate III, Clinical Data Associate II and Clinical Data Associate I at PPD. Nick holds a M.S. in Clinical Research from Campbell University and a B.S. in Biological Sciences from North Carolina State University. Specialties Nick has experience in the therapeutic areas of Circulatory (Acute Coronary Syndrome, Critical limb ischemia, Acute Decompensated Heart Failure); Hepatic (Primary Sclerosing Cholangitis, NASH, Liver Fibrosis); Infections/Parasitic Diseases (Skin and Skin Structure Infections); Oncology (Relapsed Multiple Myeloma, Melanoma) and Ophthalmology (Neovascular Age-Related Macular Degeneration).
Acquire, process, clean, integrate and store data. Use programming tools to test, load, and pre-process standard and non-standard data. Ensure data validity through conformance checks and reconciling clinical study data from various sources. Identify and communicate data issues to drive resolution. Build Predictive models and machine learning algorithms. Provides data science technical support and expertise across the Biometrics function and other departments as needed. Apply data science techniques, such as R, Python, statistical modeling, and artificial intelligence. Works to ensure that outputs meet quality standards and project requirements. Present information using data visualization techniques. Provide subject matter expertise on process improvements and data conformance solutions. Collaborate with data engineering and clinical product development teams. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. Proposes and leads the development of process improvements, programming tools and automation for standardization and efficiency, and the development of new concepts, technologies and products to meet emerging customer needs. Analyzes information and develops innovative solutions to programming and data analysis challenges across the department. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
Tracks Data Management timelines for assigned projects and ensures that all applicable Data Management team members are aware and on target for deliverables. Authors the Data Management Plan (DMP), outlining all data management responsibilities. Authors the Data Transfer Agreement (DTA) with third party external data vendors. Oversees UAT of clinical data systems (EDC, eCOA, IWRS) to be implemented on a project. Conducts project-specific training throughout the course of the project, as needed. Attends and presents at client bid defense meetings. Attends and presents at project meetings as required. Oversees the completion of a comprehensive data review of clinical data. Ensures medical coding is performed in a timely manner. Ensures DM documentation is audit-ready and filed appropriately at all times. Coordinates all activities in preparation for database lock, including Data Review Meeting. Produces status or progress reports, listings, and other output as required during the course of the project. Monitors budget and scope of work for contracted DM services throughout the duration of the project, identifying out of scope or budget activities/collaborating with the project manager when out of scope documentation and costs are needed. Manages complex project programs with multiple studies within a client portfolio. Participates in Synteract and Data Management initiatives (e.g. process development/improvement, technology vendor selections, etc.). Develops tools to improve job function (e.g. Lead DM checklist, helpful training for Clinical Data Managers, etc.). Serves as a subject matter expert (SME) for a Data Management process or technology.
Acts as a Lead Data Manager for multiple, high volume and extremely complex studies within a development program. Responsible for functional, administrative and financial oversight of assigned projects. Provides support, oversight and coaching to the DM team to ensure that all tasks are completed accurately, on time and within budget to meet or exceed client expectations. Acts as primary liaison for project team and client. May develop and implement study specific training for DM project staff and performs independent reviews of DM deliverables following CDM guidelines. Monitors, evaluates and proposes mitigation strategies surrounding risk to deliverables and finances. Participates in business development activities by assisting with bid preparation and representing data management at bid defense meetings, where required. Additionally, promotes repeat business by developing relationships with new and existing clients. Responsible for administrative oversight and may provide financial oversight of designated projects. Performs project forecasting of hours and identification of resource requirements and manages project budgets including identification of out of scope work and participate in the Contract Modification process. Participates in the development and implementation of processes, procedures and training for the data management function as directed. Mentors junior level staff and peers on all associated tasks within a study or program. Independently leads and delegates tasks to ensure timely completion of project activities to project timelines, quality and budget
DM lead for internal/client team meetings and communication. Provides Metric reports for internal/external project teams. Provides staffing projections for DM activities for studies. Implements process or system improvements for global implementation. Ownership for project deliverables within Data Management scope of services. Discusses roadblocks with PM & principal for completing study objectives in a timely manner. Reviews project budgets and staffing projections for data operation activities. Provides training of other DM staff on project specific processes. Creates Data Review Plan for studies and develops standards for the Department. Creates listings using ad hoc query tools. Oversees the issuing of queries and review query responses with the highest level of quality based upon the Data Review Plan. Drafts the CRF design, edit check specification and DM listings. Facilitates clinical team review of system (eCRFs, Edit Checks, and Data Review Plan, etc.). Documents comments from internal and sponsors for discussion and approval. Ensures all non-DM activities related to database development are completed in a timely manner. Ensures all database modifications are communicated with team and implemented effectively. Oversees the entry of data in the Development or Quality Control systems used for validation. Assists with the validation of CRF system (CRF content & edit checks), Reports using EDC Reporting and/or J-Review, and associated change control. Provides feedback to other project team members and managers to improve the deliverables.
Acts as the lead data manager for one or more projects and may also provide support to another lead data manager on one or more projects. Independently and efficiently oversees and/or performs, with quality, all data management cleaning activities in accordance with the Data Validation Manual (DVM) and/or client documentation within an assigned study. Mentors junior level staff on all associated tasks within a study. Liaise with the sponsor and other functional groups as required and communicates with management regarding all data management activities within studies. Designates tasks appropriately within the team ensuring all work conducted is completed to the acceptable quality in accordance with global Standard Operating Procedure (SOPs) and the DVM. Represents Clinical Data Management at internal and external meetings and presentations including business development activities. Responsible for administrative oversight and may provide financial oversight of designated projects. Leads multiple, high volume/highly complex studies.
Acts as a Lead Clinical Data Manager for one or more projects and provide support to other Lead Clinical Data Managers for one or more projects. Liaisons with clients and colleagues in other functional groups as required. Fulfills all data management cleaning activities in accordance with the Data Validation Manual (DVM) and/or client documentation. Designates tasks appropriately within the team ensuring all work conducted is completed to the acceptable quality in accordance with global Standard Operating Procedure (SOPs) and the DVM. Represents Clinical Data Management at internal and external meetings and presentations.
Performed all aspects of the data cleaning process with minimal supervision and in accordance with GCPs and SOPs/WPDs. Key responsibilities were data list reviews, reconciliation of Serious Adverse Events and third party vendor data. Supported the Lead Data Manager by performing activities such as CRF design, database design and Data Validation Manual creation. Performed initial review of data discrepancies and database updates.
Marketed negative pressure wound therapy equipment to various physicians. Performed multiple training sessions to physicians, nurses, etc. Key responsibilities were marketing, training, and various tasks around the office such as logging referrals into the computer system.