Leading Data Management activities, at a program level, for all aspects of clinical trial data management from study start up through database lock and study close.

Led Data Management activities for a portfolio of studies including timeline, budget, quality management, client relationship and the facilitation of their projects within the data management team. • Responsible for Biometrics deliverables of multiple ongoing projects.• Lead all Data Management activities from contract award through database closeout and delivery of final datasets. • Manage global teams in execution of study-critical tasks such as eCRF design and database implementation, external data integration and reconciliation, ongoing manual data review, Medical and Safety review, and development and programming of statistical datasets.• Primary point of contact for all external vendors and clients.• Development, management, and reporting of DM timelines and budgets, providing cost analysis and risk assessments to support Contracts and Project Management teams.

Senior Lead Clinical Data Manager for contract research organization, providing full data management services for research trials across multiple therapeutic areas.• Responsible for management of clinical trial data for multiple projects• Accountable for implementation, maintenance and close-out of clinical databases• Lead development of essential study documentation, including eCRF specifications and completion guidelines, edit check specifications, and data management plans• Lead data cleaning, SAE reconciliation, external data reconciliation, and database freeze and lock activities

Lead Clinical Data Manager for contract research organization providing full data management services for research trials across multiple therapeutic areas.• Responsible for successfully providing data management deliverables that met internal and external client needs.• Led all data science activities for multiple concurrent clinical trials.• Served as the primary contact for internal and external team members regarding data management activities.• Authored documents such as interim lock plans, database closure plans, and database unlocking plans.• Tracked milestones, tasks, and overall budget for assigned projects.• Participated in sponsor and/or third-party audits.• Developed forecasts of units, hours, and resourcing for data management tasks.• Developed plans and oversaw timelines for activities between last patient visit and database lock.• Contributed to bid and proposal development and participated in bid defense meetings.

Lead Clinical Data Manager for contract research organization providing full management services for oncology research trials.• Led cross functional Data Science teams (Statisticians, Programmers, Data Manager) to plan for and deliver all data deliverables. This includes creating and managing all timelines and project plans.• Led Data Science activities for 4-6 concurrent clinical trials. This includes but is not limited to:o CRF designo Database design and testingo Report specifications and testingo Data Management Plan developmento Development of data quality checkso Management of data sources from outside vendorso Delivery of a locked database.o Management of all mid-study changes to the database• Represented Sarah Cannon Development Innovations Data Science externally in Business Development activities.• Participated in the training and mentoring of junior staff including Clinical Data Analysts.• Key liaison with client to ensure the highest possible customer service in order to win repeat business.• Enforced data standards with project team, physicians and clients.• Identified data science scope changes and provides cost analysis to the project manager for these scope changes.• Directed activities of Clinical Data Analysts.• Accountable for compliance to all SOPs and regulatory requirements.• Accountable for ensuring all required documentation is created and filed in the Trial Master File.

Project manager and study lead for contract research organization providing clinical laboratory services.• Key contact for clients; liaison between Clients, CRO, and Covance.• Managed internal Covance study team to provide reliable study service to the client.• Provided project management oversight; focusing on key client deliverables through budget, risk, and milestone management. • Facilitated communications between Client and extended Covance study team.• Performed contract reviews to ensure quality implementation of client specifics and requirements. • Managed a portfolio of global and local studies with varying complexity. • Ensured that all customer expectations are documented and acted upon in compliance with regulatory requirements.• Responsible for the implementation, monitoring and reporting of study performance metrics.

Marketing and product development for educational technology firm.• Provided marketing copy for all catalog titles, digital and print.• Provided support for inside sales team and product promotion to varied customer base, both professional and academic.• Product development, including editorial support and quality control.• Management of market research initiatives and end-user data, including asset ownership of research databases warehousing customer feedback and testimonial materials.• Project Manager for several database development initiatives with annual company investment exceeding $100,000. In charge of all phases of development including contracting, budgeting, execution, implementation, and rollout.• Development of product messaging conventions and internal tools for the collection, management, and application of promotional product metadata.• Lead coordinator for authors, contributors, and internal stakeholders in the development of product-specific marketing initiatives for dissemination to both proprietary and third-party distribution outlets, including retailers Amazon.com, Barnes and Noble, and Chegg.• Project management for title development in more than a dozen genres and disciplines, leading product messaging services for a wide variety of content and production formats.• Coordination of content delivery across diverse platforms; with specific expertise in digital product development and concomitant promotional strategies.

Project management and maintenance of international research studies.• Successfully managed more than twenty clinical trials from startup through maintenance to database lock, with active amendments, for more than a dozen sponsors across all four clinical trial phases.• Study management experience in a variety of therapeutic areas, including oncology, cardiology, endocrinology, nephrology, and neurology.• Experience in trial management systems including CTMS, EDC, and IVRS.• Provide support for business development and proposal preparation, with specific experience in preparation for bid defenses.• Developed written reports for distribution to medical professionals and study sponsors.• Designed and produce marketing and patient recruitment materials.• Provided support for contract development, project timeline maintenance, site selection, and patient recruitment/retention.• Developed study documentation, including trial newsletters, study contracts, feasibility assessments, confidentiality agreements, FDA audit findings, and institutional review board submissions.• Managed routine departmental support functions including shipping, archiving, filing, faxing, meeting organization, and meeting documentation.• Managed and maintained departmental databases utilizing both internal proprietary systems and common-use applications such as Oracle systems and Microsoft Access.• Coordinated communication between study sponsors, project vendors, health services professionals, and trial managers.

Data management for clinical research on a multi-departmental basis. • Headed team-oriented data processing programs providing high quality data entry services as well as streamlining filing systems dedicated to the organization of critical research sourced from multiple clinical studies.• Provided interdepartmental support for communication and project maintenance, allowing for efficient processing of information across multiple clinical research disciplines.• Served as liaison between up-stream and down-stream data collection processes, allowing for high quality information acquisition and organization, providing a foundation for the interpretation and application of clinical data.