Reporting to the Senior Director, Clinical Data Management, I presently lead the development, training and implementation of the eCOA strategy within clinical development at Moderna across all development phases. Working to develop cross functional processes, industry best practices and drive organizational learning to ensure consistent adoption of eclinical technology with a focus on cost and operational efficiency, quality, data integrity, and user (site/patient) experience, and drive standardization and process improvement.

Serve as the Takeda subject matter expert on eCOA development, operations, and technical support. Created a Takeda eCOA management process including a new SOP, broadened RACI chart, and company-wide training materials. Build internal knowledge of strategic eCOA vendors, their organizations and capabilities to anticipate opportunities and risks. Implement effective governance of eCOA vendors and build strong relationships to maximize performance and deliver value. Facilitate efficient and collaborative resolution of escalations and conflicts with eCOA vendors. Deliver technical support for system setup and User Acceptance Testing, working with eCOA service providers to address service issues, and drive standardization and process improvement. Responsible for contributing to strategic provider relationships, assessing performance of the service providers and exploring new technologies and service providers. Serve as the lead both internally within R&D and externally across functions and service providers to study specific eCOA technology deployment and management strategies. Act as the R&D organization eCOA/ePRO expert and project manager for study deployment projects.

Serve as the Shire subject matter expert on eCOA development, operations, and technical support. Build internal knowledge of strategic eCOA vendors, their organizations and capabilities to anticipate opportunities and risks. Implement effective governance of eCOA vendors and build strong relationships to maximize performance and deliver value. Facilitate efficient and collaborative resolution of escalations and conflicts with eCOA vendors within GCDO. Deliver technical support for system setup and User Acceptance Testing, working with eCOA service providers to address service issues, and drive standardization and process improvement. Responsible for contributing to strategic provider relationships, assessing performance of the service providers and exploring new technologies and service providers. Serve as the lead both internally within GCDO and externally across functions and service providers to study specific eCOA technology deployment and management strategies. Act as the GCDO organization eCOA/ePRO expert and project manager for study deployment projects.

Lead cross-functional project teams to develop and deliver products to help clinical research industry companies obtain high quality data. Oversee contract execution and fulfill out-of-scope requests for multi-million dollar clinical trials. Develop and present product and study-workflow trainings to thousands of doctors and site coordinators. Drive project timelines to produce industry-leading electronic clinical outcome assessment (eCOA) software.

Provide excellent client services resulting in high levels of satisfaction ratings. Manage software development lifecycle from requirements gathering to testing and production releases. Diligent adherence to complex, internal deliverables ensuring product quality and timely delivery.

Assumed the roles and responsibilities of a Project Manager, including leading kick-off meetings with sponsors, authoring client-facing documentation, and managing study development, monitoring, and close out. Recorded and tracked key project metrics for clinical trials worth nearly $15 million in total revenue. Interviewed, trained, and mentored new and existing Project Coordinators (PCs). Identified process efficiencies and organized new training opportunities for on-boarding of newly hired PCs. Reported on key eCOA data monitoring and tracking metrics for client review through the heavy use of Oracle and Salesforce.

Collaborate with cross-functional project teams including working with the Project Manager, Software Engineer, Database Engineer, and Archive team to develop and deliver PHT products to help clinical research industry companies obtain high quality data. Managed inventory for PHT’s most aggressive and complex clinical trials as well as oversaw the deployment, maintenance, and return of over 10,000 devices to more than 45 countries globally. Wrote concise training manual synthesizing complex sponsor protocols, requirements, and specification documents for use in clinical trials. Report on key electronic Patient Reported Outcome (ePRO) data monitoring and tracking metrics for both internal and client review through the heavy use of Oracle and Salesforce. Record and track key project metrics for clinical trials worth nearly $15 million in total revenue.

Review and code legal invoices at Alan Gray, Inc. for adherence to clients’ guidelines. Analyze insurance company, defense firm and plaintiff firm files for financial exposure and other relevant data. Conduct research and author reports summarizing findings of the audits. Complete legal research on factual issues as instructed by the Vice President.

Reviewed settlement package documents from asbestos litigation cases to identify relevant data in preparation for upcoming depositions. Extracted information about each claimant’s asbestos exposure to determine insurance liability.

Served as project team leader with direct oversight of approximately 20 contract attorneys. Disseminated information to attorneys about review; trained attorneys on use of electronic review platform; conducted QC review of work; drafted daily status reports to Project Manager and handled human resources concerns. Conducted first level review and privilege log creation for civil litigation matters regarding breach of contract and intellectual property rights.

Represented immigrant clients in a range of legal proceedings including asylum, adjustment of status, and lost wages actions under a student practice order. Conducted interviews with clients, drafted documents, and performed legal research and writing. Successfully litigated a witholding of removal case.

Provided support for a small legislative team and assisted chief legal counsel in research and analysis of legislative initiatives. Staffed formal Senate sessions and prepared all documentation provided to the Senator for those sessions. Compiled and organized information on bills coming to the Senate or being heard by her committees.

Completed legal research, drafted legal and press-related documents, and analyzed case strategy for solicitors in the Human Rights department of a London-based law firm. Compiled research for potential and on-going cases. Participated in client conferences and legal team planning sessions. Observed trials and hearings.

Assisted trial team in prosecution of defendants accused of genocide, war crimes and crimes against humanity. Performed legal research, completed witness summaries, and wrote position papers on recently decided judgments that helped shape trial team strategy.

Recruited and motivated corporations and community organizations to participate in, and raise pledges for, the 2007 Walk for Hunger. Helped to build a 40,000 person walk which raised more than $3 million dollars to support emergency hunger-relief programs in Massachusetts.

Managed and organized large document production for antitrust cases to be tried in federal court. Reviewed, analyzed, and summarized documents for production as well as legal analysis. Prepared witness files for depositions and discovery purposes. Performed legal research using WestLaw. Administered document management software.

Coordinated closely with national Kerry campaign officials to build crowd events to inspire the candidate, energize the campaign field organization, and draw the attention of the press corps to the candidate’s campaign message. Designed and built events of up to 11,000 people for the presidential campaign in the state of Wisconsin.