New York City Metropolitan Area
With over 10 years of clinical research experience in various therapeutic areas, I am a Senior Manager of US Field Medical Excellence Operations at Takeda, a global biopharmaceutical company. In this role, I lead and support high-impact, high-priority projects and initiatives that advance the operational efficiency of the US Field Medical department. I have a Master of Public Health degree in Global Health Program Design, Monitoring and Evaluation, and an Advanced Graduate Certificate in Public Health, which enable me to apply a public health perspective and a data-driven approach to my work. I am passionate about health system strengthening, equitable access to medicines, and clinical trial diversity, and I seek to contribute to these goals through my skills in project/program management, strategy and operations, change management, data analysis, and process improvement. I am looking for opportunities where I can leverage my clinical research and public health background, and collaborate with diverse and dynamic teams to deliver value and impact.
• Provides project/program management to ensure internal, cross-functional, cross-divisional project plans are in place for GDO- related initiatives • Work directly with the GDO Functional Heads, and key stakeholders outside departments to support the strategic direction of GDO by leading high-impact, high-priority projects and overseeing department-wide initiatives. • Support the creation and management of GDO’s communications strategy • Supporting and leading key initiatives that have cross-functional impact and that are critical to GDO’s business objectives and/or Takeda’s global business objectives. • Support transformational project/initiatives and change management activities to advance GDO’s mission to achieve predictable delivery • Support the development and execution of a fit-for-purpose communication strategy pertaining to cross-functional initiatives. • Support the execution of opportunities for the enhancements of core capabilities within GDO functions and efficiencies, including process improvement. • Utilize project and program management expertise to drive project teams to achieve clarity on issues and focus on effective contingencies; interface with management and influence decision-making, monitor progress, gaps, risk management to ensure progress and business continuity • Support cross-functional and R&D projects focused on operational excellence, including representing GDO on cross-functional teams. • Support identification of project and resource priorities that align with global business objectives. Work closely with stakeholders to balance operational execution with GDO strategy. • Support activities related to GDO leadership team meetings and workshops (development of agenda, coordination of logistics, facilitation of discussions etc.) • Support activities related to GDO Onboarding and engagement (GDO Playbook, SharePoint, Office Hours etc.) • Develop and implement tools and templates to enable consistency and transparency across GDO projects
• Contributes and coordinates budget and operations board reviews and approvals of all trial budgets and operational execution. • Coordinates and facilitates portfolio reviews, highlight key trends across disease areas, support mitigation strategies of portfolio related key issues and risks. • Support GMA/OMA KPI and metrics collation and coordinating activities with respective stakeholders, including but not limited to budget and operations alignment board reviews, portfolio reviews, etc. • Coordinate agenda creation, meeting coordination, minutes management and metric compilation for departmental meetings and activities, such as, but not limited to, budget and operations alignment board meeting, portfolio review meeting, forums, etc. • Support and develop platforms, such as SharePoint, that enable automation and workflows, centralization of organizational knowledge, sharing of best practices, and business adoption of ideas and information. • Support creation, shaping and managing the internal/external messaging and communication strategy impact Clinical Operations, ensuring alignment with Clinical Operations objectives and priorities. • Support and facilitate resource deployment and reallocation across areas, including tracking and reporting. • Participate in assigned cross-functional/divisional operational work streams and initiatives, including but not limited to Governance and Compliance, Real World Evidence, Research Collaborations, etc. • For assigned area of responsibility, assist Head Strategy and Operations in building Clinical Operations function budget and manage budget targets, including HQ travel budget, Service Level Agreements, and providing expertise and guidance to Global Group Heads and (associate) Global Trial Directors on trial budget and resource allocation. • Support respective GMA, OMA teams and line functions in the development of Working Practices and or Guidelines required for GMA/OMA, when applicable.
Global Medical Affairs, Oncology
• Accountable for supporting the Global Medical Affairs (GMA) ClinOps Director of Excellence and Innovation and Head of Strategy and Operations to drive operational excellence across the Global Medical Affairs (GMA) portfolio. • Implement process efficiencies and best practices for the management and oversight of various GMA Clinical Operational activities under Novartis SOPs. • Participation in cross-divisional/functional work streams/initiatives, logistical activities for the GMA Protocol Review Committee (PRC) Office and agenda/minute coordination for multiple ClinOps departmental meetings.
• Organizes and delivers analyzable reports and metrics to the clinical study lead. • Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings. • Collates data for assessments such as feasibility and site selection and reviews site usability database. • Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures. • Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders. • Collates materials for training and investigator meetings. • Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan. • Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings. • Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance. • Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form). • Manages and maintains team SharePoint and/or shared drive sites, as needed. • Communication with sites as directed and maintains site contact information. • Contributes to line listings review for Blind Data Review Meeting (BDRM). • May manage or contribute to oversight of Third Party Vendors (TPV). • Tracks and monitors close out activities – study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits. • Participates in Standard Operating Procedures (SOPs) revisions or departmental
• Focus on global project and program level responsibilities that may vary based upon study type and outsourcing status. • Manages the execution and setup of Data Monitoring Committee’s, Independent Review Committee, adjudication process and vendor set-up. • Responsible for Investigator Meeting planning and execution. • Collaborates with the Protocol Manager to ensure complete review of protocol level listings as outlined in the data review plan. • Manages the global setup of study level non-clinical supplies. • Manage inspection activities (requests for documentation, coordination of information to/from BMS site, monitors). • Provide support across Investigator Sponsored Research, Health Economic Research Outcomes and Registrational projects/studies. • Co-lead weekly calls with AMI meeting planner (GBT and Inception for virtual IMs). • First point of contact for budget planning, requesting work order. • Completion of Investigator Meeting proposal form and obtain appropriate signatures. • Manage DMC Charter with MM/GBS/DMC/CDMG from draft-final publish and obtain DMC Charter Approval Form. • Ensure status for overall study and enrollment are up to date • Update needed M&D tabs/integrated checklist - when appropriate. • Enable study and configure study-level settings in My Trials, including Subject Visit Schedule. • Manage setup of online order form for sites to submit global Internal Requests, allowing site requests for global supplies. • Respond to Quality Review findings for study level documents. • Complete quality review assessment to confirm no open study quality issues. • Request Archive for Study Binder once Site and Country Binders. • Development and implementation of work instructions, procedural guides and maintenance trackers to ensure audit-readiness and the delivery of high-quality clinical trial support in accordance with BMS policies. • Tier Escalation and Communication Initiative – Investigator Sponsored Research department
(On Assignment at Sanofi) Ensure the delivery of high quality clinical trial support in a timely fashion in accordance with Sanofi policies & procedures. Updating databases(contact information), CTMS system and familiar with collecting regulatory documents and maintaining the trial master files, TMF and eTMF. Point of contact for incoming site communications. Follow up with sites to ensure reception of pre-study package and collect IRB meeting date. Collect and coordinate completion of study documents, lab specimen labels and other requirements. Track IRB approvals and all documentation required for site start-up. Order CRFs for office and sites' specific, or follow up on site's training for use of electronic CRFs and central lab supplies, and other study supplies. Verify with sites to ensure all materials were received and that the site is ready for the initiation visit. Preparation and review of presentations to be used for the initiation visit. Prepare scientific study tools (study coordinator handbooks, visit schedulers, dose calculator, etc) upon needs. Run enrollment reports, track CRFs books and re-order if necessary and proactively monitor enrollment and address drug supply issues. Track status of study document and ensure that site communications are sent and received by Records Management, in coordination with study file management team as appropriate. Support site audits, file management, and interact with sites, clinical team, CRAs and other study team personnel to resolve issues with study documents including missing documents, incomplete documents, misfiled documents. Communicate site close-out dates and reconcile payments schedule, ensure accuracy and completeness. Ensure electronic study management tool reflects when site is closed including completed patients, event dates. Reconcile and ensure all final study documents are correctly filed in electronic repository. Request Grant payments and track and reconcile payments.