Global Clinical Project Leader

• Mar 2022 - Oct 2023

Provide overarching management of clinical trial execution. Responsible for developing the tactical portion of the operational component of the clinical development plan; in consultation with key stakeholders, including high level resourcing (timelines, budget, and resources), development of clinical project standards, tools, metrics, and assessing the impact of any proposed changes to the program. Responsible for employing risk-based management strategies, implementing solutions, and providing… Show more Provide overarching management of clinical trial execution. Responsible for developing the tactical portion of the operational component of the clinical development plan; in consultation with key stakeholders, including high level resourcing (timelines, budget, and resources), development of clinical project standards, tools, metrics, and assessing the impact of any proposed changes to the program. Responsible for employing risk-based management strategies, implementing solutions, and providing accurate and timely information on the program and fostering continuous improvement in clinical development. Show less Provide overarching management of clinical trial execution. Responsible for developing the tactical portion of the operational component of the clinical development plan; in consultation with key stakeholders, including high level resourcing (timelines, budget, and resources), development of clinical project standards, tools, metrics, and assessing the impact of any proposed changes to the program. Responsible for employing risk-based management strategies, implementing solutions, and providing… Show more Provide overarching management of clinical trial execution. Responsible for developing the tactical portion of the operational component of the clinical development plan; in consultation with key stakeholders, including high level resourcing (timelines, budget, and resources), development of clinical project standards, tools, metrics, and assessing the impact of any proposed changes to the program. Responsible for employing risk-based management strategies, implementing solutions, and providing accurate and timely information on the program and fostering continuous improvement in clinical development. Show less

Senior Manager, Clinical Operations

• Oct 2020 - Mar 2022

Responsible for the overall oversight and operational activities of clinical studies (Phases I-IV), including the design, planning and coordination; maintenance of the study-level reporting systems; and the execution, tracking and creation of progress reports on the clinical trials, ensuring that the general performance and all operational aspects of the clinical studies are proceeding in accordance with the Clinical Development Plan. Independently organizes and manages multiple activities… Show more Responsible for the overall oversight and operational activities of clinical studies (Phases I-IV), including the design, planning and coordination; maintenance of the study-level reporting systems; and the execution, tracking and creation of progress reports on the clinical trials, ensuring that the general performance and all operational aspects of the clinical studies are proceeding in accordance with the Clinical Development Plan. Independently organizes and manages multiple activities while simulatneously ensuring clinical study timeline milestones are met and studies are completed in accordance with the protocol and ICH/GCP requirements. Establishes collaborative working relationships with internal members of the Clinical Development group, as well as with members of the Service Providers (SPs), consultants, contractors and colleagues from other functions. Review protocol and case report forms (CRFs), applicable SOPs, team communications, computer software/IT training, the importance of pharmacovigilance and adverse event reporting so that all team members are not only informed, but also aligned. Manages budgetary spend of the clinical trial study and negotiates clinical trial agreements and budgets, managing vendor site payments with relevant project team and Legal team members. Responsible for site identification and qualification, as well as site start-up, initiation and conduct of the study, guaranteeing timely recruitment of trial participants. Monitors trial progress, ensuring compliance with and adherence to the project plan, while identifying, assessing and resolving any problems. Ensures efficient and effective data collection and documentation, management and analysis upon study completion, followed by final data reporting. Show less Responsible for the overall oversight and operational activities of clinical studies (Phases I-IV), including the design, planning and coordination; maintenance of the study-level reporting systems; and the execution, tracking and creation of progress reports on the clinical trials, ensuring that the general performance and all operational aspects of the clinical studies are proceeding in accordance with the Clinical Development Plan. Independently organizes and manages multiple activities… Show more Responsible for the overall oversight and operational activities of clinical studies (Phases I-IV), including the design, planning and coordination; maintenance of the study-level reporting systems; and the execution, tracking and creation of progress reports on the clinical trials, ensuring that the general performance and all operational aspects of the clinical studies are proceeding in accordance with the Clinical Development Plan. Independently organizes and manages multiple activities while simulatneously ensuring clinical study timeline milestones are met and studies are completed in accordance with the protocol and ICH/GCP requirements. Establishes collaborative working relationships with internal members of the Clinical Development group, as well as with members of the Service Providers (SPs), consultants, contractors and colleagues from other functions. Review protocol and case report forms (CRFs), applicable SOPs, team communications, computer software/IT training, the importance of pharmacovigilance and adverse event reporting so that all team members are not only informed, but also aligned. Manages budgetary spend of the clinical trial study and negotiates clinical trial agreements and budgets, managing vendor site payments with relevant project team and Legal team members. Responsible for site identification and qualification, as well as site start-up, initiation and conduct of the study, guaranteeing timely recruitment of trial participants. Monitors trial progress, ensuring compliance with and adherence to the project plan, while identifying, assessing and resolving any problems. Ensures efficient and effective data collection and documentation, management and analysis upon study completion, followed by final data reporting. Show less

Senior Clinical Project Manager, Investigator Sponsored Trials

• Mar 2018 - Sep 2020

responsible for the planning, implementation, execution, oversight and management of Investigator Sponsored Trials (ISTs) per the IST SOP(s). Manages clinical outsourcing to vendors as needed. May author, review and approve various study related documents and plans. Identifies issues, interprets data, and suggests and implements solutions and mitigation as required. Responsible for the budgetary and enrollment forecasting and tracking of each assigned IST, and develops and oversees study… Show more responsible for the planning, implementation, execution, oversight and management of Investigator Sponsored Trials (ISTs) per the IST SOP(s). Manages clinical outsourcing to vendors as needed. May author, review and approve various study related documents and plans. Identifies issues, interprets data, and suggests and implements solutions and mitigation as required. Responsible for the budgetary and enrollment forecasting and tracking of each assigned IST, and develops and oversees study timelines.

Clinical Project Manager, Investigator Sponsored Trials

• Dec 2017 - Mar 2018

• Represents and leads the study team to develop, execute and manage global ISTs in accordance with Karyopharm IST goals, strategy, business plans and SOPs, in compliance Good Clinical Practices (GCP) and ICH Guidelines • Assists with the planning and execution of applicable sponsor-investigator’s meetings, joint steering committee meetings, etc. • Maintains accurate metrics for assigned ISTs • Ensures the delivery of clinical trial supplies (drug supply, lab kits) in collaboration… Show more • Represents and leads the study team to develop, execute and manage global ISTs in accordance with Karyopharm IST goals, strategy, business plans and SOPs, in compliance Good Clinical Practices (GCP) and ICH Guidelines • Assists with the planning and execution of applicable sponsor-investigator’s meetings, joint steering committee meetings, etc. • Maintains accurate metrics for assigned ISTs • Ensures the delivery of clinical trial supplies (drug supply, lab kits) in collaboration with the clinical supply team • Manages escalation of study related issues and communicates as appropriate with management and other R&D functions • Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight • Manages clinical vendor activities to ensure quality and alignment with Karyopharm and regulatory requirements • Monitors progress of ISTs and produces regular and ad hoc reports, slides, and presentations • Reviews, approves, tracks and ensures compliance with contractual reporting requirements across all ISTs • Provides IST reference material for responses during regulatory inspections and NDA submission(s) • Continually collaborates with cross functional teams on audit readiness plans • Reviews and monitors compliance with trial budgets and contracts with Sponsors, Institutions, vendors, and investigative sites, as applicable • Evaluates site and study performance metrics against agreed upon budget, deliverables and timelines • Works with the IST Associate Director and Regulatory/PVG department to maintain an accurate summary of IST safety information (i.e. DSUR and IB updates) • Oversees and monitors the management of clinical studies ensuring they are conducted in accordance with the approved study plans/contracts/protocols through regular investigator site /clinical vendor contact • Reviews and ensures accuracy and necessary follow-through regarding correspondence and reports relating to the safety and regulatory IST updates

Senior Manager, Site Management

• Nov 2016 - Nov 2017

• Successfully manages Site Management operations and department activities • Supervises, mentors and trains all SM staff including site managers, clinical research associates, project coordinators and systems administrators • Accountable for the performance of SM staff both individually and as a group • Ensures SM compliance with SOPs and performance in meeting relevant study milestones and timelines • Directs execution of site initiation and start-up, site monitoring, site… Show more • Successfully manages Site Management operations and department activities • Supervises, mentors and trains all SM staff including site managers, clinical research associates, project coordinators and systems administrators • Accountable for the performance of SM staff both individually and as a group • Ensures SM compliance with SOPs and performance in meeting relevant study milestones and timelines • Directs execution of site initiation and start-up, site monitoring, site management and site/study close-out according to GCP internal SPOs and polices, and within required timelines • Assists in the development of vendor budgets and scopes of work • Oversees the development of site level recruitment strategy and contingency plans • Develops key metrics to monitor site performance, site management/monitoring vendor and individual study activity • Manages and oversees the site/investigator selection and feasibility processes • Develops and monitors performance metrics of site management/monitoring vendors • Develops and monitors site quality and performance metrics • Develops and maintains professional relationships with site management vendors and provides oversight Show less • Successfully manages Site Management operations and department activities • Supervises, mentors and trains all SM staff including site managers, clinical research associates, project coordinators and systems administrators • Accountable for the performance of SM staff both individually and as a group • Ensures SM compliance with SOPs and performance in meeting relevant study milestones and timelines • Directs execution of site initiation and start-up, site monitoring, site… Show more • Successfully manages Site Management operations and department activities • Supervises, mentors and trains all SM staff including site managers, clinical research associates, project coordinators and systems administrators • Accountable for the performance of SM staff both individually and as a group • Ensures SM compliance with SOPs and performance in meeting relevant study milestones and timelines • Directs execution of site initiation and start-up, site monitoring, site management and site/study close-out according to GCP internal SPOs and polices, and within required timelines • Assists in the development of vendor budgets and scopes of work • Oversees the development of site level recruitment strategy and contingency plans • Develops key metrics to monitor site performance, site management/monitoring vendor and individual study activity • Manages and oversees the site/investigator selection and feasibility processes • Develops and monitors performance metrics of site management/monitoring vendors • Develops and monitors site quality and performance metrics • Develops and maintains professional relationships with site management vendors and provides oversight Show less

Lead Clinical Research Associate/Project Manager, Late Phase Oncology Program

• Dec 2015 - Sep 2016

• Led cross functional teams and was responsible for the oversight and management of study timelines as well as the financial and vendor management of a multi-national, Phase II ovarian cancer drug study for a “rescue mission” to get study back in successful position • Conducted monitoring/co-monitoring visits at investigative sites. • Verified and monitored adherence to the essential document collection process and operational plans. • Contributed to the clinical review of Case… Show more • Led cross functional teams and was responsible for the oversight and management of study timelines as well as the financial and vendor management of a multi-national, Phase II ovarian cancer drug study for a “rescue mission” to get study back in successful position • Conducted monitoring/co-monitoring visits at investigative sites. • Verified and monitored adherence to the essential document collection process and operational plans. • Contributed to the clinical review of Case Report Forms (electronic as applicable), data review plan, and other data management documents and corresponding completion guidelines. • Led/assisted in oversight of the identification and selection of investigator sites. • Assisted and/or participated in planning and conduct of study operational study meetings. • • Collaborated with the cross functional team on selection of and management of clinical vendors for quality of service. • Managed escalation of study related issues and communicated as appropriate with management and other operational team members. • Troubleshot, advised and followed trial progress with investigative site staff and clinical vendors. • Managed subject screening/enrollment, data collection and query resolution at investigative sites. • Prepared key reports and outputs for progress of trial and quality issues/concerns • Addressed study site issues/concerns with the investigator, determined root cause, and independently offered corrective and preventative actions, documenting follow-up activities and outcomes. • Prepared materials for and participated/led project team meetings. • Developed and prepared training for team members on project specific tasks as applicable. Show less • Led cross functional teams and was responsible for the oversight and management of study timelines as well as the financial and vendor management of a multi-national, Phase II ovarian cancer drug study for a “rescue mission” to get study back in successful position • Conducted monitoring/co-monitoring visits at investigative sites. • Verified and monitored adherence to the essential document collection process and operational plans. • Contributed to the clinical review of Case… Show more • Led cross functional teams and was responsible for the oversight and management of study timelines as well as the financial and vendor management of a multi-national, Phase II ovarian cancer drug study for a “rescue mission” to get study back in successful position • Conducted monitoring/co-monitoring visits at investigative sites. • Verified and monitored adherence to the essential document collection process and operational plans. • Contributed to the clinical review of Case Report Forms (electronic as applicable), data review plan, and other data management documents and corresponding completion guidelines. • Led/assisted in oversight of the identification and selection of investigator sites. • Assisted and/or participated in planning and conduct of study operational study meetings. • • Collaborated with the cross functional team on selection of and management of clinical vendors for quality of service. • Managed escalation of study related issues and communicated as appropriate with management and other operational team members. • Troubleshot, advised and followed trial progress with investigative site staff and clinical vendors. • Managed subject screening/enrollment, data collection and query resolution at investigative sites. • Prepared key reports and outputs for progress of trial and quality issues/concerns • Addressed study site issues/concerns with the investigator, determined root cause, and independently offered corrective and preventative actions, documenting follow-up activities and outcomes. • Prepared materials for and participated/led project team meetings. • Developed and prepared training for team members on project specific tasks as applicable. Show less

Senior CRA

• May 2012 - Oct 2015

• Acted in lead CRA role, responsible for the overall conduct and management of multiple clinical trials in various therapeutic areas. • Conducted all types of study monitoring visits, inclusive of remote monitoring activities, to ensure site compliance with data entry, query resolution and safety reporting timelines, as well as identifying site issues/trends for investigation • Participated in the development of study related documents, including protocol, Informed Consents, Case… Show more • Acted in lead CRA role, responsible for the overall conduct and management of multiple clinical trials in various therapeutic areas. • Conducted all types of study monitoring visits, inclusive of remote monitoring activities, to ensure site compliance with data entry, query resolution and safety reporting timelines, as well as identifying site issues/trends for investigation • Participated in the development of study related documents, including protocol, Informed Consents, Case Report Forms, source documents, training materials, regulatory binder elements, and other resource materials. • Actively involved in site contracting processes, inclusive of development of Confidentiality Agreements; development and negotiation of site budgets and Clinical Trial Site Agreement language • Participates and assists in the identification and evaluation of Investigators and sites. • Organized and prepared trial related material and presentations for Investigator/Coordinator meetings and trainings; • Provided continual training and support to Investigative sites on protocol and procedures. • Developed monitoring plan and manages Regional CRA study team(s), including Regional CRA selection and interview process, performance reviews, and adherence to monitoring plan. • Maintained an effectual relationship with Sponsors, Study sites, and Regional CRAs to assure accurate and timely completion of all contracted activities. • Worked closely with other departments to ensure the overall study timelines are met. • Reviewed and approved investigator site payments and conducted full reconciliation of study payments throughout study • Troubleshot inefficiencies and developed creative solutions for streamlining processes and work flows. • Provided ongoing site management support from study start-up through completion. • Mentored less experienced Clinical Research Associates and department staff. • Chaired committees aimed at identifying additional departmental goals and areas of growth

CRA II

• Jul 2011 - May 2012

• Acted in lead and co-lead CRA roles, responsible for the overall conduct and management of multiple clinical trials in various therapeutic areas. • Responsible for implementation and conduct of all stages of clinical studies including study planning, execution, monitoring and completion activities to include Device Post Approval and IDE studies • Independently performed all types of monitoring visits, including initiation, interim and close-out and helped resolve issues at Investigative… Show more • Acted in lead and co-lead CRA roles, responsible for the overall conduct and management of multiple clinical trials in various therapeutic areas. • Responsible for implementation and conduct of all stages of clinical studies including study planning, execution, monitoring and completion activities to include Device Post Approval and IDE studies • Independently performed all types of monitoring visits, including initiation, interim and close-out and helped resolve issues at Investigative sites with the support of other members of the Clinical Project Team. • Reviewed Confidentiality Agreements and negotiated site budgets and Clinical Trial Agreements. • Worked with lead CRA(s) and/or Sponsor in identifying and screening qualifications of appropriate investigative sites; maintained a site/investigator selection system/process. • Reviewed and approved Site Informed Consent Forms for submission to site IRBs. • Assisted with developing and maintaining databases for tracking of regulatory documents, work flow process and other essential trial related documents; worked closely with investigative sites during the Regulatory Document process from start-up through close-out phases. • Assisted with developing and managing regional monitoring teams, inclusive of monitor selection, oversight and regular performance evaluations

CRA I

• Apr 2009 - Jul 2011

• Responsible for coordinating and managing activities related to the conduct of all phases of clinical trials. • Independently performed all types of monitoring visits, including initiation, interim and close-out and helped resolve issues at Investigative sites with the support of other members of the Clinical Project Team. • Investigator Initiated studies, NIH studies, and Phase II-III Pharmaceutical studies. • Assisted with the design and review study agreements, Informed Consent… Show more • Responsible for coordinating and managing activities related to the conduct of all phases of clinical trials. • Independently performed all types of monitoring visits, including initiation, interim and close-out and helped resolve issues at Investigative sites with the support of other members of the Clinical Project Team. • Investigator Initiated studies, NIH studies, and Phase II-III Pharmaceutical studies. • Assisted with the design and review study agreements, Informed Consent Forms and other study specific forms and templates. • Prepared and conducted team meetings and study trainings • Prepared weekly study progress reports for entire study teams, including, but not limited to, site contract negotiations status, site start-up status, overall enrollment, site payments and monitoring activities • Provided centralized site support and coordination to assure timely completion of all contracted activities. • Reviewed electronic case report forms for completeness, clarity, and conformity to available source documents • Updated and revised in-house department standard operating procedures and guidelines to reflect current regulations.

Senior Site Management Coordinator

• Mar 2008 - Mar 2009

• Assisted in the creation of departmental standard operational procedures and guidelines. • Participated in the conduct of clinical studies at all phases, including study start-up, execution, monitoring and close-out activities. • Assisted in identifying and screening appropriate investigative sites and helped facilitate the site/investigator selection system/process. • Instrumental in the development and review of site budgets, Informed Consent Forms, study specific regulatory… Show more • Assisted in the creation of departmental standard operational procedures and guidelines. • Participated in the conduct of clinical studies at all phases, including study start-up, execution, monitoring and close-out activities. • Assisted in identifying and screening appropriate investigative sites and helped facilitate the site/investigator selection system/process. • Instrumental in the development and review of site budgets, Informed Consent Forms, study specific regulatory and training documentation, monitoring reports and other study documents and templates. • Worked closely with investigational sites during the regulatory process from start-up through close-out phases. • Developed and maintained databases for tracking of regulatory documents, submissions, budgets and contracts, and device/drug accountability and other essential trial related items. • Organized and prepared trial related materials for Investigator and/or Coordinator meetings. • Assisted in the training of investigational sites on protocol and procedures. • Observed and participated in all types of study monitoring visits from qualification to closeout visits. • Assisted in management of regional study monitoring teams. • Provided ongoing site management support to site and study team from start-up through project completion.

Site Management Coordinator

• Jul 2005 - Mar 2008

• Instrumental in the development and growth of the Site Management Department. • Assisted in developing and maintaining departmental Standard Operational Procedures and Guidelines. • Coordinated activities at various levels related to the daily functions associated with all phases clinical trials. • Generated and maintained trial-specific central files. • Helped maintain a site/investigator selection system/process and comprehensive investigator database. • Worked… Show more • Instrumental in the development and growth of the Site Management Department. • Assisted in developing and maintaining departmental Standard Operational Procedures and Guidelines. • Coordinated activities at various levels related to the daily functions associated with all phases clinical trials. • Generated and maintained trial-specific central files. • Helped maintain a site/investigator selection system/process and comprehensive investigator database. • Worked directly with the Clinical Site Manager, CRAs and Sponsor in identifying and screening appropriate investigative sites and ensured proper training of potential investigative sites. Designed and reviewed Confidentiality Agreements, Informed Consent Forms and Clinical Site Agreements and other study-specific agreements and templates. • Participated in the development and review of proposals and budgets • Organized and prepared trial-related material and presentations for trial-related meetings. • Collected, reviewed, and maintained regulatory documents from clinical sites. • Developed and maintained databases for tracking of regulatory documents, site payments, and other essential trial-related documents. • Provided centralized site support, communication and coordination to ensure accurate and timely completion of all contracted activities. • Facilitated general communication among the research centers, HCRI project teams, sponsors, site monitors and vendors relative to the responsibilities itemized above.

Cardiovascular Gene and Cell Therapy Program Research Assistant

• Dec 2003 - Jul 2005