Experience

Tarsus Pharmaceuticals, Inc.

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Associate Director Clinical Operations

  • Mar 2023 - Present



DELFI Diagnostics

• United States
• Biotechnology Research
• 100 - 200 Employee

• Associate Director Clinical Operations

  • Mar 2022 - Mar 2023



Exact Sciences

• United States
• Biotechnology Research
• 700 & Above Employee

• Principal Clinical Study Manager

  • Feb 2021 - Mar 2022

• Sr. Clinical Study Manager

  • Feb 2019 - Feb 2021

• Clinical Study Manager

  • Aug 2017 - Feb 2019



Covance

• United States
• Research Services
• 700 & Above Employee

• Project Manager

  • Mar 2015 - Aug 2017

  -Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services. -Serve as escalation point for Clinical Research Associate issues. -Resolve conflicts as needed. -Monitor project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations. -Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to… Show more -Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services. -Serve as escalation point for Clinical Research Associate issues. -Resolve conflicts as needed. -Monitor project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations. -Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to company requirements. -Ensure that staff assigned to project(s) adheres to professional standards and SOPs. -Enhance efficiency and quality of work performed on assigned projects. -Prepare and actively participate as operational lead in internal Project Review meetings. -Provide performance feedback of team members to respective supervisors. -Define and manage project resource needs and establish plans for key resources. -Assist in authoring required project plans, implement and monitor progress against project plans and revise as necessary. -Author and execute corrective/preventative action plans and explain/delegate to appropriate stakeholder(s). -Establish working relationships with project teams which result in operational excellence. -Prepare and deliver presentations in collaboration with relevant departments for investigator meetings and cross-functional team meetings. -Work to meet financial performance targets for assigned project(s). -Leadership responsibilities for the training, and development of assigned staff. -Global study management.

• Associate Project Manager

  • Jan 2014 - Mar 2015

• Lead/Sr. CRA Early Clinical Development Oncology

  • Sep 2012 - Jan 2014

  1) Provide site management activities for research protocols. 2) Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and GCP/ICH guidelines. 3) Evaluate the quality and integrity of study site practices related to the conduct of the protocol and adherence to applicable regulations. 4) Administer protocol education to clinical sites. 5) Establish and maintain strong lines of communication to manage… Show more 1) Provide site management activities for research protocols. 2) Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and GCP/ICH guidelines. 3) Evaluate the quality and integrity of study site practices related to the conduct of the protocol and adherence to applicable regulations. 4) Administer protocol education to clinical sites. 5) Establish and maintain strong lines of communication to manage ongoing screening, recruitment, project expectations, issues, and quality. 6) Manage the progress of clinical sites by tracking regulatory submissions and approvals, recruitment and enrollment, study drug accountability and drug order review, source document review, case report form completion and submission, and data clarifications of all study data in study database. 7) Create and maintain documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports. 8) Manage and support sites in milestone achievements, issues and obstacles. 9) Escalate issues and obstacles as appropriate and execute action plans.



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Sr. CRA

  • Sep 2008 - Sep 2012

  1) Provide site management activities for research protocols. 2) Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and GCP/ICH guidelines. 3) Evaluate the quality and integrity of study site practices related to the conduct of the protocol and adherence to applicable regulations. 4) Administer protocol education to clinical sites. 5) Establish and maintain strong lines of communication to manage… Show more 1) Provide site management activities for research protocols. 2) Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and GCP/ICH guidelines. 3) Evaluate the quality and integrity of study site practices related to the conduct of the protocol and adherence to applicable regulations. 4) Administer protocol education to clinical sites. 5) Establish and maintain strong lines of communication to manage ongoing screening, recruitment, project expectations, issues, and quality. 6) Manage the progress of clinical sites by tracking regulatory submissions and approvals, recruitment and enrollment, study drug accountability and drug order review, source document review, case report form completion and submission, and data clarifications of all study data in study database. 7) Create and maintain documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports. 8) Manage and support sites in milestone achievements, issues and obstacles. 9) Escalate issues and obstacles as appropriate and execute action plans. Show less 1) Provide site management activities for research protocols. 2) Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and GCP/ICH guidelines. 3) Evaluate the quality and integrity of study site practices related to the conduct of the protocol and adherence to applicable regulations. 4) Administer protocol education to clinical sites. 5) Establish and maintain strong lines of communication to manage… Show more 1) Provide site management activities for research protocols. 2) Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and GCP/ICH guidelines. 3) Evaluate the quality and integrity of study site practices related to the conduct of the protocol and adherence to applicable regulations. 4) Administer protocol education to clinical sites. 5) Establish and maintain strong lines of communication to manage ongoing screening, recruitment, project expectations, issues, and quality. 6) Manage the progress of clinical sites by tracking regulatory submissions and approvals, recruitment and enrollment, study drug accountability and drug order review, source document review, case report form completion and submission, and data clarifications of all study data in study database. 7) Create and maintain documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports. 8) Manage and support sites in milestone achievements, issues and obstacles. 9) Escalate issues and obstacles as appropriate and execute action plans. Show less



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Clinical Trial Specialist/Clinical Trial Associate

  • Jan 2006 - Sep 2008

  1) Assisted in the management of clinical trials and projects. 2) Coordinated and administered cross-functional deliverables with internal functional groups. 3) Conducted study feasibility and identification of clinical trial investigators. 4) Experience in preparation and conduct of monitors’ workshops and investigators’ meetings. 5) Supported site monitors with site management and electronic data capture. 6) Vendor Management including SMOs, IVRS… Show more 1) Assisted in the management of clinical trials and projects. 2) Coordinated and administered cross-functional deliverables with internal functional groups. 3) Conducted study feasibility and identification of clinical trial investigators. 4) Experience in preparation and conduct of monitors’ workshops and investigators’ meetings. 5) Supported site monitors with site management and electronic data capture. 6) Vendor Management including SMOs, IVRS, home-care, central IRBs and laboratories. 7) Reviewed informed consent forms for compliance with regulations and protocol content. 8) Tracked and identified study trends to report to management. 9) Performed quality review of subject narratives, study reports, BLA submission, and regulatory documents. Show less 1) Assisted in the management of clinical trials and projects. 2) Coordinated and administered cross-functional deliverables with internal functional groups. 3) Conducted study feasibility and identification of clinical trial investigators. 4) Experience in preparation and conduct of monitors’ workshops and investigators’ meetings. 5) Supported site monitors with site management and electronic data capture. 6) Vendor Management including SMOs, IVRS… Show more 1) Assisted in the management of clinical trials and projects. 2) Coordinated and administered cross-functional deliverables with internal functional groups. 3) Conducted study feasibility and identification of clinical trial investigators. 4) Experience in preparation and conduct of monitors’ workshops and investigators’ meetings. 5) Supported site monitors with site management and electronic data capture. 6) Vendor Management including SMOs, IVRS, home-care, central IRBs and laboratories. 7) Reviewed informed consent forms for compliance with regulations and protocol content. 8) Tracked and identified study trends to report to management. 9) Performed quality review of subject narratives, study reports, BLA submission, and regulatory documents. Show less



Children's Hospital Los Angeles (CHLA)

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Institutonal Review Board Administrator

  • Jul 2005 - Jan 2006