Stacy Lee Email & Phone Number

Australia

Sydney, New South Wales, Australia

Primarily responsible for the planning and management of allcontracted responsibilities for assigned projects across the APAC region. Act as primary contact betweenNovotech and client, leads and oversees the execution of clinical projects inaccordance with local regulation, ICH GCP guidelines, Novotech/client SOPs and theProject Agreement to deliver the project on time and to budget. Project Manager isresponsible for the overall project deliverables, leading the internal… Show more Primarily responsible for the planning and management of allcontracted responsibilities for assigned projects across the APAC region. Act as primary contact betweenNovotech and client, leads and oversees the execution of clinical projects inaccordance with local regulation, ICH GCP guidelines, Novotech/client SOPs and theProject Agreement to deliver the project on time and to budget. Project Manager isresponsible for the overall project deliverables, leading the internal team and thefinancial performance of the project from site selectionthrough to Close out of the study including all deliverables within scope. Responsibilities also include identifying and evaluating potential risks and develop riskmanagement plans for mitigation while contributing to department process improvement initiatives.Participation in internal department system transition Show less

Sydney, New South Wales, Australia

independent end to end clinical project management of studies across APAC.Successful Sponsor audits with no more than 2 minor findings

Sydney, New South Wales, Australia

In addition to mentoring Junior CRAs and performing clinical site management duties across Australia, as a Principal CRA, additional duties entail working along-side the Project Manager to act as the APAC Regional Lead CRA - supporting the PM with, including but not limited to, Operational plan development, leading investigator/SC site telecons, review/assess CRA site visits/reports and general study management working closely with clients and vendors to meet deliverables during start up… Show more In addition to mentoring Junior CRAs and performing clinical site management duties across Australia, as a Principal CRA, additional duties entail working along-side the Project Manager to act as the APAC Regional Lead CRA - supporting the PM with, including but not limited to, Operational plan development, leading investigator/SC site telecons, review/assess CRA site visits/reports and general study management working closely with clients and vendors to meet deliverables during start up, maintenance and close out across APAC region. Show less

Sydney, Australia

End to end clinical site management.Accomplishment -* Jr. CRA mentoring* Develop/Deliver department wide training * KOL relationship maintenance * Number awards/recognition* Successful Audits

End to end clinical site management

Sydney Area, Australia

Feasibility, budget/contract negotiation, regulatory & Ethics submissions including Process development during TGA CTN notification transition.

Greater San Diego Area

I am a volunteer Panelist/Speaker for the Solutions medical career Speaker Series which is a vehicle to inform and motivate San Diego County high school students to action, helping to define career goals and plan the next steps to making them a reality. The themed evening panels, which are presented throughout the school year for any and all high school students, focus on a variety of career clusters. These dynamic moderated panels feature professionals who enthusiastically share their career… Show more I am a volunteer Panelist/Speaker for the Solutions medical career Speaker Series which is a vehicle to inform and motivate San Diego County high school students to action, helping to define career goals and plan the next steps to making them a reality. The themed evening panels, which are presented throughout the school year for any and all high school students, focus on a variety of career clusters. These dynamic moderated panels feature professionals who enthusiastically share their career path and speak directly with the students in the audience. Students leave with in-depth information and a better understanding of the road on which they may be embarking. Show less

Greater San Diego Area

End to end Clinical Site Management

Greater San Diego Area

Greater San Diego Area

Clinical Site MonitoringDedicated Partner of Amgen* Track, prepare and quality check Clinical site documents from feasibility, site start-up, maintenance and close-out.*Main point of contact for Clinical sites*Support other clinical operations staff with in-house coordination and maintenance of project documentation, clinical tracking, information retrieval, as well as general administrative functions.*Responsible for conducting day-to-day clinical/regulatory in-house… Show more Clinical Site MonitoringDedicated Partner of Amgen* Track, prepare and quality check Clinical site documents from feasibility, site start-up, maintenance and close-out.*Main point of contact for Clinical sites*Support other clinical operations staff with in-house coordination and maintenance of project documentation, clinical tracking, information retrieval, as well as general administrative functions.*Responsible for conducting day-to-day clinical/regulatory in-house study administration, collection, review, tracking and negotiation of study regulatory documents, assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.*Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.TMF QC *Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.*Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.*Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.* Led CTMS clean up Show less

*Responsible for the transcription of study data from source documents to paper or electronic Case Report Forms (CRF’s). In addition, performs verification and resolution of discrepancies within defined timelines.*Accurately logs and tracks Case Report Forms and Queries.*Track and resolve all CRF’s and query metrics *Assists Project Managers in updating all relevant study logs. *Facilitates the securing and inventorying of the study documents *Source Document… Show more *Responsible for the transcription of study data from source documents to paper or electronic Case Report Forms (CRF’s). In addition, performs verification and resolution of discrepancies within defined timelines.*Accurately logs and tracks Case Report Forms and Queries.*Track and resolve all CRF’s and query metrics *Assists Project Managers in updating all relevant study logs. *Facilitates the securing and inventorying of the study documents *Source Document QC*Interacts with sponsor representatives in conjunction with the project manager regarding data management issues.*Prepare subject source document for check in procedures *Request patient compensation checks.*Test, track and log all sponsor provided personal equipment such as BGMS, CGMS and etc.*Perform non-invasive protocol procedures such as EKG, Vital signs and etc.*Laboratory Safety reports Show less

*Human Rights Protection*Clinical Report review and Entry (i.e SAE, IND, CR, FR & etc)*Clinical Research Approval including but not limited to New Study Submittable, Protocol amendments and ICFs.*FDA 21CFR*Performed internal audit*Drafted & Signed Compliance Letter to the FDA*Drafted the Certificate of Confidentiality guide for investigators.*Experience with agencies such as NIH, FDA/CBER*Contact for CROs and Investigators through email/phone

La Jolla

Assisted in the research to study the YUCCA gene mutation in Arabidopsis vascularization. Responsibilities included but not limited to sample collection, DNA extraction, PCR and Gel Electrophoresis

Bachelor Of Science (Bs), Human Biology

Minor in Health-care/Social Issues

Study Abroad Program

Lsip Certificate, Life Science/Biotechnology

Industry recognized certification that provides cross-functional knowledge and best practices for life sciences and biotechnology. •.

Intellectual Property And Business

This intensive 3 ½-day course provides a strong foundation in licensing, enabling course attendees to use the language of IP.