Senior Clinical Project Manager

• Jun 2022 - Present

Clinical Project Manager

• Oct 2020 - Jun 2022

Clinical Trial Management Consultant

• Jun 2020 - Oct 2020

Reporting to the Senior vice President, Clinical Development, conducted review of clinical trial CRO bid proposals, and review of clinical trial protocols. Reporting to the Senior vice President, Clinical Development, conducted review of clinical trial CRO bid proposals, and review of clinical trial protocols.

Consulting Clinical Trial Manager

• Jan 2020 - Jun 2020

Provided project management support to the conduct of the Freedom-1 Trial in accordance with ICH-GCP and Federal guidelines. • Conducted SOP Gap Analysis and initiated development of sponsor clinical GCP • Developed study specific training matrices and rolled out CRO SOP training to the broader organization • Finalized internal team training matrix and initiated internal SOP training • Worked closely with manufacturing to identify gaps in site training, and training materials, and… Show more Provided project management support to the conduct of the Freedom-1 Trial in accordance with ICH-GCP and Federal guidelines. • Conducted SOP Gap Analysis and initiated development of sponsor clinical GCP • Developed study specific training matrices and rolled out CRO SOP training to the broader organization • Finalized internal team training matrix and initiated internal SOP training • Worked closely with manufacturing to identify gaps in site training, and training materials, and worked to remediate all training • Led the development and cross-functional review of significant protocol amendment, including the addition of Covid-19 related tasks and procedures • Review of site Informed Consent Forms and Essential Documents prior to site activation • Management of multiple vendors including Central Lab, Drug Depot, Home Health, and Subject Travel • Led cross-functional review of the Clinical Monitoring • Revised the study start-up materials including the ISF table of contents, and controlled document versioning tracker • Developed multiple tools and trackers to facilitate to manage both ongoing clinical studies, as well as track the disposition of multiple legacy studies conducted by Talaris and its predecessors • Actively participated in team meetings, including setting the agenda and taking meeting minutes as needed • Consolidated study documentation for multiple phase 1 and 2 legacy studies Show less Provided project management support to the conduct of the Freedom-1 Trial in accordance with ICH-GCP and Federal guidelines. • Conducted SOP Gap Analysis and initiated development of sponsor clinical GCP • Developed study specific training matrices and rolled out CRO SOP training to the broader organization • Finalized internal team training matrix and initiated internal SOP training • Worked closely with manufacturing to identify gaps in site training, and training materials, and… Show more Provided project management support to the conduct of the Freedom-1 Trial in accordance with ICH-GCP and Federal guidelines. • Conducted SOP Gap Analysis and initiated development of sponsor clinical GCP • Developed study specific training matrices and rolled out CRO SOP training to the broader organization • Finalized internal team training matrix and initiated internal SOP training • Worked closely with manufacturing to identify gaps in site training, and training materials, and worked to remediate all training • Led the development and cross-functional review of significant protocol amendment, including the addition of Covid-19 related tasks and procedures • Review of site Informed Consent Forms and Essential Documents prior to site activation • Management of multiple vendors including Central Lab, Drug Depot, Home Health, and Subject Travel • Led cross-functional review of the Clinical Monitoring • Revised the study start-up materials including the ISF table of contents, and controlled document versioning tracker • Developed multiple tools and trackers to facilitate to manage both ongoing clinical studies, as well as track the disposition of multiple legacy studies conducted by Talaris and its predecessors • Actively participated in team meetings, including setting the agenda and taking meeting minutes as needed • Consolidated study documentation for multiple phase 1 and 2 legacy studies Show less

Associate Clinical Project Manager

• Jul 2019 - Oct 2019

Under the direction of the Senior Director, Clinical Project Management and Monitoring, was a key contributor in the Phase3 Parkinson’s Disease Program, which led to successful 505(b)(2) submission and FDA approval for INBRIJA™ (levodopa inhalation powder) drug/devise combination product, as well as the successful MMA filing and approval in the EU. Provided project management support to the conduct of the CVT-301 Parkinson’s Disease program in accordance with ICH GCP, Federal, and… Show more Under the direction of the Senior Director, Clinical Project Management and Monitoring, was a key contributor in the Phase3 Parkinson’s Disease Program, which led to successful 505(b)(2) submission and FDA approval for INBRIJA™ (levodopa inhalation powder) drug/devise combination product, as well as the successful MMA filing and approval in the EU. Provided project management support to the conduct of the CVT-301 Parkinson’s Disease program in accordance with ICH GCP, Federal, and International guidelines, including multiple phase 3, and post marketing phase 1 clinical trials in the US, Canada, UK, and EU. • Performs all aspects of clinical trial management, specializing in: o Management and oversight of Contract Research Organizations (CROs) and other vendors o SOP Gap Analysis o Site Selection and Feasibility o Site Budget and Contract Negotiation o Review of essential documents, investigational product release, and maintenance and review of electronic trial master file (eTMF) o Site management and oversight of site initiation, training, and close-out, including developing training tools, slide decks, and source documents o Review and management of clinical research associates (CRAs), monitoring visit reports, and monitoring oversite/CRA evaluation visits, including developing Clinical Monitoring Plans in accordance with ICG E6(R2) ● Assisted in the redevelopment of Site Management and Monitoring SOPs and WIs ● Assisted in upgrade to Siebel CTMS including drafting new monitoring documents, and UAT ● Subject matter expert (SME) and liaison to Quality Assurance department in Site and Vendor GCP audits o Review of Essential Documents and Source Data Verification o Participated in multiple site, vendor, and internal audits, including FDA and EMA Inspection Readiness visits, and FDA site inspections

Senior Clinical Trial Associate

• Jul 2015 - Jul 2019

• Acted as Lead CRA through multiple Phase 1 PK studies, managing multiple CRAs and performing oversight and evaluation visits • Developed source documents for Phase 1 PK study, including developing a template for future studies • Managed financial accruals with multiple vendors, reporting to the finance department on a monthly basis • Performed Monitoring Visit Report Review, and oversight of CRO contracted CRAs through co-monitoring and evaluation visits • Performed quality… Show more • Acted as Lead CRA through multiple Phase 1 PK studies, managing multiple CRAs and performing oversight and evaluation visits • Developed source documents for Phase 1 PK study, including developing a template for future studies • Managed financial accruals with multiple vendors, reporting to the finance department on a monthly basis • Performed Monitoring Visit Report Review, and oversight of CRO contracted CRAs through co-monitoring and evaluation visits • Performed quality reviews of eTMF for Phase 3 studies • Provided quality metrics to the Clinical Operations Team • Reviewed Site Essential Documents prior to IP Release and Site Activation • Participated in Clinical Operations Team meetings, including taking meeting minutes as needed

Clinical Research Coordinator (Research Assistant II)

• May 2013 - May 2015

Under the direction of the Unit Operations Director and Medical Director conducts clinical research is a high volume, dedicated research division, conducting both government (NIH) and privately sponsored clinical research studies and trials in accordance with GCP, ICH, and federal guidelines  Lead clinical research coordinator of the “Optimizing Protein in Older Americans with Mobility Limitations” (OPTIMen) Study, a single site Phase-III, 2x2 factorial clinical trial evaluating whether… Show more Under the direction of the Unit Operations Director and Medical Director conducts clinical research is a high volume, dedicated research division, conducting both government (NIH) and privately sponsored clinical research studies and trials in accordance with GCP, ICH, and federal guidelines  Lead clinical research coordinator of the “Optimizing Protein in Older Americans with Mobility Limitations” (OPTIMen) Study, a single site Phase-III, 2x2 factorial clinical trial evaluating whether weekly injections of a low dose testosterone supplement, and/or an increase in dietary protein intake will improve muscle mass, strength and physical function in older men. • Conduct of Clinical Research under GCP and ICH guidelines • Recruitment of study subjects, telephone screening, in person consent and screening/interviewing of subjects • Conduct baseline, randomization, and follow up study visits • Administer questionnaires, collect vital statistics, perform basic physical function assessments • Maintain database and logs of screened, enrolled, and randomized participants • Preparation of weekly recruitment reports, data entry, data quality control • Preparation and maintenance of Institutional Review Board and Regulatory documents • Oversight of research team of research assistants and student interns  Co-coordinator of the “Testosterone Trial” (T-Trial) a multi-center study of 6 coordinated trials of the effects of testosterone in elderly men with low testosterone on physical function, vitality, sexual function, cognitive function, anemia, and cardiovascular risk.  Maintain and update census based mailing lists for surrounding suburbs and Eastern Massachusetts  Assists in the training of junior research assistants and student interns This is a direct continuation of the position at Boston Medical Center, which moved with the entire department in May 2013. Show less Under the direction of the Unit Operations Director and Medical Director conducts clinical research is a high volume, dedicated research division, conducting both government (NIH) and privately sponsored clinical research studies and trials in accordance with GCP, ICH, and federal guidelines  Lead clinical research coordinator of the “Optimizing Protein in Older Americans with Mobility Limitations” (OPTIMen) Study, a single site Phase-III, 2x2 factorial clinical trial evaluating whether… Show more Under the direction of the Unit Operations Director and Medical Director conducts clinical research is a high volume, dedicated research division, conducting both government (NIH) and privately sponsored clinical research studies and trials in accordance with GCP, ICH, and federal guidelines  Lead clinical research coordinator of the “Optimizing Protein in Older Americans with Mobility Limitations” (OPTIMen) Study, a single site Phase-III, 2x2 factorial clinical trial evaluating whether weekly injections of a low dose testosterone supplement, and/or an increase in dietary protein intake will improve muscle mass, strength and physical function in older men. • Conduct of Clinical Research under GCP and ICH guidelines • Recruitment of study subjects, telephone screening, in person consent and screening/interviewing of subjects • Conduct baseline, randomization, and follow up study visits • Administer questionnaires, collect vital statistics, perform basic physical function assessments • Maintain database and logs of screened, enrolled, and randomized participants • Preparation of weekly recruitment reports, data entry, data quality control • Preparation and maintenance of Institutional Review Board and Regulatory documents • Oversight of research team of research assistants and student interns  Co-coordinator of the “Testosterone Trial” (T-Trial) a multi-center study of 6 coordinated trials of the effects of testosterone in elderly men with low testosterone on physical function, vitality, sexual function, cognitive function, anemia, and cardiovascular risk.  Maintain and update census based mailing lists for surrounding suburbs and Eastern Massachusetts  Assists in the training of junior research assistants and student interns This is a direct continuation of the position at Boston Medical Center, which moved with the entire department in May 2013. Show less

Clinical Research Assistant/Clinical Research Coordinator

• Jan 2012 - May 2013

Research assistant on the OPTIMen clinical research study, a single center, 2x2 factoral, randomized, double blind study of men 65 yrs+ and testosterone replacement therapy and a healthy, high protein diet. Research assistant/Co-Coordinator on the T-Trial, a national multi-site, 5 arm, randomized, double blind study of men 65 yrs+ and Testosterone replacement therapy. Research assistant on the OPTIMen clinical research study, a single center, 2x2 factoral, randomized, double blind study of men 65 yrs+ and testosterone replacement therapy and a healthy, high protein diet. Research assistant/Co-Coordinator on the T-Trial, a national multi-site, 5 arm, randomized, double blind study of men 65 yrs+ and Testosterone replacement therapy.

Ophthalmic Medical Technician

• Apr 2008 - Dec 2011

As part of a team of ophthalmic medical technicians, assisted ophthalmologists in performance of routine and comprehensive eye exams in a medium sized, busy private comprehensive ophthalmology practice • Conducted initial contact with patients obtaining patient health histories, visual acuity screening, color blindness screening, basic refractions, Goldmann tonometry, keratotomy, corneal pachymetry, corneal topography, Humphrey Visual Field screenings, Optical Coherence Tomography (OCT) •… Show more As part of a team of ophthalmic medical technicians, assisted ophthalmologists in performance of routine and comprehensive eye exams in a medium sized, busy private comprehensive ophthalmology practice • Conducted initial contact with patients obtaining patient health histories, visual acuity screening, color blindness screening, basic refractions, Goldmann tonometry, keratotomy, corneal pachymetry, corneal topography, Humphrey Visual Field screenings, Optical Coherence Tomography (OCT) • Under the direction of the practice physician, administered ophthalmic topical medications, trained patients in proper use of eye drops, eye scrubs, contact lenses, and other at home ophthalmic procedures • Assisted physicians in in-office surgical procedures, aseptic-room techniques • Use of both tradition hand written patients charts as well as electronic medical records • Understanding of ICD-9 diagnosis codes, and CPT procedure codes Show less As part of a team of ophthalmic medical technicians, assisted ophthalmologists in performance of routine and comprehensive eye exams in a medium sized, busy private comprehensive ophthalmology practice • Conducted initial contact with patients obtaining patient health histories, visual acuity screening, color blindness screening, basic refractions, Goldmann tonometry, keratotomy, corneal pachymetry, corneal topography, Humphrey Visual Field screenings, Optical Coherence Tomography (OCT) •… Show more As part of a team of ophthalmic medical technicians, assisted ophthalmologists in performance of routine and comprehensive eye exams in a medium sized, busy private comprehensive ophthalmology practice • Conducted initial contact with patients obtaining patient health histories, visual acuity screening, color blindness screening, basic refractions, Goldmann tonometry, keratotomy, corneal pachymetry, corneal topography, Humphrey Visual Field screenings, Optical Coherence Tomography (OCT) • Under the direction of the practice physician, administered ophthalmic topical medications, trained patients in proper use of eye drops, eye scrubs, contact lenses, and other at home ophthalmic procedures • Assisted physicians in in-office surgical procedures, aseptic-room techniques • Use of both tradition hand written patients charts as well as electronic medical records • Understanding of ICD-9 diagnosis codes, and CPT procedure codes Show less

Ophthalmic Medical Assistant

• Apr 2004 - Aug 2006

Assisted Ophthalmologists in performance of routine and comprehensive eye exams in a small private general ophthalmology practice • Conducted initial contact with patients obtaining patient health histories, visual acuity screening, color blindness screening, basic refractions, keratotomy, corneal pachymetry, corneal topography, A-Scans, and Humphrey Visual Field screenings • Under the direction of the practice physician, administered ophthalmic topical medications, trained patients in… Show more Assisted Ophthalmologists in performance of routine and comprehensive eye exams in a small private general ophthalmology practice • Conducted initial contact with patients obtaining patient health histories, visual acuity screening, color blindness screening, basic refractions, keratotomy, corneal pachymetry, corneal topography, A-Scans, and Humphrey Visual Field screenings • Under the direction of the practice physician, administered ophthalmic topical medications, trained patients in proper use of eye drops, eye scrubs, contact lenses, and other at home ophthalmic procedures • Assisted physicians in in-office surgical procedures, aseptic-room techniques • Coordinated with local out-patient surgical centers, surgeons, and patients for scheduling ophthalmic procedures • Understanding of ICD-9 diagnosis codes, and CPT procedure codes Show less Assisted Ophthalmologists in performance of routine and comprehensive eye exams in a small private general ophthalmology practice • Conducted initial contact with patients obtaining patient health histories, visual acuity screening, color blindness screening, basic refractions, keratotomy, corneal pachymetry, corneal topography, A-Scans, and Humphrey Visual Field screenings • Under the direction of the practice physician, administered ophthalmic topical medications, trained patients in… Show more Assisted Ophthalmologists in performance of routine and comprehensive eye exams in a small private general ophthalmology practice • Conducted initial contact with patients obtaining patient health histories, visual acuity screening, color blindness screening, basic refractions, keratotomy, corneal pachymetry, corneal topography, A-Scans, and Humphrey Visual Field screenings • Under the direction of the practice physician, administered ophthalmic topical medications, trained patients in proper use of eye drops, eye scrubs, contact lenses, and other at home ophthalmic procedures • Assisted physicians in in-office surgical procedures, aseptic-room techniques • Coordinated with local out-patient surgical centers, surgeons, and patients for scheduling ophthalmic procedures • Understanding of ICD-9 diagnosis codes, and CPT procedure codes Show less