Senior Contract Manager

• Mar 2021 - Present

Contracts Manager

• Mar 2019 - Present

Associate Contracts Manager

• Oct 2017 - Mar 2019

Contract Administrator

• Aug 2016 - Sep 2017

• Drafted, reviewed, and assisted with the negotiation of Confidentiality Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs) and vendor work orders • Assisted in the filing of all executed agreements on Akebia's SharePoint site, and kept up with regular correspondence from CROs and vendors to ensure the finalization of the contracts and budgets • Managed the signature process internally at Akebia • Remitted signature copies to sites via email and post, following up… Show more • Drafted, reviewed, and assisted with the negotiation of Confidentiality Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs) and vendor work orders • Assisted in the filing of all executed agreements on Akebia's SharePoint site, and kept up with regular correspondence from CROs and vendors to ensure the finalization of the contracts and budgets • Managed the signature process internally at Akebia • Remitted signature copies to sites via email and post, following up regularly • Maintained a tracker ensuring the accurate statuses of contracts was captured at all times • Filed fully executed copies of agreements internally and with CROs • Attended regular calls with CROs in order to provide vendor oversight and ensure that contracts were moving along smoothly and were on track for full execution Show less • Drafted, reviewed, and assisted with the negotiation of Confidentiality Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs) and vendor work orders • Assisted in the filing of all executed agreements on Akebia's SharePoint site, and kept up with regular correspondence from CROs and vendors to ensure the finalization of the contracts and budgets • Managed the signature process internally at Akebia • Remitted signature copies to sites via email and post, following up… Show more • Drafted, reviewed, and assisted with the negotiation of Confidentiality Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs) and vendor work orders • Assisted in the filing of all executed agreements on Akebia's SharePoint site, and kept up with regular correspondence from CROs and vendors to ensure the finalization of the contracts and budgets • Managed the signature process internally at Akebia • Remitted signature copies to sites via email and post, following up regularly • Maintained a tracker ensuring the accurate statuses of contracts was captured at all times • Filed fully executed copies of agreements internally and with CROs • Attended regular calls with CROs in order to provide vendor oversight and ensure that contracts were moving along smoothly and were on track for full execution Show less

Contracts Associate

• Apr 2015 - Aug 2016

• Drafted and negotiated Health Care Professional (HCP) consulting agreements, Master Clinical Trail Agreements (MCTAs), Power of Attorney (POAs) and Confidentiality Disclosure Agreements (CDAs) • Reviewed and helped negotiate legal and financial changes proposed by the consultant or vendor • Tiered HCP CVs in order to calculate the proper Fair Market Value (FMV) rate • Calculated the FMV for each HCP consulting agreement • Raised Purchase Orders in Oracle and facilitated new… Show more • Drafted and negotiated Health Care Professional (HCP) consulting agreements, Master Clinical Trail Agreements (MCTAs), Power of Attorney (POAs) and Confidentiality Disclosure Agreements (CDAs) • Reviewed and helped negotiate legal and financial changes proposed by the consultant or vendor • Tiered HCP CVs in order to calculate the proper Fair Market Value (FMV) rate • Calculated the FMV for each HCP consulting agreement • Raised Purchase Orders in Oracle and facilitated new supplier setup with finance (as applicable) • Created placeholders/uploaded of fully executed contracts to contracts repository (SELECTICA) • Kept stakeholders apprised of contract negotiation progress through completion of trackers/reports

Clinical Trial Coordinator

• Sep 2014 - Apr 2015

• Supported the study team in the successful execution of assigned clinical trials from protocol concept through to clinical study report, in compliance with international GCP guidelines/regulations and Standard Operating Procedures (SOPs) • Coordinated CDA preparation, collection and execution • Distributed, collected and reviewed Financial Disclosures • Set-up, updated and maintained the clinical trial management system e.g. IMPACT • Subject Matter Expert in Biogen's CTMS system… Show more • Supported the study team in the successful execution of assigned clinical trials from protocol concept through to clinical study report, in compliance with international GCP guidelines/regulations and Standard Operating Procedures (SOPs) • Coordinated CDA preparation, collection and execution • Distributed, collected and reviewed Financial Disclosures • Set-up, updated and maintained the clinical trial management system e.g. IMPACT • Subject Matter Expert in Biogen's CTMS system for the inVentiv CTC group; performed new hire trainings and ongoing Q&A education sessions • Created, reviewed, approved, distributed and tracked Site Reference Materials e.g. Study Manual, Pharmacy Manual, Regulatory / Investigator Binder • Prepared and maintained Insurance certificates • Managed, and reviewed drug shipment, destruction, and return • Coordinated internal lab sample supply set up and shipment; assisted with sample queries • Participated in study design and execution by contributing operational experience and expertise; Provided input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications • Tracked protocol deviations • Populated, distributed, reviewed and tracked all essential documents throughout the study • Managed temperature excursions • SUSAR coordination • Created and maintained VCTR, Biogen’s CT.gov registry platform • Supported audit/inspection readiness; Kept R&D Compliance updated with changes to site list and timelines for audit planning • Tracked study visits (for budget purposes) with CRO & EDC • Ensured CCF completion and quality • Coordinated the final transfer of the CCF from the CRO(s)

Site Management Specialist

• Oct 2013 - Sep 2014

• Assisted with the development of materials for and performs essential document collection and tracking, technical support, pre-study, study initiation, remote monitoring, site management, and close-out activities via telephone while adhering to all applicable regulatory and SOPs and Project Plans • Performed in-house site support activities, researching and responding to various site inquiries, and appropriately documenting these interactions • Assisted and supported study start-up… Show more • Assisted with the development of materials for and performs essential document collection and tracking, technical support, pre-study, study initiation, remote monitoring, site management, and close-out activities via telephone while adhering to all applicable regulatory and SOPs and Project Plans • Performed in-house site support activities, researching and responding to various site inquiries, and appropriately documenting these interactions • Assisted and supported study start-up activities, including the review of clinical and project-related documents (i.e. protocol, case report form, Informed Consent, monitoring plan, site recruitment plan, source documents, training manuals, study binders, patient contact material, etc.) • Performed comprehensive trainings on the EDC with sites • Adhered to a schedule of project-related communications and activities and effectively documented these communications for tracking purposes • Provided administrative support by preparing, organizing, managing, and tracking registry supplies. • Identified potential problems and implements corrective actions • Performed the following data management activities: direct data entry from telephone interviews, CRF routing, data reviewing, querying, and updating • Assisted in the development of patient enrollment strategies • Provided support for study awareness, patient recruitment, and investigative site activities • Conducted outbound telephone calls, including administration of patient assessment tools and acquisition of study documents • Utilized the clinical trail management system (CTMS) to track and manage site/client contacts, patient enrollment, and other registry-specific reports, and provide reports to Project Management/CRAs/client • Attended and presented the status of site management activities at project team and client meetings • Investigated, tracked, prioritized, and resolved site/client user feedback, complaints and issues Show less • Assisted with the development of materials for and performs essential document collection and tracking, technical support, pre-study, study initiation, remote monitoring, site management, and close-out activities via telephone while adhering to all applicable regulatory and SOPs and Project Plans • Performed in-house site support activities, researching and responding to various site inquiries, and appropriately documenting these interactions • Assisted and supported study start-up… Show more • Assisted with the development of materials for and performs essential document collection and tracking, technical support, pre-study, study initiation, remote monitoring, site management, and close-out activities via telephone while adhering to all applicable regulatory and SOPs and Project Plans • Performed in-house site support activities, researching and responding to various site inquiries, and appropriately documenting these interactions • Assisted and supported study start-up activities, including the review of clinical and project-related documents (i.e. protocol, case report form, Informed Consent, monitoring plan, site recruitment plan, source documents, training manuals, study binders, patient contact material, etc.) • Performed comprehensive trainings on the EDC with sites • Adhered to a schedule of project-related communications and activities and effectively documented these communications for tracking purposes • Provided administrative support by preparing, organizing, managing, and tracking registry supplies. • Identified potential problems and implements corrective actions • Performed the following data management activities: direct data entry from telephone interviews, CRF routing, data reviewing, querying, and updating • Assisted in the development of patient enrollment strategies • Provided support for study awareness, patient recruitment, and investigative site activities • Conducted outbound telephone calls, including administration of patient assessment tools and acquisition of study documents • Utilized the clinical trail management system (CTMS) to track and manage site/client contacts, patient enrollment, and other registry-specific reports, and provide reports to Project Management/CRAs/client • Attended and presented the status of site management activities at project team and client meetings • Investigated, tracked, prioritized, and resolved site/client user feedback, complaints and issues Show less

Senior Clinical Research Associate

• May 2011 - Oct 2013

• Assisted with hiring, mentoring and training new employees • Aided Program Manager with regulatory documents required for clinical trial initiation • Collaborated with pharmaceutical companies to coordinate, plan and schedule Site Initiation Visits (SIVs) prior to study activation • Provided facility tours to pharmaceutical company representatives at the time of the SIV • Trained and presented new protocols and protocol amendments and updates to the Gynecological Oncology study… Show more • Assisted with hiring, mentoring and training new employees • Aided Program Manager with regulatory documents required for clinical trial initiation • Collaborated with pharmaceutical companies to coordinate, plan and schedule Site Initiation Visits (SIVs) prior to study activation • Provided facility tours to pharmaceutical company representatives at the time of the SIV • Trained and presented new protocols and protocol amendments and updates to the Gynecological Oncology study team • Tracked to ensure invoices were being issued to sponsors by the finance team at appropriate study time points • Prepared presentations for activation and amendment training on internally regulated protocols • Assisted in editing and improving Standard Operating Procedure (SOP) documents for Cancer Center Protocol Office and Dana Farber Harvard Cancer Center • Assembled, organized, maintained and disseminated a list of all open clinical trials on site to study team members which highlighted key eligibility criteria for each study

Clinical Research Associate

• May 2010 - Oct 2013

• Coordinated, manage data, and maintained key regulatory documents for Phase I, II and III therapeutic clinical trials for the gynecological oncology program • Communicated with clinical investigators, research nurses, and patients to ensure investigational assessments are completed as mandated by the clinical trial protocol • Ensured potential clinical trial participants met eligibility criteria prior to enrollment on study • Acted as liaison between pharmaceutical companies… Show more • Coordinated, manage data, and maintained key regulatory documents for Phase I, II and III therapeutic clinical trials for the gynecological oncology program • Communicated with clinical investigators, research nurses, and patients to ensure investigational assessments are completed as mandated by the clinical trial protocol • Ensured potential clinical trial participants met eligibility criteria prior to enrollment on study • Acted as liaison between pharmaceutical companies, investigators, and CROs • Reviewed cases with investigators to determine discrepancies • Prepared regulatory documents for the IRB and FDA involved in human research protocols, including adverse event reports, annual reviews and protocol amendments • Assembled, managed and maintained regulatory files and electronic regulatory files for each clinical trial • Ensured all clinical trial team members had proper training on each trial. Created, collected, filed and maintained documentation of initial training as well as training on major protocol amendments for each team member • Abided by Good Clinical Practice guidelines and followed hospital SOPs

Pharmacy Application Specialist

• Aug 2009 - May 2010

• Troubleshot, researched, and solved customer software and system problems • Acted as the primary contact for clients • Processed requests for software enhancements and system modifications • Provided customer education, both internally and at customer sites • Troubleshot, researched, and solved customer software and system problems • Acted as the primary contact for clients • Processed requests for software enhancements and system modifications • Provided customer education, both internally and at customer sites