Experience

Repare Therapeutics

• Canada
• Biotechnology Research
• 100 - 200 Employee

• Senior Manager, Clinical Biomarker Operations

  • Nov 2021 - Present

  Cambridge, Massachusetts, United States



Agenus

• United States
• Biotechnology Research
• 200 - 300 Employee

• Senior Project Manager, Biomarkers

  • Feb 2021 - Nov 2021

  • Partner with Clinical Operations Team to ensure effective and timely communication to cross-functional teams and senior management regarding program deliverables, key milestones, achievement of external and internal commitments, timelines, budgets, and key events. • Work cross functionally to set, monitor, and control key performance indicators, risks, change management and communication tools across all clinical programs. • Prepare and Manage $40M clinical trials biomarker budgets by… Show more • Partner with Clinical Operations Team to ensure effective and timely communication to cross-functional teams and senior management regarding program deliverables, key milestones, achievement of external and internal commitments, timelines, budgets, and key events. • Work cross functionally to set, monitor, and control key performance indicators, risks, change management and communication tools across all clinical programs. • Prepare and Manage $40M clinical trials biomarker budgets by monitoring expenditures, calculating forecasts, and ensuring compliance. • Develop, manage, and oversee clinical biomarkers operations activities, timelines, metrics, and quality standards [ICH/GCP/SOPs] across all clinical studies (Phase I – III) in collaboration with study team members/functions. • Monitor timelines and ensure delivery of Biomarker/PK/ADA data required for BLA submission and other study specific timelines. • Work cross functionally to assess the status of each clinical trial from the perspective of inspection readiness, and identify, track and resolve any issues to bring the study to a state of ‘inspection readiness’. • Mentor, supervise, assign tasks and delegate appropriately increasing levels of responsibility to qualified direct/indirect reports. • Drive assessment, management, and oversight of clinical study vendors, including Central labs and CROs. • Lead, plan and execute effective clinical vendor meetings. • Implement solutions internally and with Central labs, CROs, and Clinical sites to help streamline processes. • Cultivate relationships and ensure effective communication between internal team and external stakeholders. • Collaborate with QA team and other functions towards the continued evolution of the Quality Management System (QMS), execution of risk-based management solutions and development of controlled documentation. • Ensure study risks are proactively identified, managed, and mitigation strategies are implemented cross-functionally.

• Biomarker Project Manager

  • Apr 2019 - Feb 2021

  • Coordinate with scientists and other internal functions to develop timelines for obtaining clinical biomarker data. • Establish and submit vendor contracts for all clinical trials sample testing. • Coordinate and monitor Contract Research Organizations (CROs) in collaboration with Clinical Operations to develop and communicate plans and schedules to ensure that clinical samples are shipped appropriately and according to schedule for all clinical trials. • Sample collection… Show more • Coordinate with scientists and other internal functions to develop timelines for obtaining clinical biomarker data. • Establish and submit vendor contracts for all clinical trials sample testing. • Coordinate and monitor Contract Research Organizations (CROs) in collaboration with Clinical Operations to develop and communicate plans and schedules to ensure that clinical samples are shipped appropriately and according to schedule for all clinical trials. • Sample collection surveillance across all clinical trials. • Closely monitor Central Labs’ sample management database for discrepancies. • Investigate and resolve sample discrepancies with central lab services. • Coordinate with CROs to develop timelines and monitor timely analysis of clinical samples, and data transfer and reconciliation in collaboration with data management team. • Manage and monitor laboratory sites to ensure that assay validation protocols are being followed and clinical samples are analyzed according to Good Clinical Practice Guidelines. • Select and manage CROs and other clinical third-party vendors as needed. • Create and manage the timelines to meet the goals and objectives per clinical study. • Assist in the development of GCP audit schedule of critical laboratory vendors. • Engage in vendor audits as the subject matter expert, contribute to audit agenda, review vendor SOPs, document and report findings to QA team member and assist in final audit report preparation. • Support company goals and objectives, policies and procedures, performance management programs. • Research vendors to find the best products/services and prices available within a given market. • Conduct interviews and meetings with new vendors. • Negotiate new and existing vendor contracts. • Aid in preparing and overseeing vendor contracts. • Cultivate and maintain relationships with vendors by communicating with them frequently to answer questions and check their satisfaction levels.

• Translational Medicine Coordinator/Research Associate

  • Jan 2019 - Apr 2019

  Lexington, Massachusetts · Coordinate with scientists and other internal functions to develop timelines for obtaining clinical data · Coordinate with Contract Research Organizations and Clinical Operations to develop and communicate plans and schedules to ship samples from clinical sites to Contract Research Organizations · Coordinate with and monitor Contract Research Organizations to ensure that clinical samples are shipped appropriately and according to schedule · Coordinate with… Show more · Coordinate with scientists and other internal functions to develop timelines for obtaining clinical data · Coordinate with Contract Research Organizations and Clinical Operations to develop and communicate plans and schedules to ship samples from clinical sites to Contract Research Organizations · Coordinate with and monitor Contract Research Organizations to ensure that clinical samples are shipped appropriately and according to schedule · Coordinate with Contract Research Organizations to develop timelines for the analysis of clinical samples · Monitor Contract Research Organizations to ensure the regular and timely analysis of clinical samples, and transfer of data at appropriate intervals · Address any issues relating to Contract Research Organizations as they arise · Coordinate with Data Management and Contract Research Organizations to ensure that data is appropriately reconciled · Analyze data as it is received internally to answer relevant scientific questions pertaining to drug mechanism of action, and pharmacokinetic and pharmacodynamic biomarkers · Generate figures to communicate scientific results internally · Communicate scientific results externally by contributing to posters and journal publications



Abiomed

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Clinical Data Specialist

  • Jan 2018 - Sep 2018

  • Medical record and research source documentation verification against case report form data, • Informing site staff of any entry errors. • Ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements. • Provide high-quality data by keeping the number of errors and missing data as low as possible and gather maximum data for analysis • Supervise the… Show more • Medical record and research source documentation verification against case report form data, • Informing site staff of any entry errors. • Ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements. • Provide high-quality data by keeping the number of errors and missing data as low as possible and gather maximum data for analysis • Supervise the application of quality control procedures along with responsibility for database locks. • Accuracy verification of generated data reports. • Identify problems and trends retrospectively via sampling of subjects and data • Compile all data components to gain a measurement of compliance. • Summarize quality assurance (QA) findings and report to upper management. • Develop necessary quality improvement (QI) plans. • Generation of queries per EDC guidelines of clinical trial, closing resolved queries and re-issuing queries when necessary. • Coordinate clinical trial activities. • Performed revision of Data Entry Guidelines for clinical trial study. • Performed data field edit checks. • Participated in work streams and process improvement initiatives. • Served as a Power User for EDC of a clinical trial study and an Administrator for Clinical Trial Study Imaging Database. • Imaging Database Management of incoming clinical site data, maintenance of database ensuring integrity of the database. • Collaborated with other clinical research team members and project managers to ensure that trials are conducted and maintained in a standardized way. • Other duties as assigned. Show less



Brighter Horizons Academy

• United States
• 1 - 100 Employee

• Teacher (General Science for grades 6th, 7th, 8th and Biology & Chemistry for grades 9th &10th)

  • Sep 2012 - May 2016

  Amman, Jordan • Prepare lesson outlines, lesson materials, bulletin board displays, exhibits, equipment, and demonstrations, exams and plans in assigned subject areas that create an environment where children are actively engaged in the learning experience. • Provide constructive feedback for enhancement in which children are encouraged to be engaged in the learning process. • Identify and adapt teaching resources in order to meet the varying needs of children with different … Show more • Prepare lesson outlines, lesson materials, bulletin board displays, exhibits, equipment, and demonstrations, exams and plans in assigned subject areas that create an environment where children are actively engaged in the learning experience. • Provide constructive feedback for enhancement in which children are encouraged to be engaged in the learning process. • Identify and adapt teaching resources in order to meet the varying needs of children with different learning abilities, and special education needs. • Maintain an accurate teaching record and monitor learning performance to provide feedback on progress and foster student success – Prepare and evaluate students’ performance to monitor progress. • Research and utilize variety of learning materials, resources and technology methods [such as: Internet- based learning, library, team learning] to support and develop the classroom environment. • Advise and monitor children in the use of new learning materials and teaching equipment. • Communicate cooperatively with peers, colleagues and parents to meet teaching goals and ethical standards. • Participate in training programs and educational courses to keep up to date with new teaching methods, new developments and teaching resources. • Apply appropriate disciplinary measures when necessary. Show less



UMass Lowell

• United States

• Teaching Assistant

  • Sep 2007 - Jan 2009

  Performed research project studying amylotropic lateral sclerosis (ALS), another type of neurodegenerative disease and the role of neuro-filaments in this disease. (Ongoing project); Prepared lesson outlines, lesson materials, bulletin board displays, exhibits, equipment, and demonstrations, exams and plans in assigned subject areas. Grading research assignment and tests

• Research Associate

  • Sep 2006 - Jan 2009

  • Studied Alzheimer’s disease and the effects of folate and S-adenosyl menthionine (SAM) on the formation of paired helical filaments (PHF), a classic hallmark of Alzheimer's disease. [The study examined such relationships using the antibody PHF-1 which tags to abnormally phosphorylated tau protein. The study showed that low levels of folate resulted in high fluorescence displayed in differentiated SHSY-5Y human neuroblastoma cells. Increased fluorescence indicates high levels of… Show more • Studied Alzheimer’s disease and the effects of folate and S-adenosyl menthionine (SAM) on the formation of paired helical filaments (PHF), a classic hallmark of Alzheimer's disease. [The study examined such relationships using the antibody PHF-1 which tags to abnormally phosphorylated tau protein. The study showed that low levels of folate resulted in high fluorescence displayed in differentiated SHSY-5Y human neuroblastoma cells. Increased fluorescence indicates high levels of phosphorylated tau protein that causes brain degeneration. However, cells in folate/S-adenosylmethionine+ showed low levels of fluorescence indicative of low phosphorylated tau protein suggesting protection against brain damage]. • Performed research project studying amylotropic lateral sclerosis (ALS), another type of neurodegenerative disease and the role of neuro-filaments in this disease. (Ongoing project)



Pentucket Medical Associates

• United States
• Hospitals and Health Care
• 100 - 200 Employee

• Medical Assistant/Phlebotomist/EKG Technician

  • May 2005 - Jul 2005

  [Internship] - Prepared and assisted patients before check-up with the doctor, drawing blood, and medical filing