Jennifer Cotreau
Billerica,MA
Summary
Clinical research professional with strong focus on managing clinical trials and ensuring regulatory compliance. Skilled in project management, data analysis, and stakeholder engagement. Known for fostering team collaboration, adapting to changing needs, and delivering reliable results. Adept at navigating complex protocols and driving clinical studies to successful completion.
Experienced with overseeing clinical trials to ensure adherence to regulatory guidelines and protocols. Utilizes strong project management skills to streamline trial processes and enhance operational efficiency. Track record of effectively managing cross-functional teams and mitigating risks in clinical research.
Results-oriented achiever with proven ability to exceed targets and drive success in fast-paced environments. Combines strategic thinking with hands-on experience to deliver impactful solutions and enhance organizational performance.
Thorough team contributor with strong organizational capabilities. Experienced in handling numerous projects at once while ensuring accuracy. Effective at prioritizing tasks and meeting deadlines.
Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Sr. Clinical Trial Manager - Consultant
Q32 Bio, Inc.
07.2024 - 11.2024
- Serves as the primary study lead for a Phase II OUS Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis renal MAD clinical study, consulting with Actalent Scientific, LLC, Woburn, MD.
- Leads and manages clinical MAD study to ensure studies are conducted in accordance with approved scope of work/budget, and regulatory guidelines in US and OUS, and operate within established timelines.
- Facilitate negotiations and preparation of vendor start-up contracts, SOWs, related documents and reviews contracts for completeness and accuracy.
- Oversees the financial aspects of analyzing quotes/proposals in collaboration with procurement to managing vendor budgets and ensuring accurate invoice reconciliation.
Serves as primary lead for vendor contracts for both internal and external stakeholders and provided functional guidance to keep the teams aware of all contract statuses and/or pending issues. - Responsible for managing 20 vendor study budgets and reviewing forecasts, accruals and actual spending. Manages outsourced clinical operations vendors which include full service CRO, central lab, data management, biostats, EDC, IRT/RTMS, biomarker lab, kidney biopsy labs, and PK labs.
- Conduct weekly clinical team meetings with internal and external stakeholders from site feasibility, study start-up, site activation and provide study updates accurately regularly through frequent communication with stakeholders to meet study milestone deliverables. Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc.
- Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
- Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
- Oversee and manage the site feasibility activities with outsourced CRO, site selection, site activation to ensure timely attainment of study trial milestones without delays.
- Proactively identifies study issues and develops problem-solving strategies to ensure delivery of quality data.
- Manages the initial set-up of Veeva eTMF license, new study set-up of TMF Plan, eTMF Index to ensure the eTMF is maintained, up to date, and audit ready for regulatory inspections.
- Complies with ICH GCP guidelines, FDA regulations, sponsor SOPs, and is responsible for vendor SOP mapping.
- Streamlined trial management processes for increased efficiency through diligent organization and coordination of resources.
- Collaborated closely with biostatisticians for accurate statistical analysis planning in support of study objectives.
- Mitigated risks in the clinical trial process by proactively identifying potential issues and implementing corrective actions.
- Prepared detailed progress reports for sponsors and stakeholders, keeping them apprised of key developments in ongoing trials.
Global Trial Leader - Consultant
Johnson and Johnson
01.2024 - 05.2024
- Lead the cross-functional trial team as an Interventional Oncology consultant tracking and managing project deliverables, milestones, and timelines during vendor start-up activities for a Phase I OUS Immuno-Oncology randomized, double blinded study, consulting with Eight Eleven Group, LLC, DBA Medasource, Indianapolis, IN.
- Accountable for oversight of all external service providers used for the trial for in-house study during start-up.
- Facilitate negotiations and preparation of vendor contracts, and related documents and reviewed contracts for completeness and accuracy.
- Oversaw the financial aspects of analyzing quotes/proposals in collaboration with procurement to managing vendor budgets and ensuring accurate invoice reconciliation.
- Ensured trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.
- Served as primary lead for vendor contracts and internal and external stakeholders and provided functional guidance to keep internal and external teams aware of all contract statuses and/or pending issues.
- Identified vendor risks and ensure mitigation and contingencies are being initiated and followed through (including management of CAPAs).
- Cross-functionally interact with the Therapeutic Area, Clinical Supply Chain, Quality and Compliance Group, Clinical Business Operations, Finance, Project Management, and external partners to influence alignment on issues and decisions affecting trial management, enabling successful trial outcomes.
- Ensure regional/global clinical operations deliverables progress according to agreed-upon timelines and milestones as leader of the Study Management team.
- Accountable for delivery of global trials within agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of assigned trials for both Out of Pocket (OOP) costs and FTE costs.
- Ensure that protocol feasibility and country and site selection processes are conducted within timelines.
- Created and develop study-specific documents such as Monitoring Guidelines, Informed Consent
Form, IMP related documentation, Blinding Plan, country, and site feasibility related documents,
Safety related documents, Protocol Deviations and Issue Escalation processes. - Ensured trial related issues (quality, timelines, budget, resources) are managed timely, accurately and escalated and reported to relevant key stakeholders.
- Developed Provider Oversight Plan, Filing Plan and Archiving Plan for essential documents into internal Veeva Vault (eTMF).
- Ensured Trial Team members have received the appropriate trial-specific training needed for their function.
- Identified team weak points and implemented corrective actions to resolve concerns.
- Led cross-functional teams to achieve company-wide goals, fostering a culture of collaboration and innovation.
- Overcame challenging deadlines and resource limitations by reallocating personnel and focusing on priority tasks.
- Managed budgets and resources, ensuring optimal allocation towards achieving organizational objectives.
- Created and managed project plans, timelines and budgets.
Sr. Clinical Trial Manager - Consultant
Pulmatrix, Inc.
08.2023 - 10.2023
- Managed the study close-out activities of Phase 2 OUS, randomized, double blinded, 16-week placebo controlled, drug device combination study, outsourced CRO model, consulting with Conjugate Group, Waltham, MA.
- Participated in selection of travel reimbursement vendor services to help increase enrollment prior to study close-out in January.
- Oversaw and managed study vendors relationships, and external partnership initiatives with, central labs, specialty testing labs, biomarkers testing lab, and diagnostic testing ECG/PFT Imaging labs reconciliation of EDC.
- Assisted the team with the management of clinical supplies and equipment distribution receipt and return with all clinical sites, including coordination and trouble shooting. Provided clinical operations support for vendors across multiple study protocols.
- Mitigated risks in the clinical trial process by proactively identifying potential issues and implementing corrective actions.
- Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
- Evaluated study metrics and key performance indicators to ensure study vendor oversight of clinical trial progress and performance.
- Assisted with financial management of vendors, including invoice reconciliation, budgets, monthly/quarterly accruals, and variance reports for vendor contracts to senior management.
- Assisted in the development of study close-out process for audit readiness with vendors and sites.
- Participated in weekly CRO vendor meetings and specialty lab vendor meetings to manage timelines and deliverables.
- Reviewed and audited essential study documents, monitoring reports, study plans, SOP’s, lab manuals, and trackers.
- Worked directly with investigational sites to ensure vendor issues were escalated and addressed thoroughly and quickly.
- Monitored the performance of vendors to evaluate and mitigate program compliance risk(s), and escalated quality issues ensuring quality standards were followed per ICH-GCP and FDA guidelines.
- Ensured the company had risk-based quality process in place for vendor management oversite to address quality issues as needed.
- Conducted external CRO vender audit of study eTMF, performed quality review of essential study documents in eTMF, and prepared gap analysis, CAPA to ensure audit readiness for study close-out initiative and audit readines
Sr. Clinical Trial Manager - Consultant
Acadia Pharmaceutical, Inc.,
02.2023 - 07.2023
- Lead clinical study teams and represent clinical operations on multi-function project teams internally and externally.
- Managed the start-up activities of Phase III OUS, multi-center, randomized, double-blind, 8-week placebo-controlled, drug device combination study outsourced CRO model, consulting with KPS Life, Inc., Malvern, PA.
- Facilitated and drove the planning of scientific advisory board meetings with caregivers, advocacy groups, and symposia conferences focusing on Prader-Willi Syndrome.
- Assisted in the design and review of clinical protocols, informed consent documents, feasibility questionnaires, IRT,
eConsent, and eCOA clinical trial technology trials set-up. - Oversaw external vendors management of contract research organizations (CROs) and Clinical Research Associates/Assistants.
- Prepared detailed progress reports for sponsors and stakeholders, keeping them apprised of key developments in ongoing trials.
- Facilitated clear communication between study teams, sponsors, and investigators to maintain alignment on project goals and expectations.
- Ensured compliance with regulatory guidelines by thoroughly reviewing protocols, informed consent forms, and other essential documents.
- Implemented risk management strategies, effectively minimizing potential threats to the success of clinical trials.
- Contributed to protocol development, ensuring a well-designed study that met research objectives while adhering to ethical standards and regulations.
- Prepared and reviewed (if CRO engaged) all applicable essential study documents required for the conduct of the study, Project Plan, Risk Management Plan, Protocol Deviation Management Plan, Monitoring Plan, TMF Plan, etc.
- Drove study start-up initiatives and timelines for vendor set-up, study set-up meeting enrollment milestones.
- Liaises with other functional groups to ensure that timelines, budgets and study objectives are met on time and on budget.
- Provided clinical trial status updates to project teams and senior management during program and study team meetings internally.
- Managed the vendor study budgets and contracting process with the legal and procurement team to ensure all vendor contracts, WOs, POs were executed and paid on time.
- Presented status updates at internal and external study vendor meetings, created internal milestone tracking tools to update senior management on study start-up initiatives.
- Supervised and trained junior staff on study specific activities and responsibilities to help support milestones delivery on time.
Sr. Clinical Project Manager
Capricor Therapeutics, Inc.
06.2022 - 11.2022
- Managed the study conduct of a Phase 3 US randomized, double blinded placebo controlled, pediatric trial and provided operational leadership within an outsourced CRO model.
- Responsible for the project management oversight of study timelines, budget, risk, and contingency planning ensuring quality standards are followed per ICH-GCP and FDA guidelines.
- Evaluated performance metrics against established benchmarks, identifying opportunities for improvement and implementing appropriate action plans.
- Optimized and created study processing tools for metric and systems tracking to enable effective, efficient, and compliant team performance to meet corporate deliverables and investigator milestones.
- Assisted in the feasibility assessment and site selection of investigator sites and outsourced vendors to ensure they were qualified.
- Performed vendor study gap analysis to address study program gaps and risks for transfer of obligations to CRO vendor. Created story boards from gaps identified to prepare for FDA inspection readiness and developed SOPs and mitigation risk plans to trackers vendor deviations and CAPAs.
- Facilitated and led strategic program decisions to optimize management of scope, financials and identified risks and/or impacts that would affect project execution timeline and deliverables of vendor management oversight budget milestones payments.
- Coordinated CRO vendor kick-off meetings, study investigator’s meetings, monthly investigator team meetings.
- Assisted with the site selection process and qualification of investigator sites, ensuring regulatory compliance is complete in accordance with, ICH-GCP prior to activating site in study.
- Managed clinical trial budgets, providing ongoing financial reporting and projections to finance, and reviewed and tracked the status of projects and deliverables.
- Participated in safety committee DSMB meetings and tracked protocol study deviations.
- Authored and reviewed study documents such as study protocols, informed consent templates, monitoring plans,
DSMB/CEC/Steering committee charters, Investigator’s Brochures, and Clinical Study Reports, etc. - Lead cross-functional project meetings internally and externally for site and vendor management oversight to meet study milestones and deliverables.
- Supervised, trained junior staff on study specific activities and responsibilities to help support milestones delivery on time.
- Evaluated performance metrics against established benchmarks, identifying opportunities for improvement and implementing appropriate action plans.
- Mentored junior staff members in clinical project management best practices, fostering a culture of continuous learning and professional development.
Sr. Clinical Trial Manager - Consultant
Stemline Therapeutics, Inc.
10.2021 - 04.2022
- Managed the conduct of clinical trial(s) and provide operational leadership within an outsourced, CRO model for a first in man, phase I, US oncology clinical trial, consulting with Green Key Resource, New York, NY.
- Collaborated with other departments to meet study timelines and goals.
Lead close-out planning, communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
Directed start-up and close-out activities, deliverables, milestones prior to final database lock and site closure audit readiness.
Ensures that all activities related to the clinical trial close-out are performed appropriately, documented, reconciled, recorded, and is audit ready in accordance too the protocol, relevant SOP’s and GCP guidelines. - Primary point of contact for external vendors and partners.
- Managed study-specific vendors, as appropriate. Serves as the primary project contact for communication and coordination for sponsors, third-party vendor(s), and project needs.
- Interacts often with external partners, including, expert panels, investigators, CROs, contract laboratories, advisory committees, clinical trial consultants, and cross-functional counterparts to meet study milestones.Leads study management team meetings and teleconferences for internal and external stakeholders, study team meetings, investigator meetings, CRA meetings, vendor meetings and trainings.
- Responsible for monitoring clinical study budgets and monthly review of budget invoices with CROs, vendors and investigator sites in collaboration with the finance team.
- Provides input into vendor contracts, work orders and/or change orders with the finance team.
- Ensures appropriate oversight of Contract Research Organizations (CROs), clinical trial sites and other external vendors, including assessment of performance against contractual obligations.
- Builds solid relationships with key counterparts at CRO(s) and other external vendors.
- Communicates with clinical trial sites as appropriate to ensure optimal Sponsor-Site relationships.
- Ensure that the electronic Trial Master File (eTMF) is maintained appropriately throughout the trial, including periodic reviews.
Sr. Clinical Trial Manager - Consutant
Point Biopharma, Inc.
06.2021 - 09.2021
- Manage the conduct of Phase II-III clinical trial(s) and provide operational leadership within an outsourced, CRO model.
- Assist in the review, development and/or writing of clinical trial documents and manuals, including but not limited to Protocol, Case Report Forms, Informed Consent Forms and other regulatory documents.
- Manage the evaluation and selection of investigative sites.
- Select, coordinate and monitor the activities of CRO and associated vendors.
- Develop and manage trial timelines, budget and project milestones.
- Participate in data management activities, where indicated to ensure the highest data quality.
- Ensure set up, and maintenance of systems to track progress throughout the duration of the program.
- Generate necessary reports to update leadership on trial conduct and progress.
- Develop recruitment plans, risk mitigations plan, monitor and implement contingencies as required.
- Develop key study quality metrics and determine appropriate action in conjunction with the study team.
- Perform review of CRO and other third-party study vendor invoices, ensure work is performed in accordance with scope of work.
- Lead the multi-disciplinary teams in operational study team meetings.
- Function as primary contact for trial(s) between Clinical Development and other departments.
- Delivery of Trial(s) on time, within budget and with highest achievable quality.
- Collaborate with CRO to ensure patient enrollment and data collection are completed in accordance with study timelines
and objectives; escalate risk to timelines and budgets as needed. - Review Study Protocols, eCRF design and completion guidelines, study manuals, ICFs and other study related materials.
- Assist with cross functional training on protocols and practices.
- Collaborate with CMC group to ensure appropriate tracking, delivery of IP products and trial supplies.
- Perform review and QC of trial master file, ensuring overall inspection readiness.
- Participate in the development, review and implementation of departmental processes and SOP
Sr. Clinical Operation Trial Lead - Consutant
Corium Inc.
01.2021 - 03.2021
- Provide leadership, therapeutic expertise, and oversight for the successful management of clinical studies for both domestic and international clinical trials (Phase I - IV) across indications, consulting with Ortek Group Inc., Clifton, NJ
- Provided professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations for FDA inspections and other regulatory agency inspections.
- Escalated systemic and/or critical problems and recommended appropriate solutions to senior management for immediate and long-term resolution. for non-compliance regulatory issues and processes.
- Participate in investigations into significant quality issues, scientific misconduct and serious breach of GCP; facilitate
identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities. - Supported development of SOPs, participated in annual updates of collaborative SOPs and training.
- Collaborated cross-functionally on due-diligence efforts and assessments for mergers and acquisitions.
- Managed the move and audit of paper study essential documents into a new electronic trail master file (eTMF) SharePoint and developed a standard eTMF filing index and SOP for studies for audit readiness.
- Initiates and oversaw continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams.
- Participate in due diligence activities and process improvement initiatives as requested by management.
- Liaise with various Sponsor functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance.
- Collaborate with Quality Compliance and Systems team and Learning Management Team to identify and mitigate GCP quality and compliance issues with potential impact across multiple programs and or functional groups.
- Independently manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP and Sponsor policies and procedures; assess impact of audit findings on subject safety, data integrity, and operations contingency planning ensuring quality standards are followed per ICH-GCP and FDA guidelines.
- Implement program-specific risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors, and internal systems in compliance with GCP and company policies and procedures.
- Provide expertise in GCP compliance interpretation, consultation, training, recommendations to clinical operations teams.
Sr. Clinical Scientist Project Manager,
Merck & Co., Inc.
12.2015 - 07.2020
- Accountable for the successful leadership, comprehensive clinical and operational planning/feasibility execution of Immuno- Oncology and Hematology trials (First in Human/Phase I - II) within external collaboration group at Merck & Co., Inc., consulting with Parexel, DBA ExecuPharm, Inc., King of Prussia, PA.
- Primary point of contact for all eleven external partner collaboration clinical studies.
- Provides operational management, therapeutic knowledge, and oversight for the successful management of both US and OUS clinical trials (First in Human/Phase I - II) across multiple indications through internal and external clinical study teams.
- Responsible for trial design and endpoint development with external partners in collaboration with the Clinical Director.
Responsible for timeline management and conducts project risk analysis and develops risk mitigation strategies for a variety of complex problems to maintain study deliverables on time and on budget. - Contributed to the development and continuous improvement of standard operating procedures, ensuring best practices within clinical research efforts.
- Conducts oversight and preparation of clinical study documents and reviews for inspection readiness activities.
- Managed clinical trial budgets, providing ongoing financial reporting and projections to finance group.
- Ensured clinical trials are executed per key KPIs, KQIs metrics were met, and timelines, budgets, were operational and met quality standards per ICH-GCP regulatory standards.
- Facilitated and collaborated with key internal and external stakeholders (trial team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives. Leads and directs team in key study planning, development and execution elements (e.g., data management deliverables, protocol level plans/timelines, country/site selection, system updates, Investigator Meeting planning and presentations, communication plans, safety and medical monitoring, preparation of status update reports and study closeout activities.
- Responsible for authoring clinical protocols, clinical study reports, regulatory agency update reports, responses to regulatory agencies, and other clinical and regulatory documents.
- Collaborated with cross-functional teams to ensure timely completion of project milestones.
- Collaboratively plans Clinical Study Reports with partners and reconciles and reviews all protocol deviation list for CSR.
- Clinical point of contact for scientific issues and questions for internal and external stakeholders, IRB’s and partners.
- Collaborated cross functionally with Medical Affairs, Regulatory Affairs, Commercial, Pharmacovigilance, Alliance Management, Business Development, Drug Supply etc., in the support of products throughout their lifecycle.
- Responsible for management of trial level communications and activities to ensure that the Trial Master File is completed in accordance with ICH-GCP and per Merck SOP’s.
- Supported Clinical Directors in scientific leadership investigator initiatives including preparation of publications, meeting presentations and co-authoring newsletters.
- Accountable for managing any trial specific partners and/or vendors, coordinated planning of central biomarker PD-L1 lab set-up, bio specimens and imaging specification and participants in database lock activities.
Project Manager - Consultant
Biogen Inc.
10.2014 - 12.2015
- Responsible for supporting the global medical external partnership team in the planning, execution of strategic stakeholder engagement tracking progress of key deliverables for Alzheimer’s and Multiple Sclerosis program from Phase II-III, within clinical operations, consulting with Logix Inc., Waltham, MA.
- Leads and facilitates the external stakeholder identification process to key business functional areas.
- Facilitates and drives the planning of scientific advisory board meetings, symposia conferences across multiple pipelines.
- Conducts site selection identification mapping for multiple phase studies and therapeutic areas.
- Tracks multiple pipeline status and their progress of open action items and pending issues by documenting the progress of deliverables that require ongoing communication with each global functional representative.
- Identifies program risks assessments contingency planning for global functional representatives, escalate risks, propose solutions.
- Conducts external stakeholder planning and identification training, workshops to key business functions areas.
- Works closely with regional and local affiliates to ensure the team is provided with necessary support for stakeholder planning.
- Oversees and manages key vendors’ relationships with the daily operation and execution of all external partnership initiatives.
- Manages required budget deliverables with the finance department including purchase orders, monthly forecasting, and approval of site and vendor payments and liaise with legal department to drive contract negotiations in timely fashion.
- Works closely with global cross functional teams to identify key topics for the team to address and review in support of franchise external engagement plans.
- Accountable for the development and management of all project management tools to ensure tactics are documented, tracked, and completed according to the study plan.
- Manages the program team’s specific requests for thought leader data and analytics through varies technology platforms such as Team Net, Share Net, dashboards to ensure ease of use and alignment with other technology platforms.
- Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
- Coordinated with cross-functional teams to resolve project issues and mitigate risks.
Sr. Project Management Associate
Sarepta Therapeutics, Inc.
12.2011 - 09.2014
- Managed and drove the planning of study programs timelines to ensure both internal and external milestones were met for multiple Phase I-II Duchene Muscular Dystrophy, rare disease global clinical trials were executed on time.
- Responsible for execution of study start-up, study closeout for study programs within budget and resolving issues as they arise.
- Developed study start-up and close out plan for multiple programs; reviewed KQI’s and tracked KPIs on those projects ensuring both milestone and deliverables were not at risk.
- Developed detailed project plans to guide teams towards successful completion of objectives within defined constraints.
- Worked closely with the cross functional team to determine necessary resources planning to effectively launch study in one or more pediatric study programs, on time and on budget.
- Responsible for site selection identification and mapping for phase I-II study sites.
- Designed study program budget forecast to track the deliverables and scope of work.
- Managed required deliverables with the finance department including purchase orders, monthly forecasting, site budget approval, vendor payments; liaised with legal and finance department to drive contract negotiations forward in a timely fashion.
- Prepared study program budgets for board of directors and stakeholders as needed.
- Served as a key point person with all internal and external vendors and negotiated MSAs, CTAs, SOWs, POs, WOs with outsourced vendors, Central Lab, Imaging Lab, CRO vendor, contracted consultants, and government grants.
- Oversaw all study oversight activities at with CROs; attended co-monitoring visits as needed with contract CRAs during SIVs.
- Fostered relationships with external vendors, negotiating contracts that resulted in cost savings without sacrificing quality.
- Performs remote monitoring, reviewed EDC data entries and monitoring reports submitted by outsourced CRAs.
- Maintained internal clinical tracking systems and tools to support the conduct of the clinical program from start-up to close-out.
- Managed and oversaw CRA monitors, vendor to ensure patient enrollment activities and data collection activities were completed in accordance with study milestones.
Education
Bachelor of Science - Speech
Emerson College
Boston, MA05-2003
No Degree - Pursued, Bachelor of Science in Nutrition And Diet
Saint Joseph College
West Hartford, CTAssociate of Science - Liberal Arts And Sciences
Middlesex Community College
Bedford, MA05-1995
Skills
- Project & Program Milestone Management
- Cross-Functional Collaboration Communication
- Timeline Management
- Data Management
- Clinical Trial Oversight
- Vendor Management
- Budget Negotiation Skills
- Drug Distribution Strategy
- Site Evaluation and Start-Up Management
- Audit Preparation
- Trial Master File Management
- Stakeholder Collaboration
- GCP, GMP-QA, FDA-CFR 21, ICH-E6 R2 Compliance
- Safety Letter Reporting
- CIOMS/SUSAR Submissions
- Regulatory Strategy
- Global Scientific Advisor Board Planning
- INDs/NDAs, CTAs, Submissions
- Risk Management
- Site Engagement Strategy
Certification
Barnett International Feb 2005
Certificate CRA & CRC Beginner 10-Week Program
Clinical Trial Systems
- Spectrum (eTMF)
- Veeva Vault (eTMF)
- Oracle (eTMF)
- Medidata Rave (eTMF)
- Suvoda (IRT)
- Inform (EDC)
- ARIES/MARRS
- Medidata Rave (EDC)
- Oracle (EDC)
- Signiant Health (Scales)
- RCAM (access to protocols, CSRs, etc.)
- Medidata Rave Clinical Cloud (eTMF)
- IVRS (aka IRT, patient allocation)
- Medrio (RTMS/EDC)
THERAPEUTIC EXPERIENCE
- Cardiology Disease
- CNS Disease
- Infectious Disease
- Metabolic Disease
- Neurological Disorder
- Rare Disease
- Oncology Disease
- Ophthalmology Disease
- Pulmonary Disease
Timeline
Sr. Clinical Trial Manager - Consultant
Q32 Bio, Inc.
07.2024 - 11.2024
Global Trial Leader - Consultant
Johnson and Johnson
01.2024 - 05.2024
Sr. Clinical Trial Manager - Consultant
Pulmatrix, Inc.
08.2023 - 10.2023
Sr. Clinical Trial Manager - Consultant
Acadia Pharmaceutical, Inc.,
02.2023 - 07.2023
Sr. Clinical Project Manager
Capricor Therapeutics, Inc.
06.2022 - 11.2022
Sr. Clinical Trial Manager - Consultant
Stemline Therapeutics, Inc.
10.2021 - 04.2022
Sr. Clinical Trial Manager - Consutant
Point Biopharma, Inc.
06.2021 - 09.2021
Sr. Clinical Operation Trial Lead - Consutant
Corium Inc.
01.2021 - 03.2021
Sr. Clinical Scientist Project Manager,
Merck & Co., Inc.
12.2015 - 07.2020
Project Manager - Consultant
Biogen Inc.
10.2014 - 12.2015
Sr. Project Management Associate
Sarepta Therapeutics, Inc.
12.2011 - 09.2014
Bachelor of Science - Speech
Emerson College
No Degree - Pursued, Bachelor of Science in Nutrition And Diet
Saint Joseph College
Associate of Science - Liberal Arts And Sciences
Middlesex Community College
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