Experience

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  Montreal university health centre (mcgill- royal victoria hospital)

  Dec 2003 - Dec 2004

  Project manager

  Quebec IBD Genetic Consortium (QIGC) - NIH sponsored- Co-ordinate communication between 11 hospitals participating in the study- Submit amendments to the Ethics Committee - Monitor the Centres to ensure quality and integrity - Database management- Follow-up expenses & budget- Patient recruitment at the Royal Victoria Hospital

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  Astrazeneca

  Dec 2004 - Nov 2007

  Clinical site monitor

  Managed 8 projects and 12 sites in Oncology, GI, Neurology and Cardiology

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  Lundbeck canada inc.

  Nov 2007 - Oct 2008

  Cra

  Managed 4-5 projects and 8-10 sites in Psychiatry

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  Icon clinical research

  Oct 2008 - Jul 2010

  Senior clinical research associate

  FSP-Contracted Partner of AmgenManaged 10 projects and 16 sites in Oncology- Follow-up on Ethics submissions for the assigned study sites and perform quality control - Regulatory document collection, tracking, and maintenance of Sponsor File- Verification of ICFs - Attend Investigator’s Meeting - Perform visits to assigned sites and complete monitoring reports, follow-up letters, etc.- Maintain close contact with sites regarding recruitment and compliance with the study protocol and applicable regulations/guidelines- Provide ongoing site training and site support, including eCRF training, maintain outstanding professional relationships with investigators and their staff to foster a positive corporate image Show less

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  Endoceutics

  Aug 2010 - Dec 2010

  Clinical quality assurance director

  Quality Assurance of Phase III trials & clinical research advisor.- Prepare, revise and maintain relevant Master Clinical compliance audit plans- Plan, manage and lead the conduct of domestic and international audits- Manage QA’s internal audits as per Endoceutics’ SOPs- Prepare audit reports and follow-up with corrective and preventative action plans- Develop, manage and maintain QA audit database- Perform quality review of draft documents (e.g. Protocols, ICFs, IBs) to assure accuracy, completeness, consistency and compliance with regulatory requirements- Assist in the development, implementation, and maintenance of QA SOPs- Assist in the development and implementation of GCP training programs for external study personnel (e.g. CRAs) Show less

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  Trio

  Jul 2011 - Nov 2012

  Monitoring resources coordinator-rest of the world

  Key responsibilities:- Oversight 18 Rest of the World (ROW) Clinical Research Associates (CRAs) working on 5 Clinical Studies in Oncology (Breast & Ovarian Cancer)- Communicate regularly project status for 6 countries assigned (Brasil, Peru, South Africa, Lebanon, Egypt & Spain)- CRA training: study specific issues, SOPs and GCPs- Assessment visits & Audit reports follow-up- Selection and CRAs sites’ assignments - Follow-up CRAs on productivity and metrics to meet project deliverables- Participate in TRIO SOPs working groups Show less

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  Quintiles

  Nov 2012 - Apr 2013

  Senior clinical project manager

  Managed Investigator's Initiated Studies (IIS) in USA and Canada for Janssen, Pharmaceutical Companies of Johnson & Johnson.

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  Pra international

  Aug 2013 - Aug 2015

  Sr clinical research associate
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  University health network- princess margaret hospital

  Aug 2015 - Aug 2016

  Clinical research program manager- radiation medicine

  • Managing a team of 22 Clinical Research Professionals (Clinical Research Coordinators, Data Managers, Regulatory Affairs Coordinator & Research Analysts) as direct reports• Responsible and accountable for the progress of all the clinical trials conducted at the Radiation Medicine Program (+50 ongoing)• Ensured compliance to study specific requirements, adherence to regulatory guidelines and local requirements, respecting timelines, projected milestones and the budget for each study• Responsible for introducing new procedures for a more effective and efficient work flow of operations• Responsible for people development and engagement• Responsible the performance evaluation during and at the end of the year• Awarded "Exceptional Research Support for 2015/2-016" & "Chief Choice Presentation 2015/2-016" Show less

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  Pra health sciences

  Aug 2016 - Jun 2017

  Sr. cra
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  Merck

  Jul 2017 - Apr 2021

  Clinical research manager

  - Accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck policies and procedures, quality standards and adverse event reporting requirements internally and externally. - POC for assigned protocols between Global and Country Clinical Operations (CO)- Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments for assigned protocols. - Strong collaboration with local CO roles- Forecasts country resource needs- Responsible for quality and compliance in assigned protocols in country- Oversees CRAs, COMs and CTCs- Oversees training compliance- Performs quality control visits- Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed- Responsible for collaboration with functional outsourcing vendors, investigators, other external partners- Oversees country and site validations, site selection and recruitment in assigned protocols- Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD and Regional Operations Show less

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  Pra health sciences

  May 2021 - Dec 2022

  Operational study manager- real world solutions

  Operational Study Manager in Real World research with emphasis on post-marketing research and qualified minimal risk studies. Experience in late phase study designs including disease and product registries, observational studies, non-interventional studies, safety and risk management studies, Drug Utilization, biomarker studies, and prospective and retrospective studies. Responsibilities include oversight of operational team and management of study sites from recruitment through study closure.• Oversee the delivery of Site Management project tasks, providing advice and guidance to achieve high performance and quality project deliverables.• Ensure overall project efficiency and adherence to project timelines and financial goals; report metrics and out of scope activities.• Develop, implement and maintain the Site Management Plan within the agreed project strategy.• Collaborate with other functional groups within the company such as data management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.Current Projects:- Extension study: 70 sites and 1000 patients in USA in Fat Liver Disease- Historical and Retrospective Chart Review: 10 sites (in USA) in HDFN (pregnancies with early onset severe)- Extension study: 3 sites in USA & Canada in Prostate Cancer Show less

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  Alexion pharmaceuticals, inc.

  Jan 2023 - now

  Global study lead (slco)

  • Primary point of contact for the Country Operations Management (COM) team at the global study level, partnering closely with the Clinical Project Lead (CPL) and other global functional stakeholders as required. • Work with global and country teams to determine appropriate country footprint for the study, including consolidation of information from country teams to support internal governance approvals for the study• Lead Key External Expert (KEE) outreach activities, working with Alexion Global Feasibility & Site Intelligence (GFSI), and across COM to assess study design suitability or identify opportunities for protocol improvement• Work with GFSI on detailed site feasibility and coordinate with country teams to arrive at proposed final breakdown of countries/sites/patients for endorsement by Global Program Team (GPT)• Coordinate and maintain global oversight of country and site start-up (SSU) activities performed by country teams and/or CRO partner• Contribute to patient recruitment, retention and engagement strategy development and execution (inclusive of patient insight activity)• Maintain global oversight of study deliverables, milestones and site monitoring (e.g. country/site selections, start-up activities, enrolment, data metrics, close-out activities, etc.) throughout the study lifecycle • Ensure a state of ‘Inspection Readiness’ • Work with global and country-level stakeholders to mitigate risks or issues related to site management and monitoring as they arise Show less