Experience

Alimentiv

• Canada
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Senior Director Clinical Operations

  • May 2018 - Present

  Responsible for providing leadership, oversight, planning, and execution of strategy for the Monitoring and Site Management (MSM), the Trial Master File operations (TMFO), Logistics, Operational Analytics and Risk Management (RBQM) departments at Alimentiv. As part of the senior leadership team, participate in the development and implementation of organizational strategies, technologies and best practices that ensure superior customer service, staff development, quality information management… Show more Responsible for providing leadership, oversight, planning, and execution of strategy for the Monitoring and Site Management (MSM), the Trial Master File operations (TMFO), Logistics, Operational Analytics and Risk Management (RBQM) departments at Alimentiv. As part of the senior leadership team, participate in the development and implementation of organizational strategies, technologies and best practices that ensure superior customer service, staff development, quality information management reporting and effective, efficient divisional short and long-term goals that align with the organization's vision, mission, and direction. Role includes policy and process development and improvement, product quality, compliance monitoring, staff resource planning, staff and contractor performance management, providing support, expertise, and represent project and unit teams with sponsors/clients throughout the project life cycle. Ensure all team members deliver high quality, timely service and that service delivery processes are maintained in accordance with corporate and industry best practices that meet all regulatory requirements and guidelines.

• Director, Monitoring & Site Mangement

  • Aug 2017 - Present

  Toronto, Canada Area Responsible for providing leadership and oversight to support the Global Monitoring and Site group; As part of the senior leadership team, participate in the development and implementation of organizational strategies, technologies and best practices that ensure superior customer service, staff development, quality information management reporting and effective, efficient divisional short and long term goals that align with the organization's vision, mission, and direction.



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Manager, GCO Pfizer Process Lead

  • 2016 - Aug 2017

  Toronto, Canada Area - Oversee all Global Clinical Operations (GCO) process related requirements for the Client partnership - Coordinate and lead GCO Business Process Owners - Ensure harmonized roll out and ongoing implementation of process and related communications; outlining scope, impact and timelines for all process affecting GCO - Coordinate and lead analysis into performance and compliance of process amongst GCO, implement Root Cause Analyses and process improvements to maintain ‘green’ metric… Show more - Oversee all Global Clinical Operations (GCO) process related requirements for the Client partnership - Coordinate and lead GCO Business Process Owners - Ensure harmonized roll out and ongoing implementation of process and related communications; outlining scope, impact and timelines for all process affecting GCO - Coordinate and lead analysis into performance and compliance of process amongst GCO, implement Root Cause Analyses and process improvements to maintain ‘green’ metric status' - Liaise with other departments and client to ensure seamless process implementation and oversight for GCO in partnership - Act as key point of contact for GCO process internally and with client

• Manager, Strategic Partnerships; GMBA Canada

  • 2015 - 2016

  Toronto, ON • Hold multiple Business Process Lead positions for Registry Quality Control, SUSARs and Site Monitoring processes within the Pfizer partnership process group • Responsible for the adherence of global teams to these partnership wide metrics and processes • Provide SME support across business units as assigned BPL • Routine client counterpart meetings to ensure strong working relationship and alignment on processes • Design, update and implement new processes to global teams within… Show more • Hold multiple Business Process Lead positions for Registry Quality Control, SUSARs and Site Monitoring processes within the Pfizer partnership process group • Responsible for the adherence of global teams to these partnership wide metrics and processes • Provide SME support across business units as assigned BPL • Routine client counterpart meetings to ensure strong working relationship and alignment on processes • Design, update and implement new processes to global teams within the partnership • Liaise with multiple departments to lead process level updates • Participate in root cause analyses of process deviations and quality issues • General Manager of Business Administration (GMBA) Canada, responsible for all Canadian facilities and event management. • LEAN champion to lead initiatives within clinical operations and attend value stream analyses. • Business Intelligence Committee Member, representing Global Clinical Operations Management

• Manager, Global Clinical Operations; GMBA Canada; Registry Business Process Lead

  • 2012 - 2015

  Toronto, ON • Routinely managing 10 to 15 staff. Direct reports include NA Clinical Monitoring Associates (CMA) within the Pfizer Partnership and all Clinical Research Associates (CRA) within the Canadian Pfizer partnership. • Ensure successful performance and delivery of direct reports project deliverables, on time with high quality. • Responsible to resource client projects with suitably trained and experienced staff. • Provide clinical consultation and leadership to direct reports and project… Show more • Routinely managing 10 to 15 staff. Direct reports include NA Clinical Monitoring Associates (CMA) within the Pfizer Partnership and all Clinical Research Associates (CRA) within the Canadian Pfizer partnership. • Ensure successful performance and delivery of direct reports project deliverables, on time with high quality. • Responsible to resource client projects with suitably trained and experienced staff. • Provide clinical consultation and leadership to direct reports and project teams. • Assist in the review and response to audit findings, both client and regulatory, for project teams. • Conduct performance reviews and develop direct reports professional development plans. • Identify performance issues and implement performance improvement measures. • General Manager of Business Administration (GMBA) Canada, responsible for all Canadian facilities and event management. • Business Process Lead for Registry Quality Control (RQC) in the Pfizer Partnership. Responsible for partnership level registry metrics, systems parity and coordination of global RQC teams and weekly meetings with client counterparts. • Trained in LEAN methodology to champion LEAN initiatives within clinical operations and attend value stream analyses. Designed and developed tools for staff to adopt LEAN principles. • Business Intelligence Committee Member, representing Global Clinical Operations



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Senior Site Manager

  • 2010 - 2012

  Toronto, ON. Part of the Qunitiles Large Scale Functional Resourcing team which provides key site management services to Johnson & Johnson Global Clinical Operations group. Responsibilities involve the independent management of clinical trial site and personnel for the successful completion of key compound trials for Janssen Canada. Focused in Endocrinology and CNS Pain studies.



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research Associate

  • 2005 - 2010

  Responsible for the management of Canadian Clinical trial centers to successfully execute clinical project goals in a variety of therapeutic areas, for clinical trial phases II - IV. Therapeutic areas of experience include: Depression, Insomnia, Diabetes, Psoriasis, Cardiology, Osteo-Arthritis, Migraine and Pain. Perform qualification, initiation, monitoring and termination visits to ensure compliance with multiple protocols, FDA regulations, Health Canada regulations and GCP… Show more Responsible for the management of Canadian Clinical trial centers to successfully execute clinical project goals in a variety of therapeutic areas, for clinical trial phases II - IV. Therapeutic areas of experience include: Depression, Insomnia, Diabetes, Psoriasis, Cardiology, Osteo-Arthritis, Migraine and Pain. Perform qualification, initiation, monitoring and termination visits to ensure compliance with multiple protocols, FDA regulations, Health Canada regulations and GCP guidelines. Functioned the following additional roles CRA assessor, mentor, report reviewer, Parexcellence committee member and system super user. Extensive training for the clinical lead position with active responsibilities in monthly budget review, resource review and report review. Show less



Eli Lilly Inc

• Lead Clinical Research Associate. Internship

  • May 2005 - Sep 2005

  Managed aspects of both Global and Local Clinical trials in the therapeutic areas of Endocrinology, Critical Care, Men's Health and Neuroscience for Multiple Compounds. Managed the Canadian arm of a long term Global Observational clinical trial for patients with Hypopituiarism.



Parexel

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Specialist and Archivist

  • 2001 - 2003

  Verified adherence of the study team and other company personnel to study protocol, Standard Operating Procedures and other internal or sponsor standards.