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Work Background
EnnovProject Manager
Jan. 2022Kitchener, Ontario, Canada · Remote- Day to day management of regulatory software implementation projects for pharmaceutical and clinical trial customers.
- Creation of project management processes & tools to accommodate project delivery information in a growing company.
- Define KPI’s to measure project delivery and produce tools for their measurement.
- Development of project management training for delivery to the North America and Europe business units.
- Customer technical support both pre and post go-live.
Third Down ConsultingBusiness Owner
Dec. 2021Kitchener, Ontario, CanadaCreated own business to engage in Permanent Full-Time contract with Ennov.
fme US, LLCProject Manager - Principle Consultant
Mar. 2021 - Dec. 2021Danbury, Connecticut, United States (Decentralised from Canada)Management of regulatory data and document migrations into Veeva Vault.
- Migration scope including hundreds of products and millions of documents.
- Source systems: Register, Firstdoc, TRS Tracker, bespoke systems and spreadsheets.
- Project team included Migration Leads and business Analysts to design the migration, programmers to develop and implement and QA resources for verification design & execution.
- Internal reporting to COO level with monthly management team project review meetings.
Seeking New OpportunityProject, Program & Portfolio Manager Seeking Opportunities
Dec. 2020 - Mar. 2021Kitchener, Ontario, Canada
LIQUENT, a PAREXEL® CompanySenior Project Manager
Dec. 2019 - Dec. 2020Decentralised (Home Based)Returned to Parexel to provide leadership and direction to critical internal project work supporting key Regulatory Information Management (RIM) business changes.
Duties included:
• Responsibility for the RIM New Product Introduction (NPI) and Service Transition program for SaaS product delivery, interfacing with the software development SAFe process and collaborating with IT, engineering and professional services functions.
• Led risk management of product release issues, redefined the RIM NPI & Service Transition process for risk mitigation creating smoother transition to RIM services with a reduction in client complaints.
• Managed software and infrastructure delivery issues, using problem-solving skills to lead engineering and IT through timeline and resource profile redefinition and communication with senior executive stakeholders.
• Partnered with Product Management in building product introduction roadmaps.
• Owned the sales forecast scenario planning, partnering with the Business Development team to define the RIM operations program relating to client SaaS implementation projects.
• Assumed responsibility and leadership role for Project Management team as backup of Senior Director, managing day-to-day tactical delivery issues and using strong business acumen to direct the PM team in developing strategic project documentation, processes and tools. A unique experience to highlight for this role was using my product development and project delivery experience to look across the end-to-end solution offering and identify risks within business processes for the change to a SaaS offering from an on-premise product, resulting in the opportunity to lead a cross-company effort to realign the product development, IT development, professional services and business services requirements and associated delivery timeline, minimising the impact on the business and customer success.
OpenTextProject Manager
Nov. 2018 - Dec. 2019Waterloo, Ontario / Home BasedResponsible for delivery of multi-product content management stacks for Life Sciences customers with duties including:
• Be a strong partner, continually interfacing with customer project managers to ensure solution delivery and effective support for cross functional teams, and bringing team focus to internal team and leadership. • Strong business acumen required to work with global customers from requirements definition through design, build, validation and Production release.
• Concise regular communication both internally and to customers on progress, budget, resource forecasting, risks and issues.
• Strong leadership of remote project teams with internal and customer elements, including US, UK and India. An accomplishment to highlight in this role was my use of effective communication and resilience in managing customer expectations and influencing customer behaviour where project progress was being misrepresented along with a lack of teamwork and collaboration by the customer with my team. Using one-on-one meetings with the manager that was the apex of the issue, and changing approaches to information flow, I was able to hold the customer accountable to their decisions. Resulted in reducing issues reported which allowed my team to focus on project delivery.
Wilfrid Laurier UniversityRunning Backs Coach at Wilfrid Laurier University
Aug. 2018 - Nov. 2022Waterloo, Ontario, CanadaInitially assisting the RB Coach with individual drills, film review and game day group management.
Took over as position coach in 2019:
- Create skills, technique & physical development plans for each player in the group.
- Attend off-season lift sessions.
- Support Offensive Coordinator with scheme installation.
- Plan & lead individual sessions for Tailbacks, Fullbacks & Tight Ends during Spring Camp, Training Camp and in-season practices to align with the scheme aims of each session.
- Host daily practice film reviews, record reviews and provide to players where in-person was not feasible.
- Coordinate the groups pre-game warm-up & preparation.
- Coordinate scout Offence and Special Teams during in-season practices.
- Provide in-game adjustment feedback to Offensive Coordinator.
LIQUENT, a PAREXEL® CompanySenior Project Manager
Jul. 2013 - Oct. 2018Decentralised (Home Based)Experienced Program Manager leading a program of global regulatory management software & consultancy services projects. Also using process improvement skills with implementing continuous improvement for project delivery as well as integrating project delivery requirements to product development process. Duties included:
• Manage program of product implementation projects across global pharmaceutical and medical device businesses.
• Program manage multiple projects at larger pharmaceutical clients, acting as strategy driver and first point of issue escalation.
• Draft and negotiate contracts for project delivery – including legal, financial, scope and accountability aspects.
• Internal business process improvement projects in areas such as contracts, project delivery, knowledge management and processes.
• Maintain view of delivery pipeline, tying sales activity to delivery resource forecasts. An accomplishment while in this role was to bring forward investigation, problem-solving and negotiation skills while working with a large customer that had expressed dissatisfaction with response times, system performance, and was using power and politics to intimidate the overseeing Project Manager. Built a team of Subject Matter Experts (SME’s) which identified issues within the customer infrastructure and processes. Provided onsite consultation and support to customer IT and user teams, resolving the issues and providing evidence to the customer of the root cause. Resulted in improved processes and efficiencies to achieve the desired results of the system and product and an improved customer relationship.
Linde GasProject Manager
Jul. 2011 - Jun. 2013Home Based / Guildford OfficeManage a product development project to introduce new technology to medical gas delivery systems, leading a multi-national, multi-function project team and 3rd party development & production providers.
• Leadership of multi-function European project team with global distribution team members.
• Full planning responsibility, manage delivery of project tasks in each functional area, including 3rd party supplier.
• Restructure Quality Management process for project to meet business needs while reducing project team workload.
• Agree Regulatory approach for Pilot and Full launches, including work towards FDA Usability Guidelines.
• Agree design-for-production requirements internally and with suppliers.
• Supplier selection for plastic moulding, electronics and software production, including conducting selection audits.
Mandalore LimitedDirector
Jun. 2011 - Mar. 2014Managed own company while contracting for Linde Healthcare. Management Contracting or Consultancy - Project, Programme, Risk, Functional Team or Departmental. Experience in new product delivery, process implementation, risk management and problem resolution.
Philips AventSENIOR PROJECT MANAGER
Sep. 2009 - Jun. 2011Cambridge, United KingdomDelivery of New Product Development projects for global, high volume childcare consumer driven products. • Manage multifunctional teams that included Marketing, NPI (Industrialisation), Quality, Design, Cost Engineering, Mechanical Engineering.
• Utilise a risk management approach to shape project activities and timelines.
• Define required project budget, gain approval then manage spend and capital funding approvals.
• Integrate global development partners & manufacturers to projects for delivery of off-the-shelf or bespoke products.
• Define project scope and product requirements through Marketing inputs (inc. Value Proposition House & Voice of Customer Tree)
• Manage resolution of ad-hoc regulatory non-compliance issues, including in production line-stop situations.
Perkins Engines LimitedSENIOR PLANNING FACILITATOR
Jun. 2008 - Sep. 2009Peterborough, United KingdomManage off-highway diesel engine development project plan timeline creation, updates and reviews utilising Microsoft Project functionality and 3rd Party software.
• Increased proficiency in use of Microsoft Project and it’s application to run projects more efficiently.
• Facilitated Duration Driven planning sessions with internal, external and global project teams.
Bespak Europe LtdPROGRAMME MANAGER
Nov. 2006 - May. 2008King's Lynn, United KingdomManage a new drug delivery device product development. Program progressed from mould tool build to supply of customer clinical trial batches, with creation of clean-room manual assembly and moulding environments. • Leadership of project managers working on manufacturing readiness and customer specific tooling. • Personally manage projects for product design and business development.
• Manage capital (value ~£5M), overhead and labour budgets.
• Work with technical and project teams of major global pharmaceutical customers, including frequent travel for on-site meetings and presentations.
• Work directly with Managing Director and management team on establishment of new business approach.
Bespak Europe LtdSENIOR DEVELOPMENT ENGINEER
May. 2005 - Nov. 2006King's Lynn, United KingdomManaged project for development of unique elastomer compound, moving from development stage to frozen production formulation and validated process providing components for customer products.
Technical liaison for European customers of valves and actuators, providing supply of new product samples and regulatory information.
• Management of elastomer formulation and process development for unique compound, including hands-on production work.
• External supplier management for raw materials and process handover.
• Management of Drug Master File and associated regulatory data.
• Translating requirements to product specifications for new product developments.
• Bringing new valve and actuator designs to full production.
Bespak works to an ISO13485 quality system.
Huntleigh Healthcare LtdPROJECT MANAGER
Oct. 2002 - Apr. 2005Luton, United KingdomCreated the technical department & team for new business unit, managing and implementing a full ISO13485 Quality system and bespoke New Product Introduction & Project Management processes.
Project management and development of a commercial hardware/software based social monitoring system from University prototype to a regulatory compliant medical device, installed with early adopting customers. • Recruitment, management and development of technical department resources covering product development, production, quality and installation.
• Management of project task delivery, development activities and budget, circa £2M. • Customer management with regards to product requirements and on-site installation work.
• Application of in-depth risk management for each system and user.
• Design and implementation of Quality, NPD and Project Management processes as well as production line, controls and processes.
Huntleigh Healthcare LtdDesign Engineer
Sep. 1996 - Oct. 2002Luton, United KingdomVarious roles in medical device New Product Development. • Ownership of several medical device projects, managing them through development & regulatory approval to production. • Led Engineering Change Management team, handling over 50 engineering changes at any time
Huntleigh worked to an ISO9000/2000 quality system.
Britannia Airways LtdAircraft Engineering Apprentice
Sep. 1989 - Aug. 1993Luton, United Kingdom4-year indentured apprenticeship in mechanical engineering, servicing Britannia Airways fleet of Boeing 737, 757 & 767 aircraft.
• Dual trade Mechanical Engineering apprenticeship – Airframe & Engine
• Years 1 & 2 – General engineering skills and rotation through support service departments, from Stores to Composites
• Year 3 & 4 – Hands on servicing of all aircraft airframe & engine sections
• Block release ONC education through years 1 & 2
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