Alison Mitro Email & Phone Number

Toronto, Ontario, Canada

Altis Labs has created AI-powered software that predicts drug efficacy to accelerate clinical R&D. We've built the industry's largest proprietary imaging database to train AI models that predict efficacy.In my role as Head of Clinical Trial Solutions at Altis Labs, I lead Customer Delivery and drive the implementation of our software in our biopharma customers' clinical trials. I oversee proposal development, contracting, customer onboarding, environment set-up, trial planning, and implementation.

-Developed performance and risk dashboards to drive reporting to executive leadership on health status of key accounts-Established Project Management Office to launch initiatives focused on improving operational outcomes, enforcing executional structure across account teams, and streamlining delivery processes -Lead and supported cross-functional programs to support achievement of corporate strategic goals-Drove development and launch of new delivery programs with strategic vendor, included establishment of operating model, implementation of governance, finalization of contracting, etc. -Alliance lead for key account; including maintaining oversight of project teams, development of governance and performance metrics with customer counterparts, launch of workstreams

-Key driver in development of a scalable enterprise delivery strategy and operating model; including development of enterprise pricing, contracting, and resourcing models, development of customer training programs, and creation of operational playbooks that define standard processes-Supported enterprise engagements in the scoping and planning phase to establish targeted implementation strategies according to customers' needs and goals for an enterprise program -Acted as a Solution Expert working in close alignment with Commercial and Delivery teams to support enterprise proposals, pre-sales workshops, contracting, and deal manufacturing -Developed a delivery program supporting a new offering, including development of delivery operating model, budget and contracting structures, creation of a customer training program, development of internal reference materials and SOPs, etc-Key stakeholder in internal strategic and process optimization initiatives

Toronto, On (Remote)

-In collaboration with customer success teams, drove strategic activities critical to expansion of key customers, including facilitation of business transformation workshops, governance implementation, establishment of partnership key performance indicators and metrics, and delivery of training-Contributed to creation and development of training and certification programs

Toronto

Toronto, Ontario (Remote)

-Led global study start-up activities for assigned projects, including oversight of ethics submissions, regulatory authority submissions, management of import/export licenses, essential document collection, informed consent development, contract and budget negotiation, and study maintenance submission-Key projects included multiple Phase 3 studies involving over 13 countries each-Oversaw a team of regional study start-up leads, site start-up regulatory specialists, site contract negotiators, and site contract leads to drive sites through start-up on time, in compliance, and per client expectations -Developed and maintained projected timelines for global study start-up; presents study start-up timelines, strategies, risks, and action plans at client meetings and provides weekly reporting to internal and external stakeholders -Was accountable for project financials pertaining to study start-up, including monthly budget recognition, financial health reporting, work order review, etc, to ensure project profitability -Assisted project management and medical writing in the development of project master informed consent forms-Prepared and collates core clinical trial application dossier (core documents)-Provided regulatory support to business development with client face-to-face meetings like Project Kick-Off meetings and bid defenses

Toronto, Canada Area

-Led North America start-up management for key COVID-19 vaccine study; exceeded targeted site activation milestones while navigating frequently changing Health Authority guidance during pandemic-Earned Global Site Activation 2021 departmental award for "Most Impatient for the Patient" pertaining to success achieved on key study-Accountable for the execution of clinical trial start-up (pre-award phase, site identification, maintenance and investigational product release) for assigned projects. -Collaborated with internal and external project teams and clients to successfully implement a determined RSU plan and achieve project milestones across regions and countries. -Responsibilities included maintenance of clinical study approvals, authorizations, and negotiation of contracts, informed consent documents, and essential documents. -Identified regulatory challenges and develop practical solutions to ensure overall project efficiency, adherence to project timelines and financial goals, and high quality standards.

Montreal, Canada Area

-Single point of contact between investigative sites and project teams-Ultimately responsible for facilitating the start-up processes at investigative sites in adherence with regulatory requirements and project timelines-Experience with over 20 different clinical trial protocols at over 100 different research sites across North America, including Quebec sites with working French language requirements-Role involves facilitating the development of Informed Consent Forms that meet the requirements of both research ethics committees and the study sponsors, reviewing regulatory documentation for submission to regulatory agencies, and performing IP release.-Responsible for reviewing site performance metrics to establish project planning timelines, providing local expertise to project teams, and maintaining internal databases, systems and tracking tools.

Montreal

Hamilton, On

Assisted graduate and PhD students with the operation of an extensive and successful animal (rat) experiment to study the effects of lithium treatment on bipolar disorder in an enriched environment. Duties included daily animal care, data entry, and assistance with animal takedown and tissue preparation.Following the experiment, roles included tissue sonification, protein quantification and standardization using mass spectroscopy, tissue slicing using a Crysostat machine, Western blotting, conducting immunohistochemistry stains, and analysis of data. Daily roles included buffer preparation, purchasing supplies, lab care and cleanup, etc.

Bachelor Of Science (B.S.), Pharmacology

Other; Core Credential Of Readiness

CORe (Credential of Readiness) is a 150-hour certificate program on the fundamentals of business from Harvard Business School. CORe is.

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