Innovaderm Research Inc.

• Manage day-to-day operations of an assigned team in Clinical Operations • Oversee performance, coaching, and training of Clinical Research Associates and support personnel • Ensure proper monitoring and compliance with SOPs, GCP, and regulatory requirements • Drive resources allocation and monitor adherence to project timelines and quality metrics • Identify quality issues and establish corrective action plans • Support training development and conduct assessments of clinical operations personnel

• Ensures that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements; • Identifies quality issues and trends related to site performance and clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, quality control visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions; • Serves as a point of contact for CRAs and Lead CRAs for assigned projects; • Provides mentoring/oversight of CRAs and Lead CRAs; • Performs site visit report review for assigned projects and tracks site visit report metrics to ensure compliance; • Contributes to the development of the Clinical Monitoring Plan; • Prepares and conducts project-specific training for the CRAs; • Develops the annotated site visit reports and monitoring tools such as source data verification worksheets; • Conducts quality control visits with CRAs; • Coordinates and leads CRA meetings; • Performs co-monitoring visits with CRAs; • May be involved in business development activities (client meetings, proposal defense meetings, requests for proposals (RFPs) requests for information (RFIs)).

• Oversees Ethics Committee (EC), Regulatory Authority (RA), and other submissions to ensure compliance and timely delivery. • Provides leadership for assigned projects and regulatory support to project teams. • Prepares/reviews core packages and country packages for RA submission. • Prepares, manages, and tracks IRB/IEC submissions as primary point of contact. • Peer review of documents prepared by regulatory team colleagues. • Reviews regulatory documents created by subcontractors for quality before submission. • Acts as point of contact for regulatory bodies and local teams regarding submissions. • Reviews and prepares study-specific regulatory documents/forms. • Manages translations with vendors and oversees submission of SUSARs. • Participates in meetings, audits, and project-related activities. • Ensures TMF completeness through timely document submissions. • Provides leadership and management to direct reports, including goal setting and mentoring. • Participates in process improvement initiatives and other assignments as required.

• Coordinate regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions • Provide regulatory support and advice to project teams; provides project-specific local submission strategy and technical expertise • Provide guidance to the client on submissions strategies • Prepare/review core packages and country packages for submission to RA (initial applications, amendment packages, and notifications) in assigned countries to ensure compliance • Prepare, manage, and track IRB/IEC submissions (including renewals); acts as the primary point of contact for the central IRB/IEC • Peer review of documents and packages prepared by colleagues within the regulatory team • Review regulatory documents and submissions created outside of the company by subcontractors (e.g., partner CROs, regulatory vendors) to ensure high quality standards before submission to RA and IEC • Point of contact for regulatory body and IRB/IEC, Sponsors, investigative sites, subcontractors, and local teams for all aspects related to study regulatory submissions • Develop/review Master Informed Consent Form (ICF), as applicable, and Country ICFs • Review site-level Informed Consent form documents as needed • Prepare or review study-specific regulatory documents/forms • Manage/oversee translations and requests with vendor • Submit and track SUSARs to RA, EudraVigilance, IRB/IEC, and Investigators, as per study scope • Perform regulatory review of essential documents and authorizes regulatory release prior to the shipment of investigational product to clinical sites • Review country-specific labelling content for clinical trial drug supplies to ensure conformity with regional regulations requirements • Participate in Kick-off meetings, client audits, and other project related meetings according to the company / client needs • Submit documents to TMF in a timely manner during the trial and ensures the TMF is complete for assigned sections by performing completeness reconciliation • Communicate activities performed out-of-scope to project team members and provides them with budgeting details related to said activity • Maintain high level knowledge about regulations in the area of company interest • Participate in function and/or corporate initiatives and special project assignments • Support Regulatory Country Intelligence activities • Communicate/liaise with regulatory agencies/competent authorities and/or other regulatory or functional experts on designated regulatory activities as required • May provide presentations, training or help to develop tools and processes for the Regulatory Team or other cross-functional teams • Provide line management to direct reports, including new-hire orientation, professional development, performance appraisals, and employee counseling/mentoring • Management and coordination of resources and workloads of direct reports • Supports staff by establishing goals that will increase knowledge and skill levels and by delegating tasks commensurate with skill level • Promote a positive work environment and motivate the team to achieve organization goals • Participate in the hiring process of new employees • Provide leadership and implement productivity improvements to ensure optimal utilization of resources • Participate in process improvement initiatives

• Responsible for the operational management and oversight of clinical investigative sites and clinical monitoring deliverables of clinical trials • Ensures that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables • Identifies quality issues and trends related to site performance and clinical monitoring activities • Summarizes findings and establishes action plans for corrective actions • Serves as a point of contact for CRAs and Lead CRAs for assigned projects • Provides mentoring and oversight of CRAs and Lead CRAs • Performs site visit report review for assigned projects • Contributes to the development of the Clinical Monitoring Plan • Prepares and conducts project-specific training for CRAs • Develops annotated site visit reports and monitoring tools • Conducts quality control visits with CRAs • Coordinates and leads CRA meetings • May be involved in business development activities

• Execute the enterprise AI strategic roadmap. • Identify, prioritize, and sequence AI use cases based on value, feasibility, and risk with upper management. • Support AI governance frameworks and responsible AI practices. • Monitor AI market trends, emerging technologies, and competitive landscape. • Collaborate with Technology, Data, Security, and business stakeholders. • Support AI adoption through enablement, training, and communication initiatives. • Prepare executive-level presentations and AI progress updates. • Execute the vision for data, AI and augmented productivity across Copilot solutions (M365 Copilot, Copilot Studio among others), aligning these initiatives with customer needs and strategic objectives. • Prepare and lead requirements gathering workshops and create detailed requirements documentation. • Oversee the large-scale deployment of Microsoft 365 Copilot and Copilot Studio agents to existing customer systems and internal departments (Finance, HR, Legal, Operations, etc.) • Design and oversee the development of conversational agents and automated applications using low-code/no-code tools, including the Power Platform. • Identify and prioritize high-impact use cases. • Support the implementation of an AI usage framework focused on ethics, transparency, security and regulatory compliance of data and AI initiatives. • Train end-users, popularize technical concepts to stakeholders, including executive management, and act as ambassador-driver of digital innovation through AI adoption. • Oversee the documentation of processes and solutions to ensure their scalability and sustainability. • Lead multi-disciplinary and cross-industry projects, ensuring alignment with corporate strategy, including tracking adoption, creating a business case and reporting to customer management, as well as proposing project budgets for approval and tracking costs throughout project lifecycle. • Communicate with vendors as required for project needs.

• Gather, analyze, and document business requirements from internal stakeholders • Translate operational needs into functional system requirements • Challenge and refine requests by proposing best‑practice solutions aligned with system capabilities • Ensure requirements are well understood, prioritized, and clearly documented • Configure and maintain enterprise applications such as ERP, HRMS, Timesheet systems, CRM, Internal custom developed software • Leverage standard features and best practices to meet business needs • Ensure configurations are scalable, maintainable, and aligned with company standards • Participate in system upgrades, releases, and testing activities • Maintain strong knowledge of supported systems’ functionalities and limitations • Advise business users on optimal usage of systems and process improvements • Promote standardization and reduce unnecessary customization where possible • Contribute to system documentation, user guides, and process flows • Identify gaps between business requirements and system capabilities • Document functional specifications for system enhancements or custom developments • Collaborate with development teams by providing clear, complete, and testable requirements • Participate in user acceptance testing (UAT) and validation of delivered solutions • Act as a trusted partner for internal users • Explain functional solutions in non‑technical terms • Support issue resolution, root cause analysis, and continuous improvement initiatives

• Overseeing and managing the successful and timely activation of clinical trial sites across multiple countries • Leading all start-up activities and ensuring regulatory compliance • Collaborating with cross-functional teams to meet study timelines and client expectations • Defining start-up strategy and timelines in collaboration with the Project Manager and cross-functional leads • Preparing and maintaining a site activation plan • Proactively identifying and communicating issues impacting delivery • Monitoring progress against timelines and addressing delays or risks • Overseeing and coordinating each step of the start-up process • Serving as the primary liaison among all functions involved during the start-up period • Tracking and reporting start-up performance metrics • Leading client-facing calls and serving as main point of contact for start-up activities

• Overseeing and managing the successful and timely activation of clinical trial sites across multiple countries • Leading all start-up activities, ensuring regulatory compliance, and collaborating with cross-functional teams to meet study timelines and client expectations • Managing the end-to-end study start-up process, including site selection, regulatory submissions, site contracting and budgeting, and site activation • Defining start-up strategy and timelines in collaboration with the Project Manager and cross-functional leads • Preparing and maintaining a site activation plan • Proactively identifying and communicating issues impacting delivery and providing proposed solutions • Monitoring progress against these timelines and proactively addressing delays or risks • Serving as the primary liaison among all functions involved during the start-up period • Tracking and reporting start-up performance metrics

• Manage the end-to-end study start-up process, including site selection, regulatory submissions, site contracting and budgeting, and site activation • Define start-up strategy and timelines in collaboration with the Project Manager and cross-functional leads • Prepare and maintain a site activation plan, ensuring selected sites and countries optimize opportunities for successful study delivery • Proactively identify and communicate issues impacting delivery and providing proposed solutions • Monitor progress against these timelines and proactively address delays or risks • Oversee and coordinate each step of the start-up process to ensure activation goals are met • Serve as the primary liaison among all functions involved during the start-up period, ensuring effective cross-functional communication and collaboration • Track and report start-up performance metrics, providing transparency and accountability • In partnership with PM, lead client-facing calls and serve as the main point of contact for start-up activities with both internal teams and Sponsors