The O'Connor Group

• Providing leadership and support as it pertains to the operation of toxicology, ADME-PK, and bioanalysis • QCs on non-clinical study (GLP or non-GLP) protocols and reports, and study record and study material management constitute a great portion of this role • Track study milestones and deliverables for internal reporting and management • Serve as a primary liaison among nonclinical team, legal and finance to facilitate contract placement and execution promptly • Track invoices and ensure timely payment in coordination with the finance group • Support budget tracking and forecasting for all relevant studies • Assist with literature research, and regulatory and submission readiness support as needed • Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

• Lead operational contact for clinical studies • Provide strategic and operational leadership to the clinical operations team • Ensure project milestones delivery on time, within budget, high quality, and in compliance • Responsible for all operational aspects, strategic input, and progress of clinical trial • Manage vendor activities to support clinical studies • Oversee study timelines and budget planning • Participate in country and site feasibility/selection process • Ensure studies are 'inspection ready' at all times • Create and foster strong strategic partnerships with colleagues

• Develop and implement clinical operations strategies to support the company's product pipeline, ensuring alignment with corporate goals and objectives • Lead and oversee the strategic planning, implementation and execution of clinical trials in accordance with project timelines, budget, and quality standards • Develop and manage comprehensive site management plans, including but not limited to, study protocols, clinical trial budgets, timelines, enrollment and risk mitigation strategies • Collaborate cross functionally with internal teams to ensure the alignment on clinical trial objectives and milestones and the successful execution and monitoring of clinical trials • Serve as the point of contact for CROs and vendors, overseeing their site management performance and ensuring adherence to contractual agreements, timelines and quality standards • Track accrued site operations and monitoring expenditure against the actual budget for each program • Ensure compliance with regulatory requirements, ICH-GCP requirements, and company SOPs throughout all stages of clinical trial conduct • Oversee the collection, analysis and interpretation of clinical trial data, working closely with Clinical Development, Biostatistics and Data Management teams to ensure data accuracy and integrity • In collaboration with the Head of Clinical Operations, hire, train, develop, and mentor the Clinical Operations/Clinical Research Associate team, fostering a culture of collaboration, accountability, continues improvement, and operational excellence • Identify and solve problems that may arise during the trial • Continuously evaluate and improve clinical trial processes

• Deliver expert consulting and technical assistance to state, local, and tribal governments. • Support HUD grantees with financial management, compliance and reporting in DRGR and IDIS. • Lead discussions on policy and regulatory matters. • Create tools and templates to improve DRGR/IDIS accuracy, efficiency, and user management. • Design and deliver engaging and accessible training to HUD grantees and subrecipients.

• The Sr. CTM is the lead operational contact for the study and provides strategic and operational leadership to the clinical operations team to ensure project milestones delivery on time, within budget, high quality, and in compliance with the ICH/GCP, regulatory authority’s regulations/guidelines, and applicable SOPs. • Responsible for all operational aspects and progress of assigned clinical trial from a study planning activity to study execution including ongoing tracking all applicable performance metrics and quality indicators for milestone deliverables • Provide expertise and operational input into protocol synopsis, final protocol and other study related documents • Participate in country and site feasibility/selection process • Create and maintain timelines to meet the needs of the assigned clinical study(ies) • Ensure new team members and vendors are onboarded • Lead the development of the operational strategy in preparation for review; focus on ensuring accurate assumptions are applied and risk management plans are in place • Provide guidance to CRO/vendor to ensure study issues are addressed and resolved • Work to ensure that budgets, enrollment, and gaiting are maintained and accurate; communicate study status, cost and issues to Project Leader(s); serve as escalation point for vendors or other CROs • Support CRO/vendor selection, budget and contract negotiation, and proper guidance of performance for all activities assigned to a CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted • Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages • Approval of essential monitoring documents/plans, periodic review of outputs and actions related to monitoring • Review and endorsement of relevant study plans, as applicable • Study team meeting management and attendance; regular review of meeting agendas and minutes • Review outcomes/actions related to protocol deviations review; primary purpose of review is to help identify trends across sites or the study • Documented review and monitoring of risks and decisions at the study level and implementation of mitigation strategies • In partnership with data management, review and pressure test all database timelines and plans; ensure linkage between the strategy (i.e., filing/registration, data generation) with the tactical plan for database lock and CSR • Ensure studies are "inspection ready" at all time; may be involved in regulatory inspections by preparing for and attending the inspections • Represent Clinical Operations Manager role in functional projects or working groups • Help with onboarding and mentoring of new Clinical Operations Team members • Participates in the development, review, and implementation of departmental SOPs, initiatives and processes • Reviews/approves vendor invoices for all clinical trial vendors including investigative sites

• Provides operational support to the program lead to ensure project milestones delivery on time, within budget, with high quality, and in compliance with the ICH/GCP, regulatory authority’s regulations/guidelines and applicable SOPs. • Manage essential clinical trial duties and responsibilities as independently as possible, with guidance and oversight provided by leadership when needed. • Responsible for all operational aspects and progress of clinical trial from study planning activities to study execution including ongoing tracking of performance metrics and quality indicators. • Serves as an escalation point and resource for study team and investigational sites. • Proactively manages/identifies potential study issues/risks and recommends/implements solutions with key internal/external stakeholders. • Provides operational and strategic input and/or approves study documents such as synopsis, protocol, ICF, CRFs, CRF Completion Guidelines, Study Plans, Clinical Study Report (CSR) development, etc. • Responsible for management of data management and clinical operations teams in review of clinical data; provides guidance on issues/queries as needed and implements risk management concepts as appropriate. • Responsible for and participates in clinical vendor selection process as a part of outsourcing activities. • Provides oversight for all vendor operational activities (e.g., study management, monitoring, specifications development, UATs, issues escalations). • Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages. • Creates, manages, measures, and reports timelines for milestone deliverables. • Oversees/facilitates site feasibility/selection processes. • Develops/oversees subject recruitment/retention strategy and related initiatives. • Oversees internal team meetings, investigator meetings, and other trial-specific meetings. • Participates in the development, review, and implementation of departmental SOPs, initiatives and processes. • Reviews/approves vendor invoices for all clinical trial vendors including investigative sites.

• Lead efforts to grow consulting solution areas by identifying and nurturing new opportunities • Develop and execute a strategic business development plan focused on expanding our footprint with rare and specialty disease drug developers • Cultivate and manage executive-level relationships across client organizations • Identify high-value opportunities aligned to Ambit's capabilities • Own the sales cycle—from prospecting and lead qualification through proposal development, pitch delivery, and contract negotiation • Collaborate with delivery leads to design compelling solutions and ensure smooth handoff into project execution • Represent Ambit at industry conferences, networking events, and thought leadership forums • Track pipeline metrics, revenue, target achievement, and provide insight into market trends and client needs • Contribute to firm strategy and marketing efforts

• Lead analytics engagements across sales effectiveness, marketing analytics, omnichannel strategy, customer targeting, and market access—linking analyses to clear decisions and actions. • Frame ambiguous commercial questions into structured analytical approaches, hypotheses, and decision frameworks; facilitate whiteboarding sessions to align stakeholders quickly. • Design, prototype, and scale new analytics solutions tailored to client priorities; convert pilots into repeatable programs and sustainable operating models. • Serve as a senior advisor to client leaders; lead executive readouts, strategic working sessions, and roadmap planning. • Own growth and expansion within assigned accounts: identify opportunities, shape demand, develop proposals, and drive adoption of new capabilities. • Build and manage expansion pipeline: convert stakeholder conversations into concrete workstreams and measurable revenue impact. • Lead and mentor multi-disciplinary teams (analysts, data scientists, consultants, data engineers, BI developers); set standards for analytical rigor, storytelling, and client communication. • Partner cross-functionally to ensure solutions are scalable, documented, and aligned to governance, compliance, and data standards.

• Oversee the Company's global accounting operations, ensuring the integrity of financial reporting, compliance with U.S. GAAP, and efficiency in multi-entity consolidations, reporting and compliance. • Lead the global accounting function across U.S., Canadian, and Indian entities. • Ensure timely and accurate financial close, consolidation, and reporting in compliance with U.S. GAAP. • Develop and maintain accounting policies, internal controls, and financial procedures. • Coordinate with external auditors and manage annual audits. • Manage sales tax registration and compliance processes for software products in jurisdictions where they are taxable. • Oversee accounting system infrastructure and participate in system upgrades or ERP transitions. • Coordinate the development, compilation, and reporting of annual budgets and rolling forecasts. • Lead and mentor the global accounting team in India. • Collaborate with FP&A, operations, and other departments to ensure financial alignment across the business.

• Define and execute the technology strategy and roadmap aligned with business objectives • Architect scalable, secure, and maintainable systems across the technology stack • Make critical technology decisions on frameworks, platforms, and infrastructure • Establish and enforce engineering best practices, coding standards, and development methodologies • Drive technical innovation while maintaining system stability and performance • Contribute to critical features and technical initiatives through direct coding • Conduct code reviews and provide technical mentorship to engineering teams • Troubleshoot complex technical issues and production incidents • Maintain deep understanding of the codebase and technical architecture • Build, mentor, and grow a high-performing engineering team • Foster a culture of collaboration, continuous learning, and technical excellence • Conduct performance reviews, career development planning, and technical coaching • Recruit top technical talent and establish effective hiring processes • Partner with product, design, and business stakeholders to translate requirements into technical solutions