• Handles all aspects of contract administration, specifically related to third-party awards in support of NMDP's research efforts. • Presents business strategies, agreements, subcontracts, grants and third-party awards to internal stakeholders to determine accurate contracting arrangements for research projects. • Prepares and reviews contractual documentation for third-party award submissions, both government and non-government; creates appropriate flow down terms and conditions for each award to be applied to future agreements. • Provides oversight to ensure that the EEO, FAR, OMB and related Federal requirements are incorporated, as required, into individual subcontracts/sub-agreements/purchase orders. • Assists with the preparation, negotiation, and maintenance of third-party awards by collaborating with internal partners to ensure deadlines are met, documents are updated, and projects are being conducted in accordance with any applicable agreement/award terms and conditions. • Supports NMDP's study networks (CIBMTR, BMT CTN, PTCTC) by negotiating and overseeing contracts throughout the life of a clinical trial; attends regular meetings to receive and provide updates on clinical trials. This role will be expected to provide contractual support to many aspects of a clinical trial, including funding agreements, laboratory agreements, clinical trial agreements, study riders, along with other contracts as required by the protocol or study team. • Advises key stakeholders about the legal and regulatory environment; identifies special arrangements, provisions, or legal/business requirements of the solicitation; defines and establishes agreements with third parties, including subcontractors. • Oversees or conducts negotiation of contracts and third-party awards; documenting discussions and using sound judgment and seeking the appropriate management approval for the acceptance of legal, financial and operational terms and conditions. • Safeguards NMDP’s intellectual property (IP) assets by using appropriate patent, trademarks, trade secret, and technical data/software agreements and provisions. • Develop, implement or modify Standard Operating Procedures (SOP) for contract management and administration in compliance with company policy. • As appropriate, contribute to or influence company policy. • Maintains contractual records and documentation and monitors compliance of established contract with internal stakeholders with established procedures. Responsible for the input and accuracy of procurement and contracting documents in an electronic database. • Conducts business with integrity, upholding high ethical standards in full accordance with contract requirements. • As needed, provides guidance on contract matters to internal stakeholders including training in contracting practices and procedures. • This role may focus on one or more of the following areas: procurement, contract support and prime contract/grant management.

• The Study Operations Manager I (SOM I) has responsibilities for study and regional or specific country level activities from study startup through conduct and study close on one or more studies, providing leadership, strategic planning, and organization skills to ensure the operational delivery of tasks. • Supports Global Study Managers (GSMs), other SOMs, and the larger study management delivery of the study by leading specific parts of the project, driving specific countries, executing tasks of moderate complexity, and developing solutions to problems as needed to support deliverables • Serves as leader of the local study team (core members, ad hoc members, and other key stakeholders as required) on one or more studies • Oversees the preferred Contract Research Organization (pCRO) and/or Country Trial Manager (CTM)/Site Care Partner (SCP) for assigned studies at country level in accordance with the overall project plan, and manages and maintains accurate country level plans (e.g., timelines, budget, risk, and quality plans) • May manage the study start-up process in countries assigned [where the Start Up Project Manager (SUPM) is not assigned] and/or oversee the pCRO responsible for these activities as applicable • Liaises with SCP, Lead SCP, Site Activation Partners (SAPs), and regulatory colleagues in country to agree on submission strategy to Health Authorities (HAs) and Ethic Committees (ECs) • Provides country level input on startup and recruitment milestones as provided by pCRO and/or CTM/SCP to GSM during planning • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required. • Accountable for resolution of site activation escalations to study teams including offering options for mitigation • May be responsible and accountable for, as designated by the GSM: Regional, country and study level recruitment strategy • Communication with the local team and internal stakeholders and pCRO as applicable to ensure efficient and timely study delivery of the agreed plans • Study and/or country vendor management and oversight including follow up and coordination of vendor deliverables • Assurance of the follow up and coordination of regional and site quality events, protocol deviations, data issues, metrics review, site issues and risks, audit responses, etc. • Acts as the point of contact for all study level questions for the local study team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles and teams • May lead operational effectiveness initiatives at country or regional level • Utilizes roles in country such as Lead SCP, and expert roles such as Contracts Leads and SAPs, to provide the global teams with local intelligence and operational nuances to be considered • Provides input on country level per subject costs, local vendor costs, and other fees where applicable • Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan and Study Monitoring Plan, and ensures Trial Master File (TMF) completeness and oversight of all relevant compliance activities for allocated studies • Supports implementation of client’s site technology experience systems • Supports implementation of new tools and technologies (e.g., eConsent, eISF, remote source access, remote source data verification/review (SDV/SDR), iConnect, implementation of protocol required decentralized trial options)

• Coordinate and oversee the operational aspects of a study including planning, start-up, enrollment and close out activities ensuring that deliverables are completed on time, within budget, and in compliance with department procedures, applicable regulations and quality standards • Prepare, review and implement study related plans and documents including project timelines, study protocols, informed consent forms (ICFs), recruitment plans, monitoring plans, study budgets, site contracts & budgets, vendor management plans and other essential clinical study documents • Develop plans for systems and materials required to support the efficient execution of clinical studies and is responsible for effective management during the conduct of the study • Develop, implement and maintain tools to manage, monitor and report on study health & operations, project timelines, and study finances to department management and other stakeholders • Participate in study database development by reviewing and contributing to case report form (CRF) design, CRF completion guideline development, edit check & manual data review requirements, and participation in user acceptance testing (UAT) • Oversee sample management activities including planning, sample handling, kit supply management, sample shipping, processing, and resulting • Develop site recruitment plans and is responsible for the identification, selection, start-up and performance monitoring of clinical research sites • Develop study budgets and is responsible for accurately forecasting and managing study expenses • Oversee site contracting and study budget management including facilitation of site contract and budget negotiations, invoice review and approval, accrual management and maintenance of budget tracking tools • Oversee study and site management activities such as, training, data entry & query resolution, TMF maintenance, and ensure compliance with study plans such as the study protocol, monitoring plans, and recruitment plans • Conduct monitoring activities as needed • Ensure the smooth and efficient closure of studies through development of plans for completion of data verification & review, planning & facilitation of database lock activities, determination of site & IRB/EC readiness for closure, statistical analysis and clinical study report development • Participate in the identification, qualification, selection and management of vendors providing support to clinical studies • Provide oversight and support for assigned clinical operations study team members • Leads cross-functional team meetings, ensuring study goals and priorities are clear. • Professionally interacts with investigators and site staff, vendors, key opinion leaders and consultants • Ability to identify, mitigate and manage study risks • Responsible for maintaining ongoing study audit readiness and participates in internal or regulatory authority audits • Provide guidance and support to less experienced team members • Fosters a collaborative and knowledge-sharing environment, promoting continuous learning within the team • Ability to provide oversight to multiple studies • Participate or may facilitate department or project initiatives under the direction of department management or lead clinical trial manager • Uphold company mission and values through accountability, innovation, integrity, quality and teamwork • Support and comply with the company’s Quality Management System policies and procedures • Maintain regular and reliable attendance • Ability to act with an inclusion mindset and model these behaviors for the organization • Ability to work a designated schedule • Ability to work on a mobile device, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day • Ability to work on a computer and phone simultaneously • Ability to travel 20% of working time away from work location, may include overnight/weekend travel. • Ability to attend off-site meetings and conferences as needed

Position Summary The Clinical Research Engineer is responsible for: - Gaining an in-depth knowledge of OrganOx FDA approved and investigational or research products, as well as associated clinical procedures - Serving as the subject matter expert on the device and procedures during IDE studies and research projects - Supporting training of OrganOx employees (e.g. Clinical Specialists) and customers on OrganOx approved, as well as IDE and research products and studies Major Responsibilities Under direction from the VP, Clinical Affairs and Training, the Clinical Research Enginer will be responsible for: ***Product Knowledge and Training*** · Gaining an in-depth knowledge of OrganOx FDA approved and investigational/research products, as well as associated clinical procedures - Support the development of training and other support materials for FDA approved and investigational/research devices and procedures - Train investigational/research centers, Clinical Specialists, and other OrganOx personnel on investigational/research devices and procedures - Attend cases with investigational/research device as a technical and clinical resource for the staff at the investigational/research center - Interface with Development and Engineering in order to obtain answers to technical questions - Provide clinical and technical feedback on FDA approved and investigational/research device to Development and Engineering ***Clinical Studies*** - Serve as a resource to investigational/research centers, as well as OrganOx personnel, regarding investigational/research devices and clinical study protocols - Support the development of clinical study protocols - Support sound and thorough data collection ensure data analysis in accordance with the protocol - Develop training and other support materials for clinical protocols, study procedures, data collection and review - Assist in the development and implementation of a study-specific database for clinical studies - Assist Clinical Research Associates with review of study data - Support writing and review of clinical study reports and the clinical portion of FDA submissions - Identify and report study protocol challenges and compliance issues to clinical management ***Management support*** - Support OrganOx in maintaining current and developing professional relationships with investigators and investigational/research sites - Serve as a resource to clinical management for departmental decisions related to continuing quality improvement of process and procedures - Other duties as assigned by VP, Clinical Affairs & Training