Celerion

Title: Medical Monitor Location: Remote - US Department: 4111 - Early Clinical Research – 4111.4200 - Clinic Job Description: Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion is a Contract Research Organization (CRO) specializing in Phase I and early-phase clinical trials, including first-in-human (FIH) studies, bioequivalence/bioavailability studies, and specialized populations research. We partner with pharmaceutical and biotechnology sponsors to safely and efficiently advance new therapies through clinical testing. Position Summary The Medical Monitor provides physician-level medical oversight for early-phase clinical trials conducted at our Clinical Pharmacology Units. This role is responsible for safeguarding participant safety throughout study conduct, including screening/eligibility review, real-time clinical decision-making during dosing and confinement periods, adverse event (AE) and serious adverse event (SAE) assessment, and dose-escalation safety review in collaboration with Sponsors and Safety Review Committees (SRCs). The Medical Monitor serves as the primary point of medical contact for principal investigators, study staff, and sponsors regarding participant safety and eligibility decisions. Key Responsilities Participant Safety & Clinical Oversight - Provide on-call medical coverage during screening, check-in, dosing, and confinement periods for Phase I studies, including FIH and healthy volunteer trials. - Review and approve subject eligibility based on medical history, physical examination, laboratory results, ECGs, and protocol-specified inclusion/exclusion criteria. - Respond promptly to medical emergencies and adverse events during study conduct; direct emergency management and escalation to higher levels of care when necessary. Dose Escalation & Safety Review - Participate in Safety Review Committee (SRC) meetings and provide medical input on dose-escalation decisions for FIH and multiple ascending dose (MAD)/single ascending dose (SAD) studies. - Review real-time safety data (vital signs, labs, ECGs, PK data where applicable) to inform stopping rules and dose-escalation criteria. - Communicate safety findings and recommendations to Sponsors, the Principal Investigator (PI), and the Institutional Review Board (IRB)/Ethics Committee as required. Protocol & Regulatory Support - Review study protocols, informed consent forms, and safety monitoring plans for medical and scientific accuracy prior to study initiation. - Ensure medical procedures comply with Good Clinical Practice (GCP), ICH guidelines, FDA regulations (21 CFR), and applicable local/national regulations. - Support development of medical monitoring plans and safety narratives. - Serve as medical liaison during sponsor audits and regulatory inspections. Cross-Functional Collaboration - Collaborate with the Principal Investigator, Sub-Investigators, Clinical Research Coordinators, nursing staff, and Pharmacovigilance/Safety teams. - Provide medical training and guidance to clinical staff on protocol-specific safety procedures. - Participate in investigator meetings, sponsor teleconferences, and internal safety review discussions. Required Qualifications - M.D. or D.O. degree from an accredited medical school, with an active, unrestricted medical license. - Minimum 5 years of clinical experience in a medical setting. - Minimum 2 years of experience in clinical research, clinical pharmacology, biotechnology, or CRO industry. - Working knowledge of ICH-GCP guidelines, FDA regulations, and human subjects protection requirements. - Strong understanding of pharmacokinetics/pharmacodynamics (PK/PD) principles as they relate to dose-escalation safety decisions. - Excellent written and verbal communication skills, with the ability to produce clear safety narratives and communicate effectively with sponsors, regulatory bodies, and multidisciplinary teams. - Proven ability to make timely and sound medical decisions based on complex clinical data. - Detail-oriented approach with the ability to multitask and manage priorities in a fast-paced environment - Strong leadership qualities with the ability to mentor and guide junior staff members. Preferred Qualifications - Prior experience serving as a Medical Monitor, Principal Investigator, or Sub-Investigator on Phase I/First-in-Human studies. - Experience presenting at or participating in Data Safety Monitoring Boards (DSMBs) or Safety Review Committees. Working Conditions - Primarily remote; however, in-person training will be required. Occasional travel may also be required Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

• Data analysis and interpretation • Perform PK analyses independently • Assist with PD analyses • Interpret PK and statistical results and findings independently • Perform QC reviews as assigned • Write and review reports as assigned • Prepare PK data/report files for electronic filing of projects for submission to regulatory agencies • Maintain and file all supportive documentation pertaining to the study and ensure proper archiving of projects • Other responsibilities • Interact with clients alongside or under direction of a senior scientist, as needed • Prepare internal presentations

• Responsible for defining and executing the enterprise technology strategy for Celerion. • Oversee infrastructure, cybersecurity, enterprise applications, digital transformation, data platforms, laboratory systems, and regulated technology operations supporting Celerion’s global operations. • Partner closely with executive leadership, operations, quality, regulatory, and business development teams to ensure technology capabilities enable operational excellence, regulatory compliance, scalability, innovation, and exceptional client experiences across all global sites. • Develop and execute a multi-year global technology roadmap aligned with corporate objectives and growth strategy. • Lead enterprise-wide digital transformation initiatives supporting clinical, laboratory, and business operations. • Advise executive leadership on emerging technologies, cybersecurity risks, AI opportunities, automation, and data modernization. • Build strong relationships with operational leaders to ensure technology solutions improve efficiency, quality, and customer experience. • Establish technology governance, architectural standards, and investment prioritization processes. • Oversee global IT infrastructure including cloud platforms, data centers, networks, endpoint management, collaboration tools, and telecommunications. • Ensure high availability, disaster recovery, business continuity, and operational resilience across global locations. • Lead modernization of legacy systems while minimizing operational disruption. • Direct global service desk and support operations with measurable SLAs and customer satisfaction metrics. • Responsible for cybersecurity strategy, risk management, incident response, and security operations. • Ensure compliance with GxP, FDA, GDPR, SOC, ISO, and other applicable regulatory frameworks. • Partner with Quality and Regulatory teams to support computerized system validation and maintain audit readiness. • Oversee security awareness, vulnerability management, identity management, and third-party risk programs. • Drive enterprise data strategy including governance, analytics, reporting, and AI-enabled insights. • Ability to manage infrastructure and optimize operational efficiency while balancing innovation, risk and cost management. • Lead evaluation and implementation of scalable technology platforms supporting global expansion. • Manage global technology budgets, forecasting, contracts, and software licensing. • Negotiate strategic vendor relationships and technology partnerships. • Establish KPIs and reporting mechanisms to measure technology performance and value realization. • Build and lead a high-performing global technology organization. • Foster a culture of accountability, innovation, collaboration, and continuous improvement. • Lead geographically distributed teams across multiple time zones and business functions. • Drive the identification, incubation, and commercialization of AI capabilities that strengthen competitive positioning, accelerate growth opportunities, and enhance enterprise value.

• Serve as a subject matter expert in Veeva Clinical Data Management Suite (CDMS), including Veeva Electronic Data Capture (EDC) and Veeva Clinical Database (CDB) • Perform all activities related to eCRF design and EDC build programming for assigned projects • Perform EDC edit check programming for assigned projects based on edit check specifications for both simple and complex edit checks • Create test data to verify both screen design and edit check programming prior to deploying to User Acceptance Testing (UAT) • Set up test environments and coordinate project team members for execution of test scripts • Program and configure listings and reports using clinical reporting tools such as Veeva Clinical Database (CDB) • Ensure secure and high-integrity database imports from vendor transfers using Celerion data transfer standards • Assist with the validation of upgrades to hardware/ software including validation documentation development, review and execution. • Maintain global clinical trial database standards (CDISC)

• Manages multiple clients and their associated projects, fostering relationships with assigned clientele • Confirms each project’s scope in conjunction with the client and operational teams to ensure adherence to contractual scope, timelines and budget for all team members • Engages assigned team and functional managers in the development, assignment and prioritization of work based on the project’s needs, taking corrective action with Operations as appropriate to control project scope and cost • Fosters high-level of communication by conducting frequent project meetings, initiated at project inception and continuing through project closeout • Creates or reviews and maintains project-related documentation including: RFIs, Budgets, Meeting Minutes, Timelines, Client Isms, Issues and Risk Lists, Change Requests, etc. • Implements change management where appropriate to alleviate bottlenecks, improving processes and procedures to enhance the efficiency and effectiveness of the organization • Updates relevant databases required to maintain and report on current project statuses and overall financial reporting • Hosts client visits and conducts facility tours

• Support day-to-day management of studies, ensure within the Study Team that project/study tasks are delivered in time, within the budget, and according to Sponsor/Client expectations, in close cooperation with designated Project Team • Support the implementation and maintenance of studies; assist so that Sponsor and Investigator obligations are met and are in compliance with applicable regulatory requirements (including local law) as well as Good Clinical Practice • Support in document management (creation, review, collection, filing, forwarding) including submission documents, meeting minutes and Trial Master Files, from Pre-study Phase to Study Closure • Support (field) monitors by (but not limited to) preparing checklists, controlling completion status and timelines, updating relevant tracking sheets • Create, review, finalize, forward and file meeting minutes for all internal and external study-related meetings. • Support in Celerion process improvement • Support in-house in performing site feasibility and site qualification visits in order to select qualified sites • Support to prepare documents for Site Initiation Visits (SIVs), such as presentation slides • Support to prepare documents for Monitoring Visits • Support to prepare documents for Close-out Visits • Perform content review and quality checks of received documents • Cooperate with central TMF team to keep Trial Master File (TMF) up-to-date and track filed documents • Support query resolution in a timely manner • Support Serious Adverse Event (SAE) reporting according to study specifications • Support in document/review study status, site enrolment status • As a member of Celerion’s project teams, perform billable work in accordance with Celerion BCDs, SOPs and PGs, and within the relevant timelines • Interact with Sponsor/Client and participate in Sponsor/Client meetings as necessary • Participate and demonstrate proactive involvement in project/study meetings, internal project/study meetings, and other activities enhancing project progress • Participate in audits and inspections, including preparation and follow-up activities • Support Sponsor/Client in fulfilling their obligations with regard to submissions according to relevant regulatory requirements

• Lead the initiation, maintenance and close out activities of multi-center studies in accordance with the protocol, relevant SOPs, Good Clinical Practice, international standards, and regulatory requirements • Plan and procure team resources as needed to complete study activities according to scope, budget, and timeline • Develop and/or oversee development of study plans such as project management (including communication), monitoring, risk management, data management and safety plans • Coordinate activities with central laboratories and other external service providers/vendors • Review and negotiate site budgets and contracts • Initiate and participate in the development of change orders to sponsor and/or site contracts and budgets • Maintain appropriate and effective communication with sponsor, external service providers, and other internal departments to ensure successful project completion

• Deliver comprehensive data management services across all study phases • Independently own assigned data management studies and deliverables from startup through database lock, proactively identifying risks, resolving issues, communicating status, and escalating when appropriate • Ensure clinical databases are complete, accurate, and compliant with Sponsor and regulatory standards • Serve as primary Sponsor contact for data management activities • Lead data management communications and coordinate with internal and external teams to ensure timely delivery of study milestones and progress updates • Train site staff (CRCs, CRAs, PIs) and client teams on EDC systems • Oversee CRF lifecycle from design to final delivery • Conduct User Acceptance Testing (UAT) and ensure database setup aligns with specifications • Develop and manage essential study documents (e.g., Data Management Plan, CRF Completion Guidelines, Validation Plans, SAE Reconciliation Plans) • Review and clean clinical data, manage queries, and reconcile third-party data • Coordinate database lock and final data delivery • Identify risks and proactively resolve project issues • Provide exceptional service to internal and external stakeholders

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. We are looking for a full-time Pharmacokinetic Scientist to join our Clinical Pharmacology team. This role will be remote but linked to our Belfast, Northern Ireland site. The successful candidate must have full, permanent right to work in the UK. The Pharmacokinetic Scientist will assist with pharmacokinetic data analysis, scientific interpretation of study results, clinical report writing, and interactions with clients. Essential Functions - Data analysis and interpretation - Perform PK analyses independently - Assist with PD analyses - Interpret PK and statistical results and findings independently - Perform QC reviews as assigned - Write and review reports as assigned - Prepare PK data/report files for electronic filing of projects for submission to regulatory agencies - Maintain and file all supportive documentation pertaining to the study and ensure proper archiving of projects - Other responsibilities - Interact with clients alongside or under direction of a senior scientist, as needed - Prepare internal presentations Requirements - Master’s or PhD degree in a biology-focused sciences related field with 2+ years of related experience required - Competence in performing noncompartmental pharmacokinetic analysis with software applications such as Phoenix WinNonlin - Familiarity with processes and applications related to non-linear mixed-effect modeling and/or physiologically-based pharmacokinetic modeling is an asset - Excellent oral and written skills (English language) required Celerion is an Equal Oppourtunies employer

Scientific Report Associate Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion offers one of the most experienced clinical pharmacology research networks in the industry. Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you! Celerion is searching for a full-time Scientific Report Associate for our Belfast, Northern Ireland location. This position will generate, template, and format preliminary and final clinical trial reports. This position will build appendices, import information from various sources and format the report per client specifications related to margins, fonts, table formats, hyperlinks, bookmarks and styles. An attractive salary and benefits package is available. This position will be a home-based role and candidates must be living in the UK and be eligible to work in the UK. Criteria - A Bachelor's degree OR 1 year relevant experience preferred. - Strong proficiency with MS Word and good Business English skills are essential. - The ability to manage multiple priorities and high attention to detail is required. Celerion is an equal opportunities employer.