• Implement, execute, and oversee clinical trials within a clinical program • Partner with Director of Clinical Operations to develop and manage clinical programs • Provide operational leadership for trial planning, execution, and data collection • Oversee day-to-day activities of Clinical Trial Operations and Clinical Data Management groups • Collaborate on annual budget planning and vendor management • Ensure clinical trials are inspection ready • Coordinate development and review of protocols/amendments and operational execution

Role Description We are GDIT. As one of the largest IT and mission services providers to the government, we own our opportunities to better enable healthcare organizations to identify theirs. You can make GDIT your place. You make it your own by turning obstacles into action. By owning your opportunity at GDIT, you’ll play an important role in providing the technologies and services that millions of healthcare professionals depend on every day. Our work depends on a Technology Consulting SME joining our team to support our software development and support contract. This is a REMOTE BASED, PART-TIME ROLE. Candidate must live in the US. At GDIT, we put our people first. As a Technology Consulting SME supporting Indian Health Services you will be trusted to work with clinicians, developers, and federal staff to document changes and requirements for clinical applications. How You will Make an Impact: - Experience with immunization forecasting functionality, performing specialized comparative testing of the Immunization Calculation Engine (ICE) Forecaster in testing environments. - Plans, leads, and documents Immunization Office Hours, delivering technical briefings, system demonstrations, and guidance on system behavior and workflow impacts to health system users. - Has experience serving as a member of H5N1 (or similar) workgroups, supporting national preparedness and response efforts by establishing and enhancing health systems, processes, and infrastructure to enable automated, timely, and efficient disease case identification, surveillance, and reporting. - Maintains current knowledge of relevant technology and best practices relevant to the health industry and immunization. - Recognized for strong expertise in health industry and immunization issues and trends. - Utilizes functional area expertise gained through direct health industry experience to assess the operational and functional baseline of an organization and its organizational components. - Works with senior managers and executives to provide health industry and immunization vision and strategic direction with regard to their enterprise. - Guides the determination of information technology inadequacies and/or deficiencies that affect the functional area’s ability to support/meet organizational goals. - Generates functional area strategies for enhanced IT solutions in a cross-functional area mode throughout the organization. - Participates in program strategy sessions, strategic assessments, and design reviews to validate enterprise approach and associated work products, such as immunization solution implementations. - Provides guidance and direction to other professionals, acts in a consulting and/or advisory capacity; coordinates resolution of highly complex problems and tasks, possesses ability to meet and operate under deadlines. - Participates in special projects as required. - Opportunity to work from home with a geographically dispersed team. - Occasional travel may be required. - Must reside in the U.S. Qualifications - Doctorate’s Degree in computer science/systems, information systems/technology, engineering/engineering technology, software engineering/programming, management, natural and medical sciences, social sciences, mathematics, or business/finance. - Ten years of general IT experience and formal training and three years experience in BPR methods, plus training and one year experience in enterprise applications. - Experience with immunization forecasting functionality, specifically the Immunization Calculation Engine (ICE) Forecaster. - Experience with Health IT, EHR systems, and Meaningful Use. - Demonstrated ability to explain clinical/immunization issues clearly/accurately to technical/non-technical audiences. - Demonstrated ability to work in a collaborative team with adjusting priorities and deadlines. - Proven ability to work on a remote/distributed team. Requirements - 25+ years hands-on experience as a pharmacist. PharmD degree preferred. - Experience with the Indian Health Service RPMS and/or Veterans Administration VistA EHR systems. - Knowledge of the VA and IHS environments, RPMS or legacy VISTA. Benefits - Full-flex work week to own your priorities at work and at home, with core work hours Monday – Friday 9:00 AM ET – 3:00 PM ET. - 401K with company match. - Comprehensive health and wellness packages. - Internal mobility team dedicated to helping you own your career. - Professional growth opportunities including paid education and certifications. - Cutting-edge technology you can learn from. - Rest and recharge with paid vacation and holidays. - Challenging work that makes a real impact on the world around you. - Remote work.

Role Description The Regional Chief Medical Officer (RCMO) is responsible for the overall clinical integrity of the cardiology and other medical programs VitalSolution provides to hospitals assigned to the RCMO, in addition to their duties working as a full-time physician for VitalSolution. This position is directly responsible for the physicians in terms of their clinical expertise as well as their efficacy in patient care. This position is responsible for developing and implementing medical procedures and standards and updating those as the health care industry evolves. The RCMO will collaborate with the assigned Director of Clinical Operations (DCO) to perform these duties as needed. Responsibilities - Maintains a professional working relationship with all VitalSolution physicians providing services to Facilities. - Reviews and enforces VitalSolution physicians’ compliance with medical and clinical standards. - Manages and facilitates VitalSolution physicians’ compliance with operational and administrative policies, including time and expense reporting. - Acts as a liaison between VitalSolution physicians and facility management. - Leads and documents findings of quality review catheterization conferences with VitalSolution contracted physicians. - Manages and facilitates resolution among VitalSolution physicians to projected gaps in physician coverage. - Manages and facilitates VitalSolution physicians’ compliance with licensure and credentialing processes and document completion. - Reviews candidate Curriculum Vitae and clinical history and approves candidate for further evaluation. - Conducts reference check calls. - Conducts initial phone screen evaluations. - Participates in on-site candidate interviews. - Participates in candidate-Facility site visit introductions. - Participates in the physician new-hire onboarding process. - Actively identifies potential physician candidates and refers them to the VitalSolution recruiting team. - Maintains a professional working relationship with Facility executive leadership. - Maintains a professional working relationship with Facility clinical management and leadership. - Provides clinical consulting and recommendations to Facility management and leadership as needed to direct program improvements and initiatives. - Collaborates with Directors of Clinical Operations (s) to provide clinical content for Facility deliverables. - Collaborates with Directors of Clinical Operations (s) to present annual and periodic program reviews and assessments. - Collaborates with Business Development Manager(s) to participate in initial and any needed follow-up sales presentations and meetings to prospective Facilities. - Conducts on-site assessment of prospective Facility to determine: - Current state clinical and operational capabilities. - Current state medical culture of Facility’s medical staff. - Actively seeks and encourages testimonials from VitalSolution physicians for marketing initiatives. - Actively identifies patient and Facility testimonials for marketing initiatives. - Performs additional duties as requested by management. - Light Travel. Qualifications - Work as a physician for VitalSolution in a full-time capacity. - Medical degree, either a M.D. or a D.O. - Published in peer-reviewed journals preferred. - Advanced degree in management, such as M.B.A., M.P.H. or M.H.A. preferred. - ABIM Board certified in Cardiovascular Disease and Interventional Cardiology. - Three (3) years of experience in an administrative position. - Five (5) years of experience working in a team environment and three (3) years of experience in a supervisory position managing direct reports. Physical Demands and Work Environment - Ability to use sensory skills to effectively communicate and interact with other employees and the public through use of the telephone, email, video conference and face-to-face contact. - Ability to use manual dexterity, visual acuity and hearing acuity to effectively use and operate office-related equipment such as but not limited to a computer, copier, scanner, camera, phone, headset, keyboard and mouse. - Ability to sit for extended periods of time at a keyboard and workstation with low periods of reaching and standing. - Ability to lift up to 15 pounds at times. Benefits - Health, dental, vision. - FSA/HSA. - Company-paid life insurance. - 401K with discretionary match. - Paid time off. - Paid parental leave. - Tuition reimbursement.

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.