Senior Project Manager OranSenior Project ManagerDistrict of ColumbiaThe ideal candidate will have strong project management experience and a background working with clinical data, healthcare, life sciences, regulatory environments, or related technology programs. Oran Inc. is seeking an experienced and motivated Senior Project Manager to lead and coordinate complex data, technology, healthcare, and regulatory-focused initiatives.
Associate Project Leader - Vaccines & Infectious Diseases Emmes GroupAssociate Project Leader - Vaccines & Infectious DiseasesRockvilleRemoteFull timeResponsibilities: Accountable for day-to-day execution of government research projects through collaboration with assigned projects' Emmes' project PI/Coordinating Center leader(s) and staff from other departments, including but not limited to Clinical Operations, Biostatistics, Clinical Data Management, Clinical Data Systems, Program Management, IT, Web Development, Finance, Contracts, Regulatory and Pharmacovigilance. Liaises with Emmes' project PI/Coordinating Center leaders, corporate leaders and other Emmes departments to ensure staff resources are continuously informed, trained and efficiently utilized within the project team to successfully execute the project scope.
Senior Manager, Field Medical Affairs-Neurology (mid-Atlantic states) Regeneron Pharmaceuticals IncSenior Manager, Field Medical Affairs-Neurology (mid-Atlantic states)Baltimore, MD$150,500–$245,500 / yearSupport clinical research activities throughout the life cycle (phase 1-4), as well as Investigator Initiated Studies, focusing on identification of pre-clinical, clinical and post-marketing study investigators/ experts and sites in alignment with Medical Affairs objectives. To be considered a Clinical/Science doctorate Degree required (MD, PharmD, PhD, DNP, DVM) along with a minimum of 3-5 years related work experience preferred (clinical, managed care, or industry experience) including experience as a Medical Science Liaison.
SENIOR MANAGER OF RESEARCH-DC COHORT Whitman-Walker HealthSENIOR MANAGER OF RESEARCH-DC COHORTWashington, DCIn this role, the Manager of Research-DC Cohort provides direct oversight of the DC Cohort protocol, subject recruitment, data collection and resolution of data queries, as well as, quality assurance, and regulatory operations for research studies and protocols; and ensures the ongoing cost-effective, compliant, ethical, and methodologically sound implementation of all research activities. Oversees a cost-effective, well-functioning, and well-supported project staffing model, ensuring the successful management of dedicated project staff for research protocols by ensuring continuity, appropriate coverage, task distribution, and overall needs.
NewResearch Scientist (HQ) - TBICOE The Henry M Jackson Foundation for the Advancement of Military Medicine IncResearch Scientist (HQ) - TBICOESilver Spring, MDTBICoE's mission to support the warfighter is executed through subject matter experts embedded across DHA facilities with expertise in TBI clinical research investigations, surveillance, clinical tool development and training, cognitive monitoring and assessment, and dissemination of TBI tools, products, and education/training materials to DoD medical personnel, service members, including Guard, Reserve, and operational medics/corpsmen, veterans with TBI, and families/caregivers of the warfighter. Assists in the development, implementation and maintenance of partnerships with patients, health care providers, researchers, family members, line leaders, community groups/resources, and stakeholders relevant to the prevention, care, and rehabilitation of TBI, brain health, blast effects, and/or cognitive monitoring as applicable.
NewDeputy Program Manager - TBICOE The Henry M Jackson Foundation for the Advancement of Military Medicine IncDeputy Program Manager - TBICOESilver Spring, MDTBICoE's mission to support the warfighter is executed through subject matter experts embedded across DHA facilities with expertise in TBI clinical research investigations, surveillance, clinical tool development and training, cognitive monitoring and assessment, and dissemination of TBI tools, products, and education/training materials to DoD medical personnel, service members, including Guard, Reserve, and operational medics/corpsmen, veterans with TBI, and families/caregivers of the warfighter. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.
Program Manager - TBICOE The Henry M Jackson Foundation for the Advancement of Military Medicine IncProgram Manager - TBICOESilver Spring, MDTBICoE's mission to support the warfighter is executed through subject matter experts embedded across DHA facilities with expertise in TBI clinical research investigations, surveillance, clinical tool development and training, cognitive monitoring and assessment, and dissemination of TBI tools, products, and education/training materials to DoD medical personnel, service members, including Guard, Reserve, and operational medics/corpsmen, veterans with TBI, and families/caregivers of the warfighter. Demonstrated expertise in providing guidance and direction to small and complex projects and programs; proven abilities in process development for organizationally critical processes, process improvement, change management; demonstrated capability in managing multi-task projects and programs of high complexity; broad responsibility in process design, implementation, and integration.
NewBrain Injury and Health Project Manager - TBICOE The Henry M Jackson Foundation for the Advancement of Military Medicine IncBrain Injury and Health Project Manager - TBICOESilver Spring, MDTBICoE's mission to support the warfighter is executed through subject matter experts embedded across DHA facilities with expertise in TBI clinical research investigations, surveillance, clinical tool development and training, cognitive monitoring and assessment, and dissemination of TBI tools, products, and education/training materials to DoD medical personnel, service members, including Guard, Reserve, and operational medics/corpsmen, veterans with TBI, and families/caregivers of the warfighter. Project Management Planning for brain injury, warfighter brain health, and related projects such as cognitive monitoring efforts: Acts as a subject matter expert in the planning and execution of a variety of projects related to WBHI, TAC, TBI/brain health space, and cognitive monitoring.
Project Manager II - Murtha Cancer Center The Henry M Jackson Foundation for the Advancement of Military Medicine IncProject Manager II - Murtha Cancer CenterBethesda, MDFacilitate the coordination of multidisciplinary efforts regarding quality management and regulatory readiness including coordinating protocol-specific training for study site staff and investigators, maintaining training logs and regulatory requirements. Collaborate with investigators and Clinical Research Coordinators (CRC) in the development of workflows, SOPs, research protocols and preparation of regulatory submissions to Institutional Review Boards (IRB) at the MTF level and National Cancer Institute Central IRB.
Federal Account Manager - MD/VA NetScout Systems IncFederal Account Manager - MD/VAMaryland, MDMatch Any Sparrow Carson City Michigan Athletic Club Michigan Athletic Club Restaurant Physicians Health Plan Sparrow Clinical Research Institute Sparrow Clinton Hospital Sparrow Eaton Hospital Sparrow Home Care Sparrow Hospital Sparrow Hospital Executive Sparrow Ionia Hospital Sparrow Medical Group Sparrow Medical Supply Sparrow Pharmacy Plus Sparrow Specialty Hospital Thoracic Cardiovascular Institute. Any Administrative/Clerical Clinical Professional/Technical/Allied Health Information Technology Internships Management/Professional Patient Services/Nursing Support Physicians & Advanced Practice Providers Radiology/Imaging Registered Nurses/Nursing Leadership Service/Support/Skilled Maintenance.
Senior Manager, Medical/Regulatory Writer Immunocore Holdings PlcSenior Manager, Medical/Regulatory WriterGaithersburg, MDVacancy NameSenior Manager, Medical/Regulatory Writer Vacancy NoVN831 Employment TypeFull Time Location of roleGaithersburg, MD, Radnor, PA, Remote, US DepartmentRegulatory Affairs Key ResponsibilitiesThe Senior Manager, Medical/Regulatory Writer will be accountable for leading and overseeing the medical and scientific regulatory writing for assigned programs to support submissions from first-in-human studies through product registration. Authoring or supervising the preparation of other regulatory documents required for Health Authority submissions, including but not limited to: Clinical Summaries (Clinical Overview, ISS/ISE, PK/PD summary, Advisory Committee Briefing document), Investigator Brochure(s), DSURs, other regulatory documents including briefing documents for health authorities, responses to Health Authority questions, etc.
Data Quality Analyst (Translational Research) Digital InfuzionData Quality Analyst (Translational Research)Rockville, MDWorking under the guidance of the Data Quality Manager and Scientific Program Manager, the Data Quality Analyst will review submissions for scientific and methodological soundness, support the development of efficient data workflows, and contribute to continuous improvements in data quality processes and models. This role requires attention to detail, familiarity with pre-clinical research concepts, and an interest in applying best practices to evolving areas of biomedical research, including influenza and infectious disease.
Sr. In-House CRA Emmes GroupSr. In-House CRARockvilleRemoteFull timeMay assist experienced CRA in the conduct of remote and/or on site monitoring visits such as qualification/pre study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for cause visits. Possesses working knowledge of the study protocol, site monitoring plan, and study manuals to triage questions or requests from site staff (e.g., enrollment updates, questions, missing documentation, meeting arrangements, etc.).
0.0 Westat0.0Bethesda, MDBasic Qualifications: Master's degree or equivalent education and years of experience in business, contracts, management, or a related field, with at least 15 years of experience in Federal Government contracting and contract management, including extensive leadership responsibility overseeing teams and a diverse portfolio of health-related federal contracts or equivalent experience. Experience negotiating and administering data-related agreements, including data licensing, data use agreements (DUAs), data transfer agreements (DTAs), research collaboration agreements, and partnerships involving healthcare claims, EHR, registry, and other research datasets.
Regulatory Document Coordinator and Training Manager AxleRegulatory Document Coordinator and Training ManagerBethesda, MarylandThe contractor staff shall coordinate document review activities and manage controlled access to current documentation, including: Coordination of cross-functional reviews involving relevant subject matter experts and stakeholders to ensure document accuracy. The contractor staff shall provide facility and building support services for the Division of Facilities Operations and Maintenance (DFOM), Office of the Director (OD), by serving as the DFOM/APF/BSL Document Coordinator and Training Manager.
Clinical Intern KolmacClinical InternTowson, MarylandKolmac Integrated Behavioral Health and Concerted Care Group (CCG) is proud to partner with colleges and universities nationwide to offer hands-on internship opportunities at our outpatient treatment centers across five states/District of Columbia. Kolmac Outpatient Recovery and Concerted Care Group (CCG) have merged to provide addiction treatment and behavioral health treatment services for individuals, families, couples, and groups.
Clinical Research Financial Coordinator II - Cardiology Washington University in St LouisClinical Research Financial Coordinator II - CardiologyWashingtonWhen necessary, works with other departments to set up services for clinical trial patients procedures performed in accordance with the protocol and is responsible for establishing a workflow to ensure study plans are in place to assist the study coordinators in completing study procedures and to ensure that supporting departments’ charges for study service are appropriately captured and billed to the study. Provides oversight, and training for clinical research financial billing coordinators who perform a review of new protocols, protocol amendments and Investigators initiated concept studies to establish and negotiate budgets for clinical trials.
Clinical Research Coordinator Trinity HealthClinical Research CoordinatorSilver Spring, MD$27.75–$44 / hourHoly Cross Hospital, in Silver Spring, is one of the largest hospitals in Maryland, and Holy Cross Germantown Hospital is the first hospital in the nation built on a community college campus, enhanced by an educational partnership. Position Purpose: The Clinical Research Coordinator coordinates pharmaceutical company, National Cancer Institute (NCI), multisite and in-house protocol activities for the Cancer Program and principal investigators.
Sr. Clinical Research Associate Emmes GroupSr. Clinical Research AssociateRockvilleFull timeAs part of the site visits, independently conducts Informed Consent (ICF) review, source data verification/source document review, review for compliance with required reporting/tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy/Investigational Product (IP)/Investigational Device (ID) storage location tour and storage condition assessment, IP/ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead. Responsibilities: Under minimal supervision of the project CRA staff oversight lead (i.e. Clinical Study Manager, Lead CRA, Project Manager, etc.) independently schedules and conducts remote and on site monitoring visits such as qualification/pre study visits, site initiation visits, interim/routine monitoring visits, closeout visits, and for cause visits.
Clinical Research Associate II- Government Sector Emmes GroupClinical Research Associate II- Government SectorRockvilleRemoteFull timeAs part of the site visits, independently conducts Informed Consent ICF review, source data verification source document review, review for compliance with required reporting tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy Investigational Product IP Investigational Device ID storage location tour and storage condition assessment, IP ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead. Responsibilities: Under supervision of the project CRA staff oversight lead, example, Clinical Study Manager, Lead CRA, Project Manager, etc., independently schedules and conducts remote and on-site monitoring visits such as qualification pre study visits, site initiation visits, interim routine monitoring visits, closeout visits, and for cause visits.