April 16, 2026For U.S. Positions: While subject to change based on business needs, Leidos reasonably anticipates that this job requisition will remain open for at least 3 days with an anticipated close date of no earlier than 3 days after the original posting date as listed above.
Bachelor’s degree in Computer Science, Data Science, Engineering, Information Systems, or related technical discipline and 8–12 years of relevant experience OR Master’s degree in a related field and 6–10 years of relevant experience.
Keywords: Clinical Research, Clinical Trials, Clinical Operations, In-House CRA, TMF, Trial Master File, eTMF, Veeva Vault, Regulatory Documents, Regulatory Affairs, Document Management, ICH GCP, FDA Regulations, Good Clinical Practice, Essential Documents, Site Document Collection, IRB Submissions, OHRP Regulations, Site Start-Up, Study Coordination, Clinical Study Support, Monitoring Support, TMF Maintenance, Document Tracking, Compliance, Audit Readiness, Clinical Data Management, Sponsor Oversight, CRO, Protocol Compliance, Investigator Communication, Site Management, Clinical Systems, Database Tracking, Microsoft Excel, Microsoft Word, Microsoft Outlook. Responsibilities of the In-House Clinical Research Associate include: Review and process essential regulatory documents received from clinical trial sites.
Rockville, MD30+ days ago
Reporting directly to the Vice President of Operations, Client Delivery Services, the Project Director collaborates with Practice Area Leads, Technical Operations leadership, and cross-functional teams to ensure excellence in execution, financial performance, and client satisfaction while driving innovation across the health-research ecosystem. This role provides scientific, operational, and programmatic leadership for a multidisciplinary team delivering comprehensive project management, regulatory oversight, data and safety monitoring coordination, analytics, and recruitment support for Alzheimer’s disease and aging-related studies.
Silver Spring, MD21 days ago
The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university.
Gaithersburg, MD30+ days ago
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. You will also be assigned to a project and are leading a team of clinical scientists and will be an important part of the project Team, working collaboratively with the program and study level physician or clinical lead as their guide in medical scientific aspects of the compound and its development.
We are seeking applications from aspiring clinical researchers (and clinicians) who are committed to cutting-edge work using community-based, neurodiversity affirming, qualitative, and neuroimaging (EEG/ERP, fMRI) methods to improve quality of life for autistic people. Independently coordinates, conducts and documents visits and protocol-specific testing/interviews according to study protocol, operational plans of clinical departments and SOPs for minimal risk studies or for other studies under direction.
li>Assists the providers and the Care Coordination Team to manage the care of patients according to their risk, and to assist in identifying patients in need of Case Management. Ensures the required documentation of quality control inspections are completed, which may include documentation of temperature readings, expiration date assessment, and the maintenance of emergency supplies and equipment.
li>Assists the providers and the Care Coordination Team to manage the care of patients according to their risk, and to assist in identifying patients in need of Case Management. Ensures the required documentation of quality control inspections are completed, which may include documentation of temperature readings, expiration date assessment, and the maintenance of emergency supplies and equipment.
Leesburg, Virginia18 days ago
div class="job__description body">The Clinical Supervisor is a Board Certified Behavior Analyst (BCBA) who serves as a key clinical leader in the clinic, directly supporting clinical operations and providing clinical oversight for all clinicians.
- Maintain a caseload of clients, conducting assessments, developing behavior intervention plans (BIPs), and updating treatment plans based on client progress and needs.
Gaithersburg, MD30+ days ago
The team strives to deliver compelling preclinical, clinical and translational data packages providing confidence in the dosing strategy, tolerability profile and therapeutic efficacy of our candidate drugs to support investment in late-stage clinical development, leading to drug approval. Lead clinical aspects of projects from preclinical Lead Optimization Investment Decision to clinical Proof of Concept (PoC):
Responsible for all clinical aspects of project strategy including translational, clinical development, patient selection, regulatory, pediatric, and Asian development strategy.
Bethesda, Maryland30+ days ago
Reporting to the SVP Clinical Strategy & Product, this role partners closely with clinical leadership, analytics, product, and client-facing teams to ensure clinical initiatives are effective, measurable, and aligned with client goals. This individual will translate clinical and pharmacy data into meaningful insights, support client deliverables, and contribute to continuous improvement of LucyRx’s clinical programs across commercial and government populations. .
Frederick, MD30+ days ago
These valued members of our clinical performance team leverage advanced data analytics to identify opportunity to partner closely with hospital leadership care team and our Sound clinical leaders to enhance care coordination and support continued improvement to patient quality and outcomes. You play a critical role in aligning teams reinforcing best practices and helping drive improvements in quality documentation throughput and communication - all while fostering strong relationships with clinicians and hospital partners.
Gaithersburg, MD30+ days ago
p>As a Senior Manager, Statistical Programming at BioNTech, you will be instrumental in ensuring high-quality statistical programming deliverables that support our clinical development projects. Your benefits and remuneration:
Expected Pay Range: $130,800/year to $198,200/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).
li>Conduct medical reviews of Individual Case Safety Reports (ICSRs), including Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Adverse Drug Reactions (ADRs), causality assessments, signal detection, case narratives, aggregate reports, and safety data listings, and communicate all applicable comments to the Pharmacovigilance Lead. Conduct medical reviews of clinical trial documents including clinical trial protocols, informed consent forms, Investigator's Brochure and other essential study documents and plans, and provide input to Clinical Development, Medical Writing, and Clinical Operations teams.
Gaithersburg, Virginia30+ days ago
April 16, 2026For U.S. Positions: While subject to change based on business needs, Leidos reasonably anticipates that this job requisition will remain open for at least 3 days with an anticipated close date of no earlier than 3 days after the original posting date as listed above. Leidos Digital Modernization sector is seeking an experienced Senior Data Architect Lead to support the delivery, enhancement, and adoption of enterprise data and analytics products used across multiple DoD organizations.
Silver Spring, MD30+ days ago
The Senior Solutions Architect - Patient Room & Clinical Technology leads the design of next-generation patient care environments by integrating clinical systems, connected devices, and digital patient engagement platforms. Aid architects to validate and fix information management issues related to data quality framework (completeness, accuracy, availability, timeliness, consistency, etc.).
Rockville, MD30+ days ago
Author clinical trial documents including but not limited to protocols, charters, safety monitoring plans, IND reports, process documents, meeting presentations, publications, and clinical sections of regulatory documents such as INDs, briefing books, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals. The incumbent is also responsible for all medical third-party vendors; serves as subject matter expert and performs other tasks including but not limited to oversight of drug safety, addressing complex medical issues related to safety, and acts as author/developer of clinical summary and other supporting documents for regulatory submissions and for publications.
p class="MsoNormal">The Clinical Agreement Manager (CAM) is a trained clinical healthcare or management analyst who has customer service experience provider who serves as FOH health services Subject Matter Expert (SME) and trouble shooter for the implementation and ongoing provision of services to FOH agency customers. • Communicates and collaborates directly with RCMs/ACMs to ensure clinics are equipped with adequate numbers of staff members with required security clearances for assigned customers in response to new requests for services, or increases to existing services.
table style="margin:0px;padding:0px;border-collapse:collapse;width:auto;color:#000000;font-family:'roboto' , 'helvetica neue' , 'helvetica' , 'arial' , sans-serif;font-size:12px;font-weight:400;border:none">- Flexible Approved Time Off. Responsibilities:
- Accountable for technical, scientific, and fiscal execution of government research projects through collaboration with staff from multiple departments, including Clinical Operations, Biostatistics, Clinical Data Management, Clinical Data Systems, Program Management, IT, Web Development, Finance, Contracts, Regulatory, and Pharmacovigilance.
table style="margin:0px;padding:0px;border-collapse:collapse;width:auto;color:#000000;font-family:'roboto' , 'helvetica neue' , 'helvetica' , 'arial' , sans-serif;font-size:12px;font-weight:400;border:none">- Flexible Approved Time Off. Responsibilities:
- 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.
The Research Nurse Specialist will function within a team of clinical providers and research support staff to support the coordination and execution of NHLBI's research protocols and clinical trials within the specialty areas of hematology-oncology, cardiology, pulmonary, sickle cell disease, vascular medicine, and cellular therapy. What You Will Do: We are currently searching for a skilled Registered Nurse with clinical research experience to fill a Research Nurse Specialist position that will meet the overall operational objectives of the National Heart, Lung, and Blood Institute (NHLBI) through the provision of research support services. Gaithersburg, MD30+ days ago ul>- Strategic Leadership - Define and execute the vision for Evinovas customer implementation practice, establishing the operating model, methodology, and organizational structure to deploy established rapidly evolving sponsor-facing AI products (Study Designer, Study Document Assistant, and AI Document Authoring) across a portfolio of top-tier pharma and CRO customers. The Evinova AI Product Implementation Leader is responsible for building and leading the Professional Services organization that deploys Evinovas AI-native clinical trial platform - including its Study Designer, Study Document Assistant, and AI Document Authoring products - across a portfolio of the worlds largest pharmaceutical companies and CROs.
Bethesda, Maryland20 days ago The Research Nurse Specialist will function within a team of clinical providers and research support staff to support the coordination and execution of NHLBI’s research protocols and clinical trials within the specialty areas of hematology-oncology, cardiology, pulmonary, sickle cell disease, vascular medicine, and cellular therapy. We are currently searching for a skilled Registered Nurse with clinical research experience to fill a Research Nurse Specialist position that will meet the overall operational objectives of the National Heart, Lung, and Blood Institute (NHLBI) through the provision of research support services. Keywords: Central Monitoring, Risk-Based Quality Management, Clinical Trials, ICH GCP, KRIs, QTLs, Clinical Risk Management, CRO, CRA, Data Analysis, FDA Regulations, Oncology, Infectious Disease, Clinical Research, Remote, Bethesda MD. Excellent facilitation, presentation, and problem-solving skills; strong written and verbal communication; attention to detail and quality control; and experience with clinical research systems and tools.
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