Project Manager

3 weeks ago

Bethesda, Maryland, United States CAMRIS International, LLC Full time
Overview

We are seeking a Project Manager to support the National Institutes of Health's (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with groundbreaking research. Candidates will work at a prominent, diverse and vibrant NIAID worksite to directly support exciting ongoing research activities as a contractor team member. Accelerate your career and apply below to help us make a difference.

CAMRIS International is a dynamic clinical research and international development firm that achieves innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. We combine our proven systems with today's most effective, evidence-based best practices. Our core practice areas include: clinical research; vaccine research, microbiology and infectious disease research, development and production; biodefense; global health security; and HIV/AIDS programs.

Our employees enjoy a diverse, collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.

Responsibilities
  • Provide quality management support for Division clinical research activities.
  • Support the development, implementation, maintenance, and oversite of a clinical quality management system in NIAID - inclusive of document management, issue management, CAPA development, and quality assurance (QA) activities.
  • Advance the writing of documents as part of the quality management system (SOPs, policies, audit reports, etc.), by both actively leading the development of documents and facilitating working groups to collaborate and write documents.
  • Support the development and implementation of the Division's electronic Quality Management System (eQMS).
  • Stay current with changes to current industry standards and applicable regulations for quality in clinical research.
  • Lead the oversight and management of quality assurance including investigator site audits, internal audits, and clinical vendors/CROs audits with guidance from management. This includes the development and/or review of tools including audit agendas, audit plans, audit reports, and CAPA's for internal & external audits.
  • Participate in preparations for regulatory inspections, which may include reviewing inspection readiness plans, mock inspections, and risk-based management of program inspection quality events.
  • Assist in resolving compliance issues at clinical sites, clinical vendors, and contracted research facilities; and provide assessment of the impact of any deficiencies.
  • Review, track and/or trend routine quality data.
  • Report adverse trends to management with proposed remediation plan.
  • Coordinate the development of various QA related metric reports.
  • Work with other groups in DMID that are funding, overseeing, and implementing clinical research to understand how clinical research is supported by DMID.
  • Based on understanding of Division operations, look for ways to standardize processes to improve quality and/or facilitate efficiency.


Qualifications
  • Bachelor's degree in a related discipline.
  • Minimum of five (5) years of experience in clinical research or a related field.
  • Experience in establishing and managing quality management systems for clinical research for IND sponsors (e.g. in pharmaceutical companies, biotechnology companies, or government sponsors).
  • Working knowledge of the quality management cycle and corrective Action/Prevention Action (CAPA) processes.
  • Experience with US and international Good Clinical Practice (GCP), guidance documents, and industry best practice in all areas of a GxP environment.
  • Knowledge of electronic clinical quality management systems such as Master Control is preferred.
  • Experience in regulatory inspections from the US FDA or similar government regulatory authorities is preferred.
  • Experience conducting or overseeing audits is preferred.
  • Experience working at a clinical research site is preferred.
  • Experience in the NIH or other government agency is preferred.
  • Excellent communication skills both verbally and written; and across functions internally and externally.
  • Ability to organize, prioritize and deliver tasks & projects according to pre-defined deliverables.
  • Ability to effectively build and maintain relationships with multiple departments and external entities (e.g., Investigator sites, clinical Vendors/CROs) in order to effectively solve problems.
  • Excellent multi-tasking, analytical, organizational and teamwork skills.
  • Ability to troubleshoot, identify root cause and systematically resolve problems.
  • Ability to produce high-quality work on complex problems with cross-functional involvement.
  • Proficient in Window based software to include Excel, Word.

CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at . CAMRIS is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

Some positions or sites may require that the incumbent be fully vaccinated against COVID-19. Proof of vaccination may be required.

Employment is contingent upon successful completion of a Public Trust-level background check, a requirement for this position under an active federal contract. The background check process may include, but is not limited to the following: (1) contacting your professional references; (2) verification of previous employment, education and credentials; (3) a criminal background check; (4) use/abuse of federally-controlled substances; and (5) a department of motor vehicle check. Candidates must be prepared to fully-complete any required background check questionnaire during initial onboarding.

  • Project Manager

    5 days ago

    Bethesda, Maryland, United States Axle Inc Full time

    Job Description Job Description (ID:Axle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus...

  • Project Manager

    5 days ago

    Bethesda, Maryland, United States HelioCampus Full time

    Who We Are: Born out of higher education, HelioCampus works with institutions throughout North America to optimize financial decision-making and assessment/accreditation processes, and provide a more integrated approach to strategic planning and institutional effectiveness. HelioCampus is backed by professionals passionate about the impact of innovation on...

  • Project Manager

    2 months ago

    Bethesda, Maryland, United States Bethesda Marriott Full time

    Job Number Job Category Information TechnologyLocation Marriott International HQ, 7750 Wisconsin Avenue, Bethesda, Maryland, United States VIEW ON MAPSchedule Full-TimeLocated Remotely? NRelocation? NPosition Type Management Job SummaryDelivers projects on time, within budget, while meeting Marriott's expectations. Plans, directs and coordinates activities...

  • Project Manager

    3 weeks ago

    Bethesda, Maryland, United States CAMRIS Full time

    Overview We are seeking a Project Manager to potentially support the upcoming National Institutes on Deafness and Other Communication Disorders (NIDCD) Clinical Trials Program (CTP). NIDCD needs coordinating and operational services by specialized individuals who have knowledge and expertise in industry standard clinical trial protocol development, readiness...

  • Project Manager

    3 weeks ago

    Bethesda, Maryland, United States CAMRIS Full time

    Overview We are seeking a Project Manager to potentially support the upcoming National Institutes on Deafness and Other Communication Disorders (NIDCD) Clinical Trials Program (CTP). NIDCD needs coordinating and operational services by specialized individuals who have knowledge and expertise in industry standard clinical trial protocol development, readiness...

  • Project Manager

    5 days ago

    Bethesda, Maryland, United States BCC-NIH Full time

    Overview Black Canyon Consulting (BCC) is actively looking for Project Manager(s)/Agile Scrum Master to support our work for the National Institutes of Health. This opportunity is full time and onsite at the NIH in Bethesda, MD and/or remote work. We attract the best people in the business with our competitive benefits package that includes medical, dental...

  • Project Manager

    5 days ago

    Bethesda, Maryland, United States BCC-NIH Full time

    Overview Black Canyon Consulting (BCC) is actively looking for Project Manager(s)/Agile Scrum Master to support our work for the National Institutes of Health. This opportunity is full time and onsite at the NIH in Bethesda, MD and/or remote work. We attract the best people in the business with our competitive benefits package that includes medical, dental...

  • Project Manager

    5 days ago

    Bethesda, Maryland, United States GAP Solutions, Inc. Full time

    Provide services as a Project Manager in support of the overall functions of the Vaccine Research Center (VRC), Office of the Scientific Director (OSD) within the National Institute of Allergy and Infectious Diseases (NIAID).Duties and Responsibilities: Oversee 200,000 sq ft of administrative and laboratory space, including four buildings, both on and off...

  • Project Manager

    3 days ago

    Bethesda, Maryland, United States GAP Solutions Inc Full time

    Position Objective: Provide services as a Project Manager in support of the overall functions of the Division of Intramural Research (DIR), Office of the Director (OD) within the National Institute of Allergy and Infectious Diseases (NIAID). Duties and Responsibilities: Provide planning, implementing and evaluating laboratory programs and duties. Organize,...

  • Agile Project Manager

    5 days ago

    Bethesda, Maryland, United States Tantus Technologies Full time

    Overview In anticipation of an award, Tantus Technologies, Inc. (Tantus) - recognized by the Washington Post as a Top Workplace - is seeking an Agile Manager. You will lead and oversee support in the areas of planning, organizing, managing, coordinating, and tracking of multiple application development projects from planning to completion. This includes...

  • Senior Project Manager

    5 days ago

    Bethesda, Maryland, United States Marriott Full time

    Job Number Job Category Information TechnologyLocation Marriott International HQ, 7750 Wisconsin Avenue, Bethesda, Maryland, United StatesSchedule Full-TimeLocated Remotely? NRelocation? NPosition Type ManagementJOB SUMMARYThe Senior Project Manager is a key player in Marriott's Disaster Recovery Program, responsible for overseeing project delivery and...

  • Program/ Project Manager

    5 days ago

    Bethesda, Maryland, United States NetImpact Strategies Full time

    Job Description: NetImpact is looking for a Program/ Project Manager. In this role, you will deliver the services identified in the contract. The Program Manager will be the main Point of Contact (POC) for the services and deliverables provided under the contract. Program Manager will ensure cohesiveness between all Tiers, develop, execute process...

  • Program/ Project Manager

    5 days ago

    Bethesda, Maryland, United States NetImpact Strategies Full time

    Job Description:NetImpact is looking for a Program/ Project Manager. In this role, you will deliver the services identified in the contract. The Program Manager will be the main Point of Contact (POC) for the services and deliverables provided under the contract. Program Manager will ensure cohesiveness between all Tiers, develop, execute process...

  • Project Manager

    3 weeks ago

    Bethesda, Maryland, United States CAMRIS International, LLC Full time

    OverviewWe are seeking a Project Manager to support the National Institutes of Health's (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with...

  • Project Manager

    4 weeks ago

    Bethesda, Maryland, United States CAMRIS International, LLC Full time

    OverviewWe are seeking a Project Manager to support the National Institutes of Health's (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel are part of a preeminent team focused on positively impacting millions of lives around the world with...

  • Manager, Project Manager, New Builds

    5 days ago

    Bethesda, Maryland, United States Marriott Hotels & Resorts Full time

    Marriott International is seeking to hire an experienced Project Manager (with a design & construction focus) excited to travel to all parts of North America and partner with the most ambitious franchisees in the hospitality industry. As the newest P Manager, Project Manager, Project Management, Internal, Project, Hospitality, Hotel, Business Services

  • Senior Project Manager

    5 days ago

    Bethesda, Maryland, United States ZoomInfo Technologies, Inc. Full time

    Join our Team at ZoomInfo! Encouragement for creativity and innovation Teamwork and accountability are a must Emphasis on achieving results We appreciate individuals with a proactive and results-oriented attitude We are committed to helping you unleash your potential for growth Looking for aProject Manager role that involves Technical aspects, managing...

  • Principal Project Manager Lead

    5 days ago

    Bethesda, Maryland, United States Covalent Solutions Inc. Full time

    Job DescriptionJob DescriptionJOB SUMMARYCovalent Solutions (Covalent) is seeking a mission driven, highly motivated and collaborative Principal Project Manager Lead who is truly excited about building great products and user experiences to support the All of Us Research Program (AOU) at the National Institutes of Health (NIH). AOU was established to...

  • Senior Capital Project Manager

    3 weeks ago

    Bethesda, Maryland, United States B.F. Saul Company Hospitality Group Full time

    Are you looking for a great place to work? Our team in the Capital Assets Hospitality Group is seeking a new Senior Capital Project Manager. This professional project manager is responsible to support the capital improvement process for the Hospitality Group's hotel assets. This individual has a creative vision, entrepreneurial thinking, and a breadth of...

  • Senior Capital Project Manager

    4 weeks ago

    Bethesda, Maryland, United States B.F. Saul Company Hospitality Group Full time

    Are you looking for a great place to work? Our team in the Capital Assets Hospitality Group is seeking a new Senior Capital Project Manager. This professional project manager is responsible to support the capital improvement process for the Hospitality Group's hotel assets. This individual has a creative vision, entrepreneurial thinking, and a breadth of...