Project Manager
CAMRIS

Job Info

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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

• Obtain purified bulk vaccine candidates/biotherapeutics or bioreagents from the VPP downstream group.
• Verify all label information on the bulk from downstream is correct.
• Determine the aliquoting plan for each lot of bulk received per direction of the scientific operations manager for VPP.
• Generate the correct number of labels per container size for each lot.
• Perform the aseptic aliquoting for each lot of bulk in a biological safety cabinet.
• Determine the storage location for each aliquoted lot (-80C, -30C, or 4C) as specified by either the scientific operations manager or the project manager for the VPP.
• Liaise with VPP, VRC and external stakeholder personnel on receipt and distribution of above materials, including communication and documentation systems.
• Verify VPP produced materials are properly entered into the materials database.
• Maintain real-time inventory records, including storage conditions and location of above materials.
• Ship and receive above materials, including preparing shipments for postal or commercial conveyance; selecting appropriate shipping container; packing items to ensure safe delivery; preparing bills of lading; checking items to be shipped against work orders to ascertain that quantities, destination, and routing are correct.
• Liaise with VPP, VRC and external stakeholder personnel on receipt and distribution of above materials, including communication and documentation systems.
• Verify VPP produced materials are properly entered into the cell bank database.
• Maintain real-time inventory records, including storage conditions and location of above materials.
• Ship and receive above materials, including preparing shipments for postal or commercial conveyance; selecting appropriate shipping container; packing items to ensure safe delivery; preparing bills of lading; checking items to be shipped against work orders to ascertain that quantities, destination, and routing are correct.
• Maintain the 9WW waste room in accordance with MOCO, MDE, and Federal guidance.
  • Remain current with all changes in hazardous communications and regulations in accordance with shipping, handling and removal of biological and chemical compounds.
  • Follow and stay current on all IATA/USDOT/ and RCRA guidance for shipment of biological and chemical materials.
• Manage and provide oversight for scientific and regulatory-supporting documentation systems for a diverse group of 100+ scientists and administrative staff.
• Oversee general documentation systems and policies.
• Ensure, via policy development and liaising with VPP management and staff, that all documents meet pharmaceutical industry equivalent writing standards.
  • Design and provide training to VPP staff on current writing and grammar standards.
  • Provide grammatical and formatting review of technical documents and forms, as needed.
  • Identify documentation system gaps and work with VPP management to design and implement solutions.
  • Periodically review current VPP documentation system for areas of improvement.
• Manage and oversee the Electronic Document Management System(s) (EDMS), and SharePoint including, but not limited to: Serve as the main point of contact for EDMS document requests.
  • Serve as the EDMS Subject Matter Expert or SME, providing technical support to VPP staff.
  • Design and provide EDMS training to staff.
  • Ensure EDMS training records are adequately maintained.
  • Ensure all VPP documents are stored and managed in the EDMS system properly.
  • Support cross functional teams with creation, revision, approval or obsoletion of all documents processes within EDMS.
  • Track requests and progress through the EDMS review process and communicate with all affected stakeholders as needed.
  • Maintain EDMS standard work instructions (SOPs), training and reference materials.
  • Maintain document archives.
• Oversee the VPP storage and retrieval of laboratory notebooks.
• Oversee archiving of all job-related documentation (notebooks, training records, etc.). of departing personnel.
• Stay current on NIH and Federal documentation archival guidelines to ensure current and new documentation systems are in compliance.
• Develop and implement departmental policies related to primary duties and other aspects of VPP Scientific Operations as needed.
• Follow established departmental policies, procedures, and objectives, continuous quality improvement objectives, and safety, environmental, and/or infection control standards.
• Perform miscellaneous job-related duties as assigned including but not limited to performance of property checks, maintenance of service contracts on lab equipment and monitoring inventory levels.
• Serve as a primary or backup emergency responder for all VPP REES monitored equipment.
• Represent Scientific Operations group at safety meetings as needed.
• Operate dolly/ pallet jack in loading and unloading supplies and equipment.
• Maintain consumable inventory stock for VPP process.
• Perform inventory assessments/procurements, development of tracking systems, and equipment systems monitoring.

Qualifications

• Master's degree in scientific or medical field is required.
• Minimum of 4 years of biological materials handling experience, with emphasis on maintain sterility and preservation of biological materials.
• Minimum 6 years' experience managing scientific controlled document systems, in a scientific or clinical environment.
• Experience administering electronic controlled document systems.
• Thorough knowledge of document change control processes.
• Extensive experience in using computer software used for document management, formatting, editing, and archiving, including but not limited to, Microsoft Word and Adobe PDF creation, editing, and fillable form preparation.
• Thorough knowledge of professional grammar, writing, and editing practices.
• Knowledge of AMA or similar style guidance.
• Knowledge of general technical and/or scientific documentation classes and content requirements, such as standard operation procedures, investigative reports and other procedural documents.
• Experience with conversion of hard-copy records to electronic format.
• Individual must have excellent verbal and written communication skills (English).
• Individual must demonstrate the ability to communicate clearly and professionally.
• Demonstrated ability, per previous experience, to work independently.
• Proactive in the identification of organizational needs and/or problem areas within the scope of the position.
• Proactive problem solver.
• Highly skilled oral and written communicator:
  • Able to effectively present and communicate information to a diverse group of colleagues.
  • Able to address questions in a professional and constructive manner.
• Ability to apply professional experience and exercising good judgment in interpreting guidelines for specific situations and creativity in recommending new or modified procedures and products when needed.

CAMRIS International LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at www.CAMRIS.com . 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.

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