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Project Manager

11 hours ago

Bethesda, Maryland, United States CAMRIS 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 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 collegial environment where individual contributions matter at all levels. At CAMRIS, you will notably improve the lives of people at home and abroad.  

Responsibilities
  • Maintain LIMS systems; Monitor the system, ensure LIMS is operational at all times, assist with upgrades, write necessary SOPs for maintenance and preventative maintenance (with QA sign off).
  • Support senior VIP personnel to ensure systems are compliant at all times.
  • Manage data streams from study proposal, through all assay and general lab procedures, to analysis and reporting in compliance with data integrity best practices and FDA title 21 part 11.
  • Assist in the development of novel data housing structures and workflow specific for the requirement of the Vaccine Immunology Program.
  • Maintain data handing and chain of custody procedures for internal and external data transfer if not in place and monitor/improve existing procedures.
  • Manage data formatting input and output.
  • Write SOPs for data workflows and procedures, work with VIP QA personnel to validate.
  • Assist in the presentation data handling capabilities both internally or externally and work with prospective clients to implement new data streams.
  • Implement and maintain data processing scripts to transform data for upload and export to repositories and/or monitor/improve existing procedures.
  • Implement and maintain reports for various data management systems.
  • Develop and manage QC criteria and protocols in regard to data quality and standardization working with the VIP QA personnel.
  • Assist in the training of lab staff on data workflow and procedures as well as best practices for data handling and formatting.
  • Support lab management with data processing needs such as exclusions or all data sets for reporting.
  • Support statisticians with data processing needs to provide them with data in required structure for statistical analysis with a variety of tools (e.g., SAS).
  • Assist with new application interfacing such as Electronic Laboratory Notebook (ELN), maintenance and training, third party system integration etc.
  • Maintain, monitor and improve where necessary internal structures, permissions, and users as needed by lab staff working in conjunction with IT.
  • Respond to issues experienced by lab staff and work in conjunction with IT to resolve.
  • Work directly with clinical, laboratory, QA and IT staff on all aspects relating to the LIMS system if required.
  • Assist staff on LIMS systems use; Write SOPS for LIMS system use.
  • Handle ordering and create cost projections on LIMS systems installation and annual maintenance as established by the senior VIP personnel.
  • Provide IT technician specifications of installation and management vendor travel and training.
  • Work with QA and IT on performance testing and validation of systems.
  • Liaise with vendors on new systems and feature development.
  • Perform basic and continuing training for VIP LIMS.
  • Assist OCICB with any LIMS User Requirement Specifications testing as necessary for validations.
  • Perform data integrity checks and cross checks with VIP collaborators.
  • Generate and distribute inventory reports for the VIP biorepository.
  • Assist laboratories in uploading inventory to LIMs and/or ELN.
  • Additional duties as assigned.
Qualifications
  • Bachelor's degree in Information Technology, Computer Science or a related discipline.
  • Minimum of 3 years of experience in a computer related field.
  • Demonstrated experience with various computer systems and software packages.
  • Strong computer system expertise, from a super-user rather than an IT perspective.
  • Lab information management systems experience – LIMS desirable.
  • Demonstrate ability to multi-task and prioritize projects efficiently, as well as ability to work independently and proactively on various projects.
  • Ability to work in a high-pressure environment with defined deliverables.
  • Demonstrate attention to detail, with strong troubleshooting and problem-solving skill.
  • Knowledge of governing regulations for laboratory-based computer systems.
  • Excellent technical writing skills and good documentation practices with understanding of standard operating procedures.
  • Demonstrate ability to work in a team setting and to handle high-through put environment.
  • Ideally possess the ability to speak the language of laboratory, clinic, QA and IT personnel.
  • Strong oral and written communication skills both technical and interpersonal.

Physical Requirements:

The physical requirements described here are representative of those that must be met by a candidate to perform the essential functions of this job. Reasonable accommodations may be provided to enable individuals with disabilities to perform essential job functions.

  • Ability to lift or carry less than 25 pounds, push or pull less than 25 pounds, push or pull 25 – 45 pounds, and push or pull more than 45 pounds.
  • Ability to work closely with others.
  • Will be required to be in contact with human blood or other body fluids.
  • Must be able to wear personal protective equipment (PPE), including gloves, face shields/goggles, safety glasses, and lab coat.

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.

CAMRIS offers a comprehensive benefits package, including medical, dental, and vision insurance for individuals and families, FSAs, HSA, life and AD&D insurance, short- and long-term disability, legal services, voluntary hospital indemnity, critical illness and accident insurances, EAP, pet insurance, 401(k) with employer match and Roth option, tuition and professional reimbursement, public transportation support in the DMV area, a referral bonus program, vacation with tenure-based increases, PTO, 11 paid holidays, paid bonding leave, and paid supplemental short-term disability.

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.