Scientific Program Manager - NIH - DAIT/CROP
Camris International

Job Info

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Overview

CAMRIS is a clinical and life sciences firm that realizes innovative solutions to challenges worldwide through high-quality, cost-effective program and research management services. We combine our proven systems with today's most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.

CAMRIS attracts the next generation of scientists to work at premier government research and development institutions with state-of-the-art facilities and equipment, under world leaders in health research. Our exceptional benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, and life insurance. If you enjoy being a part of a high performing health and research organization dedicated to making the world a healthier place, please apply today!

We are seeking a Scientific Program Manager to support the overall operational objectives of the National Institute of Allergy and Infectious Diseases. The primary objective is to provide clinical data management expertise through performance of clinical data management activities under direct supervision of DAIT/NIAID of the Clinical Research Operations Director at the National Institutes of Health (NIH).

Responsibilities

• Act as subject matter expert (SME) for all data management activities including proper data
  entry and tracking, human subject's protection, data confidentiality and related IT security.
• Develop and maintain a proficiency in accessing and reviewing clinical study related information
  from databases used by DAIT and/or NIAID and additional relevant clinical data databases
  including those of DAIT's clinical research organization (CRO) awardees, ImmPORT and
  ClinicalTrials.gov .
• Provide expertise to sponsor clinical data management projects on multiple complex studies and
  programs, both internal and performed by supporting clinical research organizations (CROs).
• Provide technical oversight of CROs performing core data management functions including case
  report form (CRF)/edit check development, user acceptance testing, data cleaning, listings
  review, and database lock procedures.
• Responsible for the oversight of clinical data management study deliverables, evaluating and
  mitigating data management risks.
• Provide expertise to assist in CRF and database design.
• Assist in the development and implementation of data transfer and migration plans relating to
  transitions between CROs.
• Perform or oversee development of clinical data management validation plans, data transfer
  requirements and agreements, and data management plans
• Provide expertise in support of developing sponsor data management SOPs, procedures, PWIs,
  Plans, Guidance and other quality-related documentation.
• Devise and oversee implementation of quality assessment procedures according to data
  management plans and other means.
• Assess the quality of the statistical programming processes through techniques including but not
  limited to good documentation code review, and testing.
• Assist with the creation and review of CAPAs related to clinical data management.
• Review and process clinical trial data to ensure data quality for data analysis.
• Participate in clinical study data reviews and other activities related to database lock.
• Participate in multi-party clinical data process development initiatives.
• Assist in the development of data pathways and system interconnection arrangements.
• Provide input on clinical data management system enhancements including design, review,
  performing user acceptance testing and validation supporting activities.

Qualifications

• Master's degree in a related discipline required. A Ph.D. in a related discipline a plus.
• At least five (5) years of clinical data management experience is required.
• Excellent verbal and strong written communication skills are required as this person is
  expected to interact with team members from various disciplines every day.
• Excellent analytical, organizational and time management skills required.
• Thorough understanding and experience with GCP/GxP, Privacy Act and quality
  requirements are required.
• A working knowledge of clinical data management tools is required.
• Experience programming and using Medidata Rave, Oracle Argus and RedCap preferred.
• Familiarity with clinical trial data standards such as CDISC preferred.
• Experience in developing eCRFs and clinical databases required.
• Experience creating and evaluating clinical data management plans and agreements
  preferred.
• Experience working within a quality-driven environment is preferred.
• Experience creating and evaluating SOPs and CAPAs required.
• Systems validation experience preferred.
• Knowledge of data systems architecture and structure of data systems is required.
• Pharmaceutical industry experience a plus.
• Excellent computer skills, proficient in Microsoft Office, SQL and XML required.
• Experience with statistical software such as R, SAS, Stata, & SPS preferred.

CAMRIS International, LLC offers competitive salaries and comprehensive benefits. Please submit your resume online at 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, national origin, age, protected veteran status, disability status, or any other characteristic protected by any applicable federal, state, or local law.

Full vaccination against COVID-19, defined as two doses of Moderna, two doses of Pfizer, or one dose of Johnson & Johnson's Janssen, is required for this position.

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