Clinical Trials IT Manager

Employer
Westat
Location
Rockville , MD
Posted
Aug 14, 2020
Closes
Sep 18, 2020
Function
IT, Management
Industry
Research
Hours
Full Time
Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.

Westat is seeking an IT Manager to support our growing Clinical Trials Practice (CTP), which encompasses the performance of domestic and international clinical trials and clinical research.  The ideal candidate must be familiar with federal regulatory requirements governing clinical trials, standards related to the use of IT systems, and products in the performance of clinical trials. Demonstrated strong, successful leadership skills and experience working in a clinical trials environment are required. 

The CTP IT Manager will:
  • Work with CTP senior leadership and project managers to determine project IT resource needs and supervise staff on CTP projects.
  • Lead and manage multiple teams of programmers and developers in software development and the configuration of SaaS and COTS tools, including those related to analytics, data visualizations, and emergent technologies.
  • Represent IT on the CTP Quality Board to ensure that all systems and processes are 21 CFR Part 11 compliant.
  • Ensure that all projects within the CTP are compliant with relevant security requirements, such as FISMA (or FEDRAMP), HIPAA, and Privacy Act. 
  • Participate in business development efforts and contribute to government and private industry proposals. 

The CTP IT Manager is expected to proactively maintain knowledge of IT trends, software, and systems related to clinical research, routinely identifying processes and new technologies to improve quality and scalability. 
 
Job Responsibilities:
  • Supervise  programming teams  in design and development, of clinical IT support to government and private industry projects, 
  • Manage task assignments and assist in technical planning, project budgeting, and developing IT solutions for business opportunites
  • Oversee the CTP Medidata Coordinator to ensure that all Medidata products are appropriately managed across CTP projects.
  • Routinely review and revise IT SOPs and ensure compliance 
  • Lead programming using SAS, R, Python, and other analytical tools. 


Basic Qualifications:
  • A Bachelor's degree in Computer Science or related field
  • At least 10 years of experience managing IT needs in the area of clinical research/clinical trials including a minimum of 5 years of experience with programming in support of study management, data collection, collaboration, and analysis (e.g. SAS for clinical trials, R, Python and open source technologies).
  • Sound understanding of security required by the Federal government (e.g. FISMA, Privacy Act, HIPPA).
  • Sound understanding of 21 CFR Part 11 compliance.
  • Knowledge of CDISC standards to be able to collaborate and contribute to the CTP's ongoing mission to ensure these are applied and understood across all regulated projects 


Preferred Qualifications:
  • Strong project management experience working on large, cross-functional projects with evolving requirements

 
Successful candidates will have an entrepreneurial spirit combined with strong architectural and problem-solving skills. Demonstrated leadership and collaboration skills are necessary in addition to proposal writing strength with the ability to offer innovative IT solutions. Excellent written, verbal, and visual communication skills, with the ability to influence at management level are key. 

Westat offers competitive benefits with ESOP, 401k, Health, Dental, paid vacation, sick and holiday leave, professional development as well as other benefits.

Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity or expression, or any other protected status under applicable law.

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