Senior IT Quality Validation Consultant job Woodcliff Lake New Jersey
Senior IT Quality Validation Consultant job Woodcliff Lake New Jersey
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Senior IT Quality Validation Consultant Job



Employer Name: SpiderID: 8817735
Location: Woodcliff Lake, New Jersey Date Posted: 7/18/2019
Wage: Negotiable Category: Medical/Health
Job Code: BBBH30038

Job Description:

Job Summary
Our Client, a human health care pharmaceutical company, is seeking a Senior IT Quality Validation Consultant to:



  • Provide Validation/QC guidance in regards to clinical data programming tasks for multiple studies.

  • Provide Validation/QC support for study team members from the study start up to the end.

  • Review/Provide Validation QC support for the database, data transfer, SDTM mapping specs to ensure that documents and specification are consistent and comply with internal/industry standards.

  • Perform data reconciliation, data quality control, and program SAS edit checks.

  • Review/generate/validate electronic submission deliverables such as SDTM datasets,

  • Perform Quality Testing/User Acceptance Testing of EDC systems.

  • Support quality control and quality audit of deliverables.

  • Contribute to activities for validation/QC and implementation including standard reporting systems, SAS macro utility programs and associated tools.


Responsibilities



  • Responsible for maintaining a formal quality control process in accordance with Clients standard operating procedures and Good Clinical Practice.

  • Perform validation & quality control to ensure all program development activities within the Oncology Business Group IODS follow established processes, and ensure proper documentation and timely posting into the TMF as required. This includes but not limited to the validation and QC support of clinical database design, reports & listings programs, SDTM conversion and related programming, post production changes, and implementation of programming tools within the IODS group


Essential Function



  • Work closely with the data management team members to coordinate and execute validation and QC activities

  • Evaluate system/study level validation/QC activities along with drafting of supporting documentation

  • Oversee testing and validation/QC activities of existing clinical studies

  • Collaborate with Regulatory and Publishing for submission activities


Qualifications



  • Bachelor or higher degree in Computer Science, Engineering or related field

  • Minimum 5 years' experience in the areas of software development life cycle supporting a GCP environment, clinical database set up in the pharmaceutical or related industries, clinical data management process and a practical understanding of GCP validation requirements

  • Aware of FDA, EMA, MHRA and ICH regulations and guidelines governing the conduct of clinical trails

  • Understanding of EDC systems, such as Medidata Rave, Inform, OC-RDC, IXRS (IRT), or other similar applications


Skills



  • Excellent oral and written communication skills; good people skills, good organizational skills to effectively guide multiple resources involved in various projects.

  • Excellent team player; able to work under pressure, handle situation involving different functions and teams




Please submit your resume for consideration. Once submitted, feel free to contact Caitie at 646-15-8355 for additional information.

Approx. Duration: 12 months

About Hired By Matrix

Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.

Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
Equal Opportunity Employer
WBENC Certified
WOSB Certified
*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.

We work hard to match our candidates with the right career opportunities. Let us find you a #MatrixMatch so you can reach your career goals!

Connect with us on LinkedIn and see how we can impact your career!

Hired by Matrix Career Center: https://www.hiredbymatrix.com/find-work/open-positions/



Job Criteria:
Start Date:
Position Type: Contractor
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:


Contact Information:
Contact Name: Hired by Matrix, Inc. Company Type:
Company: Hired by Matrix, Inc.
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