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Safety Monitoring Programmer - Woodcliff Lake, New Jersey

Job Location: NJ - Florham Park

Regional Description: Northeast

Job Number: 00536257


- Job description

Join Accenture and help transform leading organizations and communities around the world.  The sheer scale of our capabilities and client engagements and the way we collaborate, operate and deliver value provides an unparalleled opportunity to grow and advance.  Choose Accenture, and make delivering innovative work part of your extraordinary career.
People in our Client Delivery & Operations career track drive delivery and capability excellence through the design, development and/or delivery of a solution, service, capability or offering. They grow into delivery-focused roles, and can progress within their current role, laterally or upward.
The Safety Monitoring Programmer in Woodcliff Lake, New Jersey collaborates with the client team to define safety reporting specifications, and program Java-Review reports and listings according to specifications. They provide for integrated study database automation and programming.  They assure Ongoing Safety Monitoring System (OGSM) automation, maintenance and programming. Perform Unix Administration and Java-Review maintenance as needed.
Key Responsibilities:
  • Strictly adhere to Accenture Standards (and client’s, as applicable) including standard operating procedures, guidance documents, and policies; operational and service level agreements; metrics and quality measures
  • Accountable for delivery of contracted commitments within budget and accuracy of all project information including, forecasts, costs and timelines for assigned project(s)
  • Support and identify areas for automation & innovation as process enhancements to improve quality of work or efficiencies in ways of working (e.g. continuous improvement)
  • Support strategic initiatives and Accelerated Research & Development Services (ARDS) cross functional offerings
  • Support client relationship development, account planning and growth 
  • Act as onsite presence at target account(s) to build and execute client relationship plans
  • Address technical challenges that connect Statistical analysis Systems (SAS), Clinical Data Interchange Standards Consortium (CDISC) and Extensible Markup Language (XML).
  • Development and implement clinical standards in a global pharmaceutical environment.
  • Integrating SAS with other leading technologies such as XML, Microsoft Office, to support electronic submissions.
  • May annotate Case Report Forms (CRFs) in accordance with CDISC published or company specific guidelines with appropriate metadata to reflect case report tabulation data sets.
  • May review and provide quality assurance to CRF annotations produced by other programmers
  • Review and provide quality assurance to datasets and programming specifications produced by other programmers
  • Develop and maintain cross-functional / cross-department processes related to clinical trial data production, including specifications, programming, Quality Control (QC), and deliverables of data for analysis and submission
  • Execute processes related to clinical trial Study Data Tabulation Model (SDTM) data production, including specifications, programming, QC, and deliverables of SDTM data for analysis and submission
  • Engage appropriate stakeholders in communication to create data standards and process for transition of clinical data to SDTM
  • Collaborate with client team to develop dataset requirements for SDTM, SDTM+, in production.
  • May be accountable for datasets specification, conversion, and delivery to stakeholders, specifically Statistical Programming, but also other users of datasets, on time and with high quality
  • Provide data production technology consultation to client Clinical Data Operations team related to dataset delivery and manage the activities of a team with a common focus
  • Responsible for Java-Review and Unix Administration and writing Shell Scripts
  • Perform integrated study database automation, programming and maintenance; develop macros as needed
  • Perform Ongoing Safety Monitoring System automation, maintenance and programming

Basic Qualifications:

  • Bachelor’s degree
  • Minimum of 8 years of programming and drug development experience in Clinical Research Organization (CRO), Pharmaceutical or Biotech organizations (preferably in Phase I-IV trials)

 Preferred Qualifications:
  • Strong skill in Clinical Data Interchange Standards Consortium (CDISC) standards and applicability to clinical database design / capture and reporting
  • Previous experience in clinical report and listing development, especially Patient Profiles for clinical trials
  • Strong SAS programming skills (at least 5 years SAS experience preferred)
  • Expert knowledge in clinical trials with 5+ years’ experience working in a clinical project team environment meeting deadlines with quality deliverables
  • Experience in use and administration of Java-Review application
  • Knowledge, development and use of macros in data automation
  • Proven experience in development and implementation of clinical standards in a global pharmaceutical environment.
  • Experience in consulting projects dealing with the assessment, design and/or implementation of CDISC data standards in the clinical data life cycle preferred
  • Experience in working in a global team setting
  • Ability to lead and manage functional teams to meet defined goals
  • Good problem-solving skills and ability to reach mutually acceptable solutions
  • Act as a team player in client and internal projects / initiatives
  • Knowledge of Pinnacle 21

  • Knowledge of and use of Spotfire and Java-Review applications

  • Knowledge of Clinical Data Repository concepts and functionalities

Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Accenture (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).

Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
Accenture is a Federal Contractor and an EEO and Affirmative Action Employer of Females/Minorities/Veterans/Individuals with Disabilities.
Equal Employment Opportunity
All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.
Accenture is committed to providing veteran employment opportunities to our service men and women

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