Safety Monitoring Programmer - Woodcliff Lake, New Jersey/or Remote
Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions - underpinned by the world's largest delivery network - Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With approximately 425,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com.
This role resides within Accenture's Applied Life Sciences Solutions group. This group helps clients make a meaningful impact on patients' lives by combining new science with leading-edge technology. We're working with our clients to revolutionize how medical treatments are Discovered, Developed and Delivered. Helping 90% of the Fortune 500 life sciences companies (including all of the Top Ten) with 15,000+ life sciences professionals in 50+ countries.
Clinical Operations services we provide:
- Clinical data management services
- CDISC based clinical data conversion services
- Biostatistics and statistical programming services
- Clinical data transparency and disclosure
Accenture data operations professionals leverage their domain expertise for authoring data management plans, EDC database design, data review, reconciliation and coding.
- Processing and/or authoring of over 6.5 million case files
- Over 2,000 clinical databases created
- Over 900 clinical databases locked
Clinical Statistics and Programming services we provide:
- Collaboration with sponsor on Integrated Summary of Effective (ISE) and Integrated Summary of Safety Strategy (ISS)
- Pooling and analysis activities
- ISS/ISE Statistical Analysis Plan (including Mock Table Listings and Figures)
- ISS/ISE Analysis Datasets from pooled and standardized SDTM database
- ADaM Compliance
- Experience representing sponsors or preparing sponsors for FDA Advisory Committee meetings or respective regulatory authority
- Extensive technical knowledge and industry-leading CDISC standards expertise
- Proven track record includes the analysis of over 4,000 datasets
Regulatory Services we provide:
- Clinical Trial and Drug Application Submissions
- Clinical Data Transparency and Anonymization
- RoW Marketing Authorization Submissions
- Document and Dossier Re-formatting
- License Maintenance Submissions
- Dossier Consolidation, Gap Analysis and Remediation
- Submission Continuity Management
- 350+ clients
- One of the largest users of the FDAs electronic gateway
- Support over 90 countries
The Safety Monitoring Programmer in Woodcliff Lake, New Jersey c ollaborates 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 a ssure Ongoing Safety Monitoring System (OGSM) automation, maintenance and programming. Perform Unix Administration and Java-Review maintenance as needed.
- 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
Can be worked remote, requires 3 days per month on site time at client site in Woodcliff Lake, NJ
+ 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)
- 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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