Clinical Data Designer Associate Manager - Woodcliff Lake, NJ/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 Clinical Data Designer Associate Manager in Woodcliff Lake, NJ collaborates with client business group teams and Accenture staff to enable development, deployment and maintenance of production clinical study databases. They also provide technical database and Information Technology (IT) related delivery solutions and clinical study technical support during study start-up, study conduct and study closeout phases of a clinical trial.
- 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 (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
- Participate in concept generation for new designs and applications including databases, reports, scripts and processes
- Create or provide input into project timelines and adhere to timelines; responsible for Key Performance Indicators (KPIs) and metrics.
- Develop clear, agreed upon specifications for the acquisition of external data types, oversee external data loads and Remote Data Entry (RDE) extract uploading
- Execute and/or oversee database maintenance activities
- Effectively communicate with internal and external customers as well as third party vendors
- Prioritize effectively and respond to urgent requests within internal team or from client
- Participate in cross functional meetings and drive initiatives to ensure the delivery milestones and timelines for clinical drug trials are met
- Coordinate as needed with the Oracle team and client, enforce data standards, and define the data reconciliation procedures
- Serve as IT liaison with key stakeholders and participate in meetings as needed
- Provide User Acceptance Testing (UAT) deployment support for multiple users
- Manage and oversee Post Production Change (PPC) deployments with key client stakeholders
- Provide RDE Statistical Analysis Systems (SAS) data extracts to the Study Data Tabulation Model (SDTM) team as needed
- Collaborate with key stakeholders to perform and manage project close-out tasks including database lock / freeze, unblinding, access changes and decommissioning activities
- Oversee all administrative project close-out procedures are completed. Participate and contribute to project close out meetings as needed
Can be worked remote, requires 3 days per month on site time at client site in Woodcliff Lake, NJ
+ Basic qualifications
- Bachelor's degree
- A minimum of 5 years of experience working with clinical trials in a technical clinical data operations/IT related role
- Experience with Oracle, InForm or Rave
- Technical experience preferred in a pharmaceutical development environment; Phase I-IV trials
- Prior successful troubleshooting of IT systems and enterprise applications in a pharmaceutical development environment (Phase I-IV trials)
- Knowledge of Electronic Data Capture (EDC) database design and functionality, as well as Interactive Response Technology (IRT) functionality and relationship to EDC
- A minimum of 3 years of successful experience managing or working with client teams for project delivery, project tools, and metrics
- Ability to lead and manage functional teams to meet defined goals
- Experience in working in a global team setting
- Ability to constructively manage internal team and client relationships
- Good problem-solving skills and ability to reach mutually acceptable solutions
- Act as a team player in client and internal projects/initiatives
- A minimum of 3 years of SAS programming experience
- Knowledge of Clinical Data Interchange Standards Consortium (CDISC) standards and applicability to clinical database design / capture and reporting
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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