1+ months
2018-06-122018-09-27

Clinical Data Designer Associate Manager - Woodcliff Lake, NJ

Florham Park, NJ 07932
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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 worlds
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. Were 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.





Accomplishments:



+ 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



Accomplishments:



+ 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



Regulatory Accomplishments



+ 350+ clients


+ One of the largest users of the FDAs electronic gateway


+ Support over 90 countries



Job Description






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.





Key Responsibilities:

+ Strictly adhere to Accenture standards (and clients 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







Job Requirements:


Expect 80 100 % on site time at client site in Woodcliff Lake, NJ

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Clinical Data Designer Associate Manager - Woodcliff Lake, NJ

Accenture
Florham Park, NJ 07932

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