Oracle LSH and Medidata Rave Consultant

Oracle LSH and Medidata Rave Consultant

Location: morristown, NJ

General Summary:

This position will provide engagement management, technical leadership, and senior level consulting to clients in support of clinical operations.

Responsibilities:

·      Lead process definition and implementation strategy for the Medidata product suite.

·      Define and lead integrations activities for data import and export of data collection environment (e.g. RAVE).

·      Collect user requirements.

·      Lead software tool evaluation activities.

·      Establish implementation strategy for data review toolkits.

·      Plan and implement quality and reconciliation activities for integrations within studies.

·      Business lead for validation activities related to tool and integrations release.

Experience:

·      Must be willing to travel, if needed

·      Bachelor's Degree or 10+ years of relevant IT experience.

·      Must have 3-5 years of In-depth experience in design and developing tools and utilities on commonly used technology platforms (e.g. RAVE, LSH, SpotFire, SQL, SAS).

·      Must have functional understanding of Oracle Life Sciences Hub and significant hands-on experience with implementation or customization.

·      Must have detailed understanding of clinical data including data constructs and data models for pre-clinical, clinical, and post clinical data.

·      Must have understanding of the analysis and reporting needs within the clinical domain space.

·      Some familiarity with industry standards on integration technology (e.g. web services, and xml) is desired.

·      Understanding of global regulatory requirements, rules and guidances' associated with Source Data in Clinical Investigations including CFR part 11.

·      Experience in comprehensive software validation activities using different methodologies (i.e. waterfall, agile etc.), inspections, analyses, and other verification tasks performed at each stage of the software development life cycle;

·      Effective written and verbal communication in English and usage of Microsoft Office;

·      Experience in project management tasks and managing multiple integrations.

·      Effective interaction and training of teams in the understanding and usage of standards and technology is desired.

·      Strong verbal and written communication skills.

·      Able to work as a team player, lead a team or accomplish tasks without supervision.

·      Ability to work with remote teams and support several changes/projects simultaneously.

Sanjeev Thakur

Damcosoft, Inc.

112 W 34th St, 18th Floor, New York, NY 10120
Phone: (212) 389-9503 Ext.1164

Email: sanjeev.thakur@damcosoft.com
 

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