Argus Technical Consultant

Responsibilities: Argus Technical Consultant role engages with IT and business for the Argus migration activities. Conduct user requirement gathering for Argus migration and transform user requirements to functional requirements leading into migration and system design. Develop business process workflow diagrams and system level logical/physical architecture diagrams.
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Clinical Data Manager, Bridgewater, NJ - Katalyst HLS

Clinical Data Manager, Oncology is responsible for clinical data management activities for studies and ensuring FDA requirements for quality databases submissions are met. Perform and manage clinical Data Management (DM) activities for in-house and outsourced trials including protocol review, CRF (Case Report Form) development, database set up activities, data validation process (including manual data review of listings), and SAE (Serious Adverse Events) reconciliation, managing local laboratory and external labs and database lock. Represent DM on clinical teams, coordinate deliverables by other functions and/or CRO (Clinical Research Organization) as necessary to achieve DM deliverables. Coordinate with Programming team to provide support to the data review and safety updates (coordinate generation of data review listings, data retrieval to support data review and analysis, SDTM (Study Data Tabulation Model).
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Statistical Programmer, Jersey City, NJ - Katalyst HLS

Create and review annotated CRF to SDTM datasets. Responsible for the translation of the SAP into programming specifications for analysis data model (ADaM) datasets. Review and provide input on key study-related documents produced by other functions, such as case report forms, data management plan, statistical analysis plan and TFL specifications. Responsible for the development, review, validation, and execution of SAS programs to generate standard (SDTM and ADaM) and non-standard (custom study specific) datasets as defined in specifications documents. Responsible for the development, review, validation, and execution of SAS programs to generate presentation-ready outputs (i.e., Tables, Figures, and Listings), as defined in the statistical analysis plan.
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Validation Lead Consultant, Princeton, NJ - Katalyst HLS

Validate LIMS, Empower and whole host of other Pharma. Manufacturing shop floor applications. Should have strong validation, GxP pharma & GMP skills. General IT experience in business continuity, backup and recovery. Excellent Communication skills.
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Business Technical Analyst, Cambridge, MA - Katalyst HLS

Responsibilities include providing high touch IT support to business partners, including desktop and mobility support, technology upgrades, global webcasts and web chats, training, and ensuring readiness for key operating meetings. This role will also serve as the local site support of audio visual, collaboration, and server/data center support working with the owners of these towers to execute \"hands-on” tasks on their behalf. In addition, this position will manage projects within the local site, implement new technology platforms, act as a liaison between customers and other corporate IT teams, provide consulting and architectural reviews within area of expertise, and develop skills for self and peers.
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Process Development Engineer - Upstream, Greater Boston Area - Katalyst HLS

Applies principles of chemistry and engineering to solve problems involving the production and perform Upstream process development, including timely completion of small-scale experiments, scale-up, technology transfer and GMP floor support for programs that bring new biopharmaceutical products to pre-clinical, clinical and process validation manufacturing phases.
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Senior Statistical Programmer - South Plainfield, NJ - Katalyst HLS

Contribute to the creation, maintenance, validation and testing of standard SAS programs, standards for programming tools, outputs and macros using study metadata. Write, update, and maintain documentation. Provide training, guide and coach programmers.
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