Oracle Argus Projects Consultant, NJ & CT

Oracle Argus Projects Consultant: Oracle Argus Safety support, maintenance & development. Experience with good understanding of Life Science domain with special focus on Clinical development and Pharmacovigilance / regulatory compliance Understanding customer business processes / requirements and analyzing their feasibility with respect to Life Sciences feature and functionalities. Very good knowledge of Oracle Argus Safety suite with special focus on E2B area. Ability to Configure ESM Profile and understanding E2B transmission process
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Validation Engineer Katalyst HLS

Responsibilities: Should work on Validation specifically with products transfer environment. Experience in cleaning validation and autoclaves. Working on Technical writing, Deviation/Change control writing Generate/review/Approval of Cleaning Validation – WIP/CIP/SIP protocols Maintain and update Cleaning Validation Plan
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Validation Engineer Katalyst HLS

Responsibilities: Should work on Validation specifically with products transfer environment. Experience in cleaning validation and autoclaves. Working on Technical writing, Deviation/Change control writing Generate/review/Approval of Cleaning Validation – WIP/CIP/SIP protocols Maintain and update Cleaning Validation Plan
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Clinical Database Programmer Katalyst HLS

Roles & responsibilities: Lots of experience building studies in Medidata Rave/RaveX including building complex custom functionality. Experience with Rave Web services and creating custom reports Utilizes development tools to design databases in EDC (Medidata Rave must) and helps manage the lifecycle of the study database Serve as a primary technical point of contact for assigned studies Works closely with data management to develop eCRF specifications following CDISC/SDTM/CDASH format and automated edit checks Liases with the IT and QA groups to ensure tight communication, adequate support and quality deliverables Generates and maintains all required documentation, including specification versions, programming and validation efforts, in support of database build and maintenance Helps to maintain standard library of eCRFs and edit checks in the database design tool Troubleshoots issues with EDC, working with the EDC vendor as needed
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Clinical Contracts Associate Katalyst HLS

Duties and functions include: Develop, maintain and manage appropriate study documentation Collect, review and approve regulatory documents from clinical sites Initiate, maintain and reconcile Trial Master File Set up and maintain tracking systems and tools and report study metrics to support the clinical study Coordinate communication of tracking information within Study Team and to sites Manage and track clinical and non-clinical supplies
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Clinical SAS Programmer Katalyst HLS

Roles & Responsibilities: Provide programming needs to support client's requirements Work closely with statistical personnel to provide definitions, documentation, and review of derived variables needed to produce planned tables, listings, and graphs (TLGs) Generate tables, listings and graphs from clinical trial databases using SAS Develop, program, verify, validate and maintain clinical trial databases and data entry screens using SAS and related software Develop data and programming specifications jointly with other programmers
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Clinical Data Manager Katalyst HLS

Duties and Responsibilities: Acts as the data expert and represents CDMT on study team as applicable Works with CRO to ensure data collection tools capture protocol requirements Identifies and resolves data flow process issues in collaboration with the project team Defines data handling conventions, quality acceptance and auditing criteria for data collection and data deliverables Provides guidance and sponsor approval per CRO SOPs and process exceptions
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Clinical Data Manager job - Katalyst HealthCares & Life Sciences - Basking Ridge, NJ

April 12, 2018 - Clinical Data Manager - p b Job Description: /b /p ul li The Clinical Data Manager will provide clinical data management services across assigned projects including CRF
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Statistician Katalyst HLS

Responsibilities: Provide statistical input into the design of protocols including preparation of the biostatistical analysis section. Suggest optimal statistical designs that are acceptable by regulators Prepare statistical analysis plans including table shells. Analyze and report results of clinical trials. Provide tables, listings and graphs for final study reports. Provide ad hoc / data driven analyses. Provide statistical input for the preparation of final study reports and other required documents. Provide statistical support for integrated reports, submissions preparation, and post-submission activities. Contribute to clinical development plan
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Senior Windows Engineer job - Katalyst HealthCares & Life Sciences - South Plainfield, NJ

April 16, 2018 - Senior Windows Engineer - p b Job Responsibilities: /b /p ul li Responsible for our Windows build machines within our Regulatory Clinical Solutions group. /li li Provide
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Regulatory Specialist job - Katalyst HealthCares & Life Sciences - Groton, CT

April 16, 2018 - Regulatory Specialist - p b Overview: /b /p ul li Regulatory Specialist / Associate with exeperince in Medical device regulatory filings of /li li Product transfer
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Senior Quality Engineer job - Katalyst HealthCares & Life Sciences - Warsaw, IN

April 16, 2018 - Senior Quality Engineer - p b Job Description: /b /p ul li Coordinate design Assurance activities in support of product development and life cycle processes between
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Senior Statistical Programmer job - Katalyst HealthCares & Life Sciences - Remote

April 16, 2018 - Senior Statistical Programmer - p b Job Responsibilities: /b /p ul li Provides statistical programming support for project. /li li Reviews protocols, CRFs, statistical
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Clinical Trials Manager Katalyst HLS

Job Description: The Clinical Trial Registration and Results Disclosure Workstream lead (WSL-CTR&R) will be an expert on listing clinical trial protocol and trial results on public websites (ClinicalTrials.gov, EudraCT, EU PASS, Germany and company webpage). As the WSL-CTR&R, he/she will oversee all work outsourced to the vendor and is responsible for ensuring compliance with legal/regulatory requirements (e.g. US Final Rule) and industry commitments (e.g. PhRMA/EFPIA Principles). On an ongoing basis, the WSL-CTR&R will communicate with the vendor, the internal Program Leads, and the internal head of Clinical Trial Transparency (CTT) business operations.
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Clinical Trial Specialist Kataltst HLS

Job Description: Clinical Sciences (CS) is the bridge from preclinical research to clinical development and optimally addresses patient's unmet needs to maximize the value of 's development portfolio thereby making happen "Science for a better life ".
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Senior Statistical Programmer KATALYST HLS

Job Description: The Senior Statistical Programmer provides Statistical Programming technical leadership and support to team members. He/She delegates tasks appropriately and tracks progress. The Senior Statistical Programmer may also construct estimates of project resource requirements and time lines and routinely briefs management on accomplishments, status of projects, and any issues. In addition, the Senior Statistical Programmer is a designated member of clinical subteam(s) in the role of project lead Statistical Programmer for a limited number of studies. Key Responsibilities: Effectively designs and codes SAS programs for assigned project(s), consistently meeting objectives of the project Codes complex SAS programs for applications designed to analyze and report complex clinical trial data and for electronic submissions of data in CDlSC format with minimal instruction or input from supervisor Provides guidance on the resolution of highly complex clinical trial reporting p
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Drug Safety Associate Katalyast HLS

Job Description: A pharmaceutical client has recently lost a Drug Safety Associate and looking for someone to back fill the role for 6-12 months. Ideal candidates would have QC and coding experience in drug safety capacity. This role will be assisting the client with case processing writing case narratives and queries. Top Technical skills: QC skills and experience Argus coding experience 5 - 8 years of Drug Safety experience
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Clinical Data Manager Katalyst HLS

Roles & Responsibilities: Lead studies as the Lead Data Manager or support other lead team members with ongoing project work, as determined by business need and relevant skillset Liaise between study personnel and the client, as appropriate, regarding clinical and/or technical issues Develop and/or review case report forms (CRFs) within =EDC system Author or perform quality control review of data management documents, such as CRF Completion Guidelines (CCGs), Data Management Plans (DMP), and Data Transfer Plans Develop or quality control review Data Validation Specifications (DVS) documents Participate in programming edit checks and other system functions within EDC as needed
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Trial Supply Manager Katalyst HLS

Job Description: This individual contributor is responsible for the management of clinical supplies during the execution phase of clinical trials consistent with GMP guidelines Adopt supply strategies in view of changes in trial execution and ensure a seamless transition from study design phase Assess clinical study recruitment rates and ensure supply planning is adopted accordingly Utilize business tools to manage inventories at depots and sites and ensure on-time delivery with minimal overage of clinical supplies Conduct issue resolution activities for supply aspects of clinical studies (e.g., packaging, distribution) Establish and modify trial specific distribution agreements
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Computer System Validation Engineer Katalyst HLS

Job Description 7+ Years of in an IT Software Quality Analyst or Quality consultant is required. experience in Computer Systems Validation environment with at least 2 years performing in the IT Quality and Compliance and/or data integrity roles. Must have Pharmaceutical, Bio-Technology, or Life Science industry experience.
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Regulatory Affairs Lead Katalyst HLS

Required Skills: Candidates who has worked in Regulatory Affairs in any Medical device companies. Candidates who has worked in Notified Bodies such as TUV, UL, BSI, SGS, Intertek etc with exposure to Medical device regulations. Relevant experience in Drug Safety case processing, drug safety database (e.g. ARISg or Argus), MedDRA and WHO-DRUG dictionaries Experience with performing quality checks on SAE reports, AE/SAE reconciliations.
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Regulatory Affairs Lead Katalyst HLS

Required Skills: Candidates who has worked in Regulatory Affairs in any Medical device companies. Candidates who has worked in Notified Bodies such as TUV, UL, BSI, SGS, Intertek etc with exposure to Medical device regulations. Relevant experience in Drug Safety case processing, drug safety database (e.g. ARISg or Argus), MedDRA and WHO-DRUG dictionaries Experience with performing quality checks on SAE reports, AE/SAE reconciliations.
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