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Provides input to Clinical Operations on monitoring plan (e.g. data fields to be SDV’d) and to Biostatistics on Statistical Analysis Plan (SAP). Contributes along with CSL and/or Medical Monitor to development of study design to meet study objectives, development of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan.
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As a Data Engineer on the team, you will contribute to the scalable Batch and Streaming ETL pipelines , DWH design and Data modeling, Data Governance initiatives tools and applications that make that data available to other teams and systems.
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At least 10 years of extensive experience and deep understanding of different types of syndicatedcommercialpharmadatasets across Claims, Retail Sales, Non-retail Sales, Trade data, Specialty Pharmacy (SP/SD), Hub, Formulary, Co-pay, Prescriber-Plan data, EMR/EHR, Diagnostic data, Shipment, Inventory, Non-personal Promotion data, Speaker Programs, Email Campaigns, Digital Data (HCP Portal, Patient Portal, Brand websites, Third-party website), Conferences etc.
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Knowledge of cGMP, GxP, GAMP, and SDLC regulations, including 21CFR part 11 electronic records and electronic signatures, and good documentation practices with the ALCOA+ principles of data integrity, risk-based approaches to validation, Computer Software Assurance (CSA) principles.
Full-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Oversee outside counsel and patent litigation including coordinating discovery, expert retention, and providing substantive input on legal strategies and settlement negotiations. Provide input and assistance to other departments and counsel on the proper approach to matters involving potential litigation or the risk of litigation.
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Proficiency in Microsoft Azure cloud services, including Azure Data Factory, Azure Databricks, Azure SQL Database, Azure Data Lake, etc. MHA provides expertise in Group Purchasing, Managed Care and Payer Contracting, Reimbursement Management, Specialty Pharmacy Solutions, Pharmaceutical Data Analytics, Consultant Pharmacy Software and Legislative Advocacy.
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Supervise clinical staff to ensure all study activities are completed in accordance with applicable regulations and guidance, ICH, GCP and Bausch Health SOPs. Responsible for the quality of all study-related documentation (e.g., Trial Master File, site qualification and initiation visits reports, interim monitoring visit reports, clinical monitoring plan, informed consents, CRF completion guidelines, pharmacy manual, etc.
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Is accountable for inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements. This position also requires knowledge of external data concepts, working knowledge of data collections (EDC & Non-EDC), industry standards (CDISC / SDTM), and technical skills for integrating and importing external data received from CROs, vendors and other Partners.
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Collaborating amongst team members across several geographies, our Cloud practitioners engineer cloud-based analytics solutions on AWS, Azure, Databricks, GCP, Snowflake, Oracle, Informatica Cloud and a combination of native cloud technologies, including computing at edge and curating data-in-motion.
$119,025 - $198,375 a yearFull-timeExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Knowledge of documentation in electronic medical records and sending images to Sectra/PACs system. 3-5 years of experience as an Interventional Radiologic technologist or a Cardio-Vascular technologist with NJ radiographic licensure.
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This role is similar to a cardiovascular technologist ( CVT) but MUST have radiographic licensure to operate x-ray fluoroscopic modalities. Role: Interventional Radiology Technician. Candidate submissions must have an Atlantic Health coversheet identifying schedule, COVID-19 status (Vaccinated or exemption) and Certifications.
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Expertise in Big data technologies such as Spark, Hadoop, Databricks, Snowflake, EMR, Glue. The Databricks Software Engineering Senior Advisor (Software Engineering Senior Advisor) demonstrates expertise in data engineering technologies with a focus on engineering, innovation, strategic influence, and product mindset.
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Critical aspect of the role includes defining an agile quality and compliance strategy that supports Digital Data unit in their effort to establish a standardized, resilient, and sustainable data pipeline - including data sources, data quality, data governance, data management and master data management.
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Collaboration: Work closely with cross-functional teams within business, finance, and Capital and MRO to align procurement strategies and business needs by soliciting regular input, sharing best practices and wins, and escalating issues with the Head of Indirect Procurement as needed.
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Oversees and provides input to the development of study specific documentation including but not limited to: case report forms (CRF), data management plan, monitoring plan, monitoring oversight plan, project specific training plan, data review plan, statistical analysis plan, etc.
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data input documentation jobs in Basking Ridge, NJ
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