- Aequor (Thousand Oaks, CA)
- …biostatistics, stats programming, TA) to optimize trial delivery. Deep understanding of Risk Based approaches and its impact with Data Management/Site monitoring ... Remote- open market rate Purpose: To provide expertise in data management processes, demonstrating capabilities & new ways of...the model which will deliver studies with an appropriate risk -based approach, eg. reduced SDV etc Develop and document… more
- Novo Nordisk Inc. (Durham, NC)
- …& Subject Matter Expert (SME) to provide technical expertise supporting site data and digitalization efforts. Identify and share better practices, to include ... increasing awareness of data management standards & validation to create improvements in...within compliance with a quality mindset that focuses on risk management & mitigation Lead the training & implementation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …methodologies and technologies to deliver actionable insights and propel data -driven decision-making.Promotes a culture of creativity and risk -taking, ... safety, managing our supply chain and sampling, supporting technological and data innovation, maintaining our facilities and assuring the integrity and completeness… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function ... different disciplines and cultures. Must have technical knowledge on integrated data review and derivation/interpretation of metrics that can dynamically interface… more
- Repligen (Waltham, MA)
- …and supplier information. Data Analysis and Trend Reporting: Analyze NCMR data to identify recurring issues, high- risk suppliers, and common failure ... highly motivated and collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a key role… more
- Merck & Co. (Rahway, NJ)
- …products and non-our company marketed products . - Analyzes and anticipates project risk s as they relate to clinical supply chain deliverables and prepares , ... needed - Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio… more
- Merck & Co. (Rahway, NJ)
- …Management, Clinical Testing, Clinical Trial Management, Cross-Functional Team Leadership, Data Analysis, Detail-Oriented, Financial Risk Management (FRM), Good ... projects, etc.)-Demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate will also ... all dosage forms (liquid, lyo, drug-device combinations)Review and approval of data and technical documentsAbility to recruit, select, develop, and mentor… more
- Merck & Co. (San Francisco, CA)
- …execution of our Company's DSCS Digital Strategy to enable a seamless data infrastructure that drives increased speed, capacity and robustness across organizational ... team build and manage digital tools that enhance operational efficiency and data -driven decision-making. Under the broad guidance of the DSCS Digital Program Mgmt… more
- Merck & Co. (Durham, NC)
- …Meetings (with External Partner).-- Compliance:-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, ... provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner Site Readiness, Assist with Technology Transfer,… more
- Merck & Co. (Rahway, NJ)
- …needed. D emonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio ... decisions with facts and data Demonstrates ability to balance strategy with ability for tactical execution and has strong ownership & accountability of assigned work… more
- Eisai, Inc (Nutley, NJ)
- …artificial intelligence to provide deeper insights, building Eisai's capabilities in Data Driven Decision Making aligned to brand strategy and investment priorities. ... The role will also be involved with Eisai Ecosystem data projects helping to provide analysis to uncover patient...issues but also meet key business criteria (eg, cost, risk , business impact) and key technical criteria (eg, reliability,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategy, focusing on every touchpoint that impacts our customers. We leverage data and insights to inform our decision-making processes, ensuring that our ... across clinical, commercial, and enterprise domains. This role involves applying data interpretation and trend forecasting to identify market trends, leading a… more
- Formation Bio (New York, NY)
- …solutions to common program challenges, including resource constraints and risk mitigation strategies. Develop contingency plans for critical program elements ... planning for major program decisions. Synthesize technical, financial, and operational data to drive decision-making. Manage ambiguity by proactively identifying … more
- Merck & Co. (Rahway, NJ)
- …(MCAAS) primary purpose is to provide value-added independent and risk -based audit and assurance services.Position Overview / Function and ResponsibilityThe ... of the audits and assessments.Demonstrates knowledge of and techniques to assess risk and evaluate the effectiveness of internal controls in moderately complex… more
- Formation Bio (New York, NY)
- …maximize service quality and efficiency. Partner with Legal, Quality Assurance and Data Governance teams to understand and monitor vendor compliance with company ... policies, industry regulations (eg, FDA, EMA, GxP), and data security requirements. Identify opportunities for cost savings, contract optimizations, and risk … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)Serve as the Point of Contact ... of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk determinations (both submission to CDRH in a Q-sub process… more
- Merck & Co. (Durham, NC)
- …Financial audits, input to QSAT actions, to ensure compliance.Support the Master Data team with general Material Handling Steward tasksDrive safety, quality and ... process efficiencies and drive enhancements in storage capabilities.Work closely with master data center of excellence (COE) and site integrated process teams (IPT)… more
- Aequor (East Syracuse, NY)
- …deliverables within given timelines.Ability to problem solve and apply risk -based critical thinking in a technical environment.Demonstrated history of continuous ... and process improvements.Document and evaluate experimental results and perform data verification and trending.Provide technical expertise and guidance to support… more
- Insmed Incorporated (San Diego, CA)
- …guidelines.ResponsibilitiesResponsibilities (Essential Role Responsibilities):Establish and maintain a risk -based and scientific-based quality system to support ... and development of adverse trends) to ensure patient safety and data integrity.Supports strategic direction with cross functional working groups to identify… more
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