- Parexel (Trenton, NJ)
- **Job Title:** Data Management Lead (Medical Affairs) - Oncology **Location:** Fully Remote (US based) Must be able to accommodate West Coast hours. **About ... innovative solutions. We are seeking a dynamic and experienced Data Management Lead to join our team....+ Advise teams and stakeholders on best practices for data collection, propose innovative solutions, and ensure high- quality… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …+ You will be responsible for planning and executing audits of vendors' quality management systems, manufacturing processes, and facilities to ensure compliance ... be responsible for regular monitoring and analyzing vendor performance data to identify trends and potential issues ....or medical device manufacturing, packaging and testing processes, and management of Quality Management Systems.… more
- Parexel (Trenton, NJ)
- …the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data . ... quality issue processes by escalating systematic or serious quality issues , data privacy breaches,...(CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management … more
- Parexel (Trenton, NJ)
- …Provide medical safety expertise to client per request + Review and sign off Data Management line listings (including adverse events, laboratory data , vital ... management tools, etc.) + Contribution to Safety Management Team (SMT) meetings: Data analysis/ review,...safety assessments, SERs, as necessary, for potential signals or issues (product quality ) + Perform review and… more
- Parexel (Trenton, NJ)
- …the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data . ... quality issue processes by escalating systematic or serious quality issues , data privacy breaches,...(CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management … more
- Parexel (Trenton, NJ)
- …clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written ... Research Associate (Sr. CRA) is responsible for the site management , site monitoring and close-out of assigned clinical trials...open issues and to prevent recurrence/persistence of issues + Resolve data queries within required… more
- Parexel (Trenton, NJ)
- …personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site ... Senior Clinical Research Associate (Sr. CRA) is responsible for the site management , site monitoring and close-out of assigned clinical trials investigator sites to… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …products. Supported by more than 40 manufacturing facilities, we provide high- quality medicines, trusted by healthcare professionals and patients, to more than ... clinical trial outsourcing, vendor selection and contract negotiation, vendor management , and reporting process for Sun Pharmaceuticals clinical development… more
- Parexel (Trenton, NJ)
- …. + Develop and train Medical Writing Services staff to enhance writing quality , efficiency, and project management . + Implement and monitor departmental ... team leadership skills and cross-cultural sensitivity. + Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate.… more
- Parexel (Trenton, NJ)
- …throughout a study's lifecycle, responsible for site start-up, activation, relationship management , recruitment, and quality assurance. This role also ... issues , and collaborates with various functions to optimize communication, maintain site quality and patient safety utilizing data analytics to identify and… more
- Parexel (Trenton, NJ)
- …the primary client contact, negotiating deliverable timelines, and resolving project-related issues . Project management of contractual and financial aspects may ... and mock statistical output to determine appropriateness of content/format for clinical writing. ** Quality Control** + Ensure that all work is complete and of high … more
- Parexel (Trenton, NJ)
- …Parexel you are in a client facing role which requires the consistent management of the proposal and contract management processes, development of ... revisions, with assistance, based on SME feedback and proposal management staff. + Manages the RFP process from receipt...are saved in the appropriate areas and keep all data updated regularly in systems used for metrics and… more
- Integra LifeSciences (Princeton, NJ)
- …ISO 11138, ANSI/AAMI ST 72and USP. + Support team members by interpreting microbiological data in order to identify trends and issues that require investigation. ... managing multiple teams and results oriented with a strong focus on quality principles. + Demonstrates excellent team management , organizational and… more
- Parexel (Trenton, NJ)
- …Manager with Parexel is a client facing role and requires consistent management of the contract management processes, development of client-specific standards ... and contracts deliverables. **Key Accountabilities** : **Contract Development:** + Overall management responsibility for the contract process for specific or varied… more
- Parexel (Trenton, NJ)
- …protocol and CRF development on specific studies + Lead production and quality control of randomization, analysis plans, statistical reports, statistical sections of ... sections for inclusion in study protocols + Provide statistical input into Data Monitoring Committee (DMC) activities, including development of DMC charters and… more
- MISTRAS Group, Inc. (Princeton Junction, NJ)
- …monitoring, maintenance planning, and specialized engineering, powered by a proprietary management software suite that centralizes integrity data for predictive ... positive work environment that values excellence in safety and quality , free from discrimination and harassment. Every MISTRAS employee...a workplace where all employees are free to raise issues , concerns, and questions for the improvement of our… more
- GCG (Trenton, NJ)
- …a high-visibility, strategic individual contributor role that bridges procurement, product management , quality , and commercial teams to deliver complex, ... Manage and communicate project timelines, deliverables, and risks across procurement, product management , quality , and sales teams + Support supplier onboarding,… more
- Verdantas (Trenton, NJ)
- …the communities we serve. We partner with clients to deliver smart, data -driven solutions to complex environmental and infrastructure challenges. We don't just solve ... that support land development and redevelopment, civil infrastructure, stormwater management , transportation projects, landfill design, dam safety, and litigation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …compliance, industry competitiveness and operational excellence Oversight of performance management : Facilitates regularly scheduled call quality calibrations, ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with a focus on corporate functions (eg, Procurement; Real Estate; Digital, Data and IT; Finance and Tax) and complex and high-risk supplier contracting. ... Provide Strategic Legal Counsel Interpret complex internal and external business issues related to contracting and recommend best practices and solutions Proactively… more
