- Genmab (NJ)
- …and authentic is essential to fulfilling our purpose.The Role:An Associate Director, Data Management is operationally responsible for the oversight of Clinical ... Data Management activities related to the effective planning, and...Genmab SOP/processes and standards and ICH-GCPProvides oversight of DM CRO including Statement of Work, budget, KPIs, and performs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on Study Team and collaborates as team member with other functions, ARO, CRO . Provides scientific input to Clinical Operations and other functions. This position ... Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager, Data Programmer is a member of the Biostatistics and Data Management ... trials. This position will work closely with other members of the Biostatistics and Data Management teams on various clinical projects and may function as the Lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data .- Drug Development Strategy: Provides ... sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor Oversight: Review CRO /vendor proposal and budget.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Research Organization ( CRO ) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility ... UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan (IDRP)Accountable for the… more
- Genmab (NJ)
- …eCRFs completion guidelines, and provide scientific support for other key data management deliverables (eg database lock activities). Lead the development of ... medical data review plan (MDRP), perform ongoing data ...project teams and CROs Prepare presentations for Investigator meetings, CRO /CRA training, SIVs as warranted Provide input for the… more
- BioAgilytix (Durham, NC)
- …HRIS programs that align with BioAgilytix's goals and culture. As a global CRO with locations across the US (California, North Carolina, Massachusetts), Germany, and ... regional needs. The Director will ensure HRIS systems operate seamlessly, drive data -driven improvements, and stay ahead of global and local industry best practices.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Development on Project Teams. ResponsibilitiesStudy Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data ... appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to systematic quality-related events specific to the external partner ( CRO , co-sponsor, specialty vendor).Support the Business Partner Quality Lead(s) (BPQLs), ... of lessons learned from audits and inspections.Support investigator meetings and CRO -relevant meetings by reviewing and contributing to the materials utilized to… more
- Genmab (Plainsboro, NJ)
- …responses to IEC/IRB commentsMonitor major protocol deviations (PDs) and trendsApprove data cleaning plansCollaborate with CPL as needed for CST/CDTEstablish and ... updated recruitment projections in alignment with CPLServe as the counterpart for CRO PL/PM, approving the CV of PL/PMRisk ManagementIdentify study risks with the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical terminology concepts and industry standards and technical skills in coding data received from CROs and vendors. This position requires solid verbal/written ... working knowledge of medical terminology capture and reporting of safety data , pharmacovigilance, industry best practices, and relevant regulatory requirements. This… more
- Genmab (Plainsboro, NJ)
- …if applicable Collaborate with the Labeling Team Lead to develop Company Core Data Sheet and US Prescribing Information depending on the role for the assigned ... with internal teams (eg QA, manufacturing), external teams (eg contract manufacturing, CRO , affiliates), and regulatory & health authorities, in relation to matters… more
- BioAgilytix (Durham, NC)
- …and qPCR techniques with the ability to perform assays independently in a CRO /CDMO environment. In this dynamic role, you will thrive in a milestone-driven ... environment, actively contributing to data generation while providing scientific input.As a Scientist I, your day-to-day activities will include:Run PCR assays… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... employee in clinical, medical and/or regulatory in the pharmaceutical industry (Pharma/Biotech/ CRO ) A minimum of 7 years supervisory experience required Experience… more
- Talen Energy (Baltimore, MD)
- Talen Energy is seeking Plant Technician- Control Room Operator ( CRO ) candidates to join our Operations team at our Brandon Shores power plant, located in ... safe operation. **Skills/Competencies:** 1. Thorough knowledge of all operating duties at control room installations. 2. Must thoroughly understand the function… more
- Streamline Innovations (San Antonio, TX)
- Job Summary: Streamline Innovations, Inc. is seeking a Control Room Operator for its San Antonio Area Command Center. We are seeking a skilled Control ... of natural gas sweetening process plants. As a Streamline Control Room Operator , you will...will be responsible for providing advanced condition monitoring and data analyses of critical plant systems and components, then… more
- AECOM (Milwaukee, WI)
- …by our common purpose to deliver a better world. Join us. **Job Description** The Control Room Operator (3rd Shiftwill work on-site at a Traffic Management ... traffic incidents. + Provides real-time status and situational awareness updates on control room activities such as significant incidents, special events,… more
- Talen Energy (Bangor, PA)
- Talen Energy is seeking Plant Control Room Operator (PCO) candidates to join our Operations team at our Martins Creek power plant, located in Bangor, PA. The ... adjustments to always maintain operating equipment at maximum efficiency. 5. Operates control room telephone switchboard and FM radio equipment. Communicates… more
- Cargill (NC)
- …experience troubleshooting various mechanical components and systems. + Prior experience as a control room operator + Prior experience using automation ... Tuition Reimbursement + Employee Discounts **Principal Accountabilities** + Process monitoring and control room systems and equipment + Assist in assuring… more
- WGNSTAR (Boise, ID)
- …interpret signals from the various alarm handlers and software applications within the control room + Responsible for monitoring equipment such as boilers, ... + In the event of a system failure, the CRO must be competent to assist in restoring the...Past experience working in a facilities, project, or mining control room or dispatch environment Preferred: +… more
