- BioAgilytix (Durham, NC)
- …identifying roles in data engineering, quality, and automation as the function matures. Sponsor Data Delivery & Harmonization Own End-to-End Sponsor Data ... validation documentation is always ready for FDA, EMA, or sponsor inspection.Minimum Preferred QualificationsBachelor's degree in data science, Information… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to completion of desired project outcome (project core team, business sponsor , training sponsor , stakeholders, client group(s) etc.) Essential Functions ... Build and manage assigned curricula & measurement strategies within (mid-high complex curriculum and/or asset build to support individual contributor, 1st line leader, and 2nd line leader development) Effectively establish, deepen, and sustain key… more
- Genmab (NJ)
- …also welcome to apply.ResponsibilitieseTMF Management:Setup, maintain, oversee and close the Sponsor eTMF across trial, country and sites levels.Manage TMF health ... assigned processes and systems.Assist in the development and editing of Sponsor materials (SOPs and Work Instructions (WI)RequirementsBachelor's or Master's degree… more
- BioAgilytix (Durham, NC)
- …supplies for assaysResponsible for accurate record keeping with regard to sponsor 's samples, data, and reports (documentation according to GxP guidelines)Additional ... be authorized to work for ANY employer in the US We are unable to sponsor or take over sponsorship of an employment Visa at this time.BENEFITS AND OTHER PERKSMedical… more
- Merck & Co. (Rahway, NJ)
- …recognized clinical trial suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical ... trials from study initiation to completion and associated regulatory submission and inspection preparation. Preferred :Advanced degree, (eg, MD, PhD, Pharm D, MS, MBA)Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico… more
- Merck & Co. (Rahway, NJ)
- …Skills: 10-15 years of experience in clinical operations, preferably in Sponsor environment working - on multi-phase, multi-therapeutic and diverse clinical trials ... from study initiation to - completion and associated regulatory submission and inspection preparation Strong Leadership skills that will attract, motivate, inspire, develop and retain talented staff. - In addition, Leadership skills that enable and drive… more
- BioAgilytix (Durham, NC)
- …be authorized to work for ANY employer in the US We are unable to sponsor or take over sponsorship of any employment Visa at this time.BENEFITS AND OTHER ... PERKSMedical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Parental Leave, Paid Holidays… more
- Merck & Co. (Rahway, NJ)
- …and company goals. Preferred Experience and Skills: Experience, either at a sponsor or Contract Resource Organization (CRO), working on outsourced services for ... clinical trials.-Proficiency working in Excel and AribaSuperior analytical skills in evaluating complex research services budgets, comparing supplier bids and internal benchmarking data.Relevant experience may include clinical trials management, outsourced… more
- BioAgilytix (Durham, NC)
- …be authorized to work for ANY employer in the US We are unable to sponsor or take over sponsorship of any employment Visa at this time.Classification & Benefits:This ... is a part-time, non-exempt position. Please note that this role is not eligible for company-sponsored benefits.COMMITMENT TO EQUAL OPPORTUNITYBioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …questions and company positions related to CDx for Health Authority interactions (for both sponsor and partner side) CDx RA Policy and Intelligence : Keep abreast of ... the changing global regulatory environment for devices and share/educate CDx department on these changesAssessing the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical products… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at reasonable cost. Provides documented oversight of the external vendors/ sponsor partnership under the RD-wide vendor oversight structure. Strategically leverages ... external expertise in supporting RBQM activities.- Technical: Provides technical guidance in Quality by Design. Lead the team to define Critical to Quality factors, select critical variables and processes, and build appropriate mitigations. Drive interface… more
- Genmab (NJ)
- …questions related to data quality, safety monitoring, medical questions etc.Performs sponsor oversight of programming activities on the DM & Statistics ... vendorPerforms QC on SAS-code written by other Genmab colleaguesSupports submissions by ensuring that the programming-related part of the filing is consistent with current electronic submission standards and guidelines.Supports development of GenSense… more
- BioAgilytix (Durham, NC)
- …be authorized to work for ANY employer in the US We are unable to sponsor or take over sponsorship of any employment Visa at this time.The Sales Operations Analyst ... will play a critical role in supporting data-driven decision-making across BioAgilytix, by leveraging enterprise systems and data visualization tools to report critical business information. This role is responsible for gathering and integrating data to… more
- Eisai, Inc (Nutley, NJ)
- …specific documents and all other documents as requested by Clinical OperationsMaintains sponsor team member staff assignment list for Eisai systems eg. eTMF, EDC, ... IRTAssist with tracking SAE safety reports, collating information and providing updates to the CRO Initiates, tracks and collates clinical trial documentation related to CSR appendices. Act as central point of contact for the clinical team for designated… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to deliver relevant level of transparency in an effective and efficient way Sponsor , contribute to and drive projects that enhance Finance Department and overall ... Company performance Member of Retirement Committee providing input and oversight to Plan administration. Oversees financial reporting for employee benefit plans and serves as an advisor to Human Resources on other employee benefit matters concerning technical… more
- Genmab (NJ)
- …standards as appropriateLeads and or supports dry run processPerforms sponsor oversight (acceptance testing) of programming deliverables for outsourced studies ... Supports the establishment and maintenance of Genmab SDTM and ADaM database standards. Supports specification and pooling of data across clinical trials within the same project. Supports submissions by ensuring that the programming package is consistent with… more
- Beckman Coulter Diagnostics (Miami, FL)
- …templates (eg, study guides, studytools/worksheets) and ensure Trial Master File (TMF), Sponsor Site Files (SSF), and Investigator Site Files (ISF) are maintained ... and kept current; assist in audit readiness and preparation.Support the in-house biorepository by receiving, shipping, and tracking clinical study samples.May perform other clinical project activities such as drafting documents, reports, data summaries,… more
- Raytheon (Dallas, TX)
- …for a security clearanceSecurity Clearance: DoD Clearance: SecretRaytheon will sponsor clearance. Interim Clearance allowed.At Raytheon, the foundation of ... everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today's… more
- Raytheon (Tewksbury, MA)
- …for a security clearanceSecurity Clearance: DoD Clearance: SecretRaytheon will sponsor clearance. Interim Clearance allowed.At Raytheon, the foundation of ... everything we do is rooted in our values and a higher calling - to help our nation and allies defend freedoms and deter aggression. We bring the strength of more than 100 years of experience and renowned engineering expertise to meet the needs of today's… more
- Huntington National Bank (Minnetonka, MN)
- Description Job Summary: The Huntington Community Impact Capital ("CIC") Sponsor Underwriter Associate will assist in the sponsor underwriting of personal and ... housing tax credit (LIHTC) equity investments and debt facilities. The Sponsor Underwriter Associate's role is to understand and communicate sponsors' financial… more
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