- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(SP&L) function with assigned tasks related to steady supply of Clinical Trial Materials (CTM).ResponsibilitiesLead the authoring, revising, and managing ... authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate will… more
- Eisai, Inc (Nutley, NJ)
- … Clinical Investigator Site Audits, Vendor Audits, GCP Document Audits ( Clinical Study Reports and Trial Master Files), internal Process Audits and ... May provide training on GCP and current regulations for those undertaking clinical studies.Job SummaryThe Associate Director, GCP Quality Assurance works within… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good … more
- Merck & Co. (North Wales, PA)
- …or related field plus 9 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life ... 7 or more years SAS programming experience in a clinical trial environment. Department Required Skills and...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Merck & Co. (San Francisco, CA)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Merck & Co. (San Francisco, CA)
- …(popPK), PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into ... our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This...seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisionsFraming… more
- Merck & Co. (Rahway, NJ)
- …Develop model-based strategies ( translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within ... all phases of drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions. Represent QP2 on cardiometabolic and… more
- Merck & Co. (North Wales, PA)
- …or related field plus at least 7 years SAS programming experience in a clinical trial environment OR a Bachelor's degree in Computer Science, Statistics, Applied ... field plus 9 years SAS programming experience in a clinical trial environment. Required Skills and Experience:...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Genmab (NJ)
- …of all aspects of clinical drug development, with particular emphasis on clinical trial design, trial execution, and strong knowledge about the ... feasibility and allocation process of a program and/or study.Must understand the Clinical Trial matrixed process from research through post-marketing Phase IV,… more
- Merck & Co. (Rahway, NJ)
- …development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process ... Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Rahway, New...working a Hybrid work consisting of three total days on- site per week, Monday - Thursday, although the specific… more
- Beckman Coulter Diagnostics (Miami, FL)
- …degree in the life sciences or related field required with 5+ years of clinical trial experience in vitro diagnostics (IVD), medical device, or healthcare ... diagnostic tools that address the world's biggest health challenges. The Senior Clinical Research Associate for Beckman Coulter Diagnostics is responsible for… more
- US Tech Solutions (Cambridge, MA)
- …on TMFs to ensure completeness and readiness for audit/inspection + Contributes to clinical trial excellence initiatives **Main responsibilities and tasks** + Be ... responsible for **setting-up, monitoring verifying and archiving** the ** clinical Trial Master File (TMF)** + In... study creation and set-up for the country and site binders and the trial milestones. +… more
- Lilly (Indianapolis, IN)
- …proofs. + Review/approve allowable dating, stability justifications and retest dating for clinical trial (CT) Materials. + Provide Quality oversight for ... for providing quality oversight of all materials used in clinical trials. PRD QA CT Packaging is responsible for...as needed. + Assist with regulatory body audits and site self-inspections to ensure cGMP compliance. + Provide guidance… more
- Eurofins (West Point, PA)
- …with us today! POSITION SUMMARY: We have an exciting opportunity for a leader with a clinical trial background to help stand up a lab in collaboration with our ... team of ~60 PSS employees for a PSS client site . POSITION RESPONSIBILITIES: + Support Associate Technical...years of experience + Management and training experience + Clinical trial experience + Experience working with… more
- Actalent (New York, NY)
- …creation, and ensure compliance with quality measures and timelines. + Monitor clinical trial performance and quality metrics, escalating issues and proposing ... and provide expert-level guidance. The position reports to an Associate Director and involves both strategic planning and operational...Qualifications + 7+ years of experience as a GLOBAL Clinical Trial Manager with a pharmaceutical or… more
- Cedars-Sinai (Los Angeles, CA)
- …patients with cancer! **Join our team and contribute to groundbreaking research!** The Clinical Research Data Associate II manages the data for assigned research ... analysis, and work with bioinformatics to develop and maintain trial management systems. Ensures compliance with all federal and...and beyond. **Req ID** : 8440 **Working Title** : Clinical Research Data Associate II - The… more
- J&J Family of Companies (Santa Clara, CA)
- …more at https://www.jnj.com **Job Function:** R&D Operations **Job Sub** **Function:** Clinical Trial Project Management **Job Category:** Professional **All Job ... Description:** Johnson & Johnson is hiring for a **Principal Clinical Research Associate - Shockwave Medica** l...study preparation activities, as applicable. + Develops and revises clinical trial documentation including clinical … more
- AbbVie (Chicago, IL)
- …This role will be assigned investigative sites in the Chicago, IL area. Focus on site clinical research that ensures appropriate conduct of the trial while ... staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment...+ Ensures audit and regulatory inspection readiness at assigned clinical site at all times. Manages investigator… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …& Logistics (SP&L) function with assigned tasks related to steady supply of Clinical Trial Materials (CTM). **Responsibilities** + Lead the authoring, revising, ... authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate will… more
- Taiho Oncology (Princeton, NJ)
- Study Associate I, Clinical Operations Princeton, NJ,...Knowledge, Skills, and Abilities: + 2 years of relevant clinical trial support or site ... team cultivating growth and learning. Position Summary: The Study Associate (SA) I is responsible for operational study support...to multi-task and effectively prioritize in order to ensure clinical trial goals. + Recognize potential obstacles… more
