- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... study leader (CSL)Study Planning and Execution: Provides input on major milestones of trial , clinical trial plan and contingency planning; Analyzes and… more
- Genmab (NJ)
- …of all aspects of clinical drug development, with particular emphasis on clinical trial design, trial execution, and strong knowledge about the ... to have you join us!The Role & DepartmentThe Feasibility Lead supports the vision and strategy set forth by...allocation process of a program and/or study.Must understand the Clinical Trial matrixed process from research through… more
- Eisai, Inc (Nutley, NJ)
- …May provide training on GCP and current regulations for those undertaking clinical studies.Job SummaryThe Associate Director, GCP Quality Assurance works within ... relationships with internal and external stakeholders and be the Lead Quality Assurance representative to clinical teams... Investigator Site Audits, Vendor Audits, GCP Document Audits ( Clinical Study Reports and Trial Master Files),… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures. Clinical trial ... of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and laboratory data expertise to promote and implement best practices across the Clinical Trial lifecycle.- Applies GCP principles to ensure all laboratory data ... similar environment (eg, CRO); oncology, immunology, or complex disease Strong knowledge of Clinical trial data systems and/or EDC lab management. required- 4+… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure successful implementation of the CDx and associated data collection. Oversees clinical trial sample testing activities and data capture to support CDx ... the Dx partner for CDx project contracts. Supports CDx analytical and clinical validation studies in collaboration with Dx-partner Provides scientific and technical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis- Develop and maintain necessary programming macros ... build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities:- Supporting project lead on outsourced projects, act as statistical programming subject matter… more
- Lilly (Indianapolis, IN)
- …for people around the world. **Purpose:** The purpose of the Clinical Trial Registry and Transparency (CTRT) Associate is to support the development and ... development to ensure/coordinate the accurate and timely posting of applicable clinical trial protocol information and study results. **Primary… more
- Lilly (Indianapolis, IN)
- …for people who are determined to make life better for people around the world. Associate Director- Clinical Trial Foundations Purpose: The Associate ... Trial Foundations (CTF), will serve as the subject matter expert for clinical systems and capabilities supporting clinical development. In this role, you… 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...and audits. + Ability to influence team interactions and lead initiatives. + Must exhibit attention to detail. +… 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 involves both strategic planning and operational execution of clinical studies. Responsibilities + Lead the development...Qualifications + 7+ years of experience as a GLOBAL Clinical Trial Manager with a pharmaceutical or… more
- Takeda Pharmaceuticals (Boston, MA)
- …management/oversight, including significant study management support experience (eg clinical trial assistant/ associate or lead CRA). + Experience could ... in Clinical Development Plan. In close collaboration with Clinical Operations Program Lead (s): + Oversee the execution of studies in assigned clinical… more
- Lilly (Indianapolis, IN)
- … process. **Scope -** Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make adjustments and changes (per ... ( Clinical Research Organization) clinical development point of contact ** Clinical Trial Process Leadership and Expertise** Leverage and demonstrate broad… more
- Takeda Pharmaceuticals (Boston, MA)
- …direct the execution of diversity and inclusion strategy and tactics for global clinical trial programs. + Accountable for the co-creation and implementation of ... Operations staff on the importance of diversity in clinical trial populations. **Accountabilities:** + May be...a role model for Takeda's values. + Represent and lead cross-functional initiatives. + Provides expert counsel for issue… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …function with assigned tasks related to steady supply of Clinical Trial Materials (CTM). **Responsibilities** + Lead 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
- University of Utah (Salt Lake City, UT)
- …Number** PRN42049B **Job Title** Research Dev Associate III **Working Title** Clinical Trials Operations Lead **Job Grade** G **FLSA Code** Professional ... the role includes mentoring research managers and coordinators to streamline clinical trial processes and deliver high-quality outcomes, aligning with… more
- Hartford HealthCare (Hartford, CT)
- …is primarily responsible for the overall design, conduct, and management of the clinical trial , the CRA leads, facilitates and coordinates all clinical ... us. *Job Summary:* As a specialized research professional the Clinical Research Associate (CRA) collaborates with the...with meeting the goals outlined in the protocol and clinical trial agreement * Motivate others, monitor… more
- Hartford HealthCare (Hartford, CT)
- …is primarily responsible for the overall design, conduct, and management of the clinical trial , the CRA leads, facilitates and coordinates all clinical ... us. *Job Summary:* As a specialized research professional the Clinical Research Associate (CRA) collaborates with the...with meeting the goals outlined in the protocol and clinical trial agreement * Motivate others, monitor… more
