- Daiichi Sankyo, Inc. (Bernards, NJ)
- …NOTE: This Project Lead Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling the on-time delivery of ... clinical supplies across the DSI portfolio. This role as...to CSO Supply Planning as requested.Responsible for updating relevant Trial Master Files (TMF) with CSO-related documentsSupports the CSO… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Degree preferably in Life Sciences required Experience Qualifications4 or More Years in clinical trial outsourcing, health sciences or related field ( clinical ... preferred.Excellent time management skills preferred.Experience with PH.1 - PH. IV clinical trial vendor contracts required.Experience with CRO contracts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …knowledge of CLIA/CAP regulations and GLP guidelines preferredBasic knowledge of clinical trial design; understanding of the overall drug development ... around rare diseases and immune disorders. Job Summary The Biosample Operations Manager , Biosample Management is responsible for supporting the oversight of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW:** Clinical Operations is responsible for the worldwide execution of all Phase ... I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in… more
- Astellas Pharma (New York, NY)
- …Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study ... apply. **Purpose and Scope:** The primary purpose of the Clinical Site Manager II (CSM II) is...sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures… more
- Merck (Rahway, NJ)
- …for your long-term goals. Our clinical team is recruiting for summer interns within the trial manager area of our company. The Trial Data Manager : + ... data, and patient reported outcomes. + Serve as project manager of all clinical data management activities...requirements for quality data collection and validation at the trial level. + Read and interpret the clinical… more
- Pfizer (New York, NY)
- …relationships with our partners, including patient advocacy organizations. The Head of Clinical Trial Diversity & Patient Engagement is responsible for ensuring ... & Recruitment Solutions (OARS) Leadership Team and leads the Clinical Trial Diversity & Patient Engagement Team....required **Other Job Details:** + This is a people manager role + Last date to apply is October… more
- Actalent (New Brunswick, NJ)
- Job Title: Clinical Trial Specialist Job Description As a Clinical Trial Specialist, you will be integral to the protocol activation process, ensuring ... the initiation and activation of new clinical trial protocols. This includes the preparation...list + Proficiency in using computerized systems like Sunrise Disease/ Clinical Manager , IDX, TDS, and Medical Records… more
- Terumo Medical Corporation (Somerset, NJ)
- Sr. Manager , Clinical Advisors Date: Sep 25, 2024...groups and health systems. + Drive the analysis of clinical trial data, prepare and report trial ... on medical and scientific questions/issues during trial follow-up phase). + Review CEC/DMC/ Clinical trial reports. + Provide medical- clinical trial … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + ... Ensures compliance with the clinical trial registry requirements + Identifies outsourcing needs of the study and leads and oversees engagement, contracting and… more
- Hackensack Meridian Health (Edison, NJ)
- …Investigators to educate all parties on the screening criteria for each Clinical Trial (Emergency Department, Clinical Laboratory, 3-Central, etc.). ... as a leader of positive change. The position of Clinical Trials Manager is responsible for the...for the acute stroke studies. + Keep inventories of trial supplies. + Track requests for payments as per… more
- AbbVie (Branchburg, NJ)
- …Trial Team(s) + Managing the project-related clinical development budget with the Clinical Trial Team and Project Manager + Ensuring that decisions ... Resolving project/functional conflicts + Managing, together with the Project Manager , the project budget and timelines + With the...responsible for: + Ensuring alignment between the IEST, and Clinical Trial Team(s) + Developing the proposed… more
- Abbott (New York, NY)
- …initiatives. The Clinical Lead Specialist is to support Abbott TAVI US clinical trial and commercial case coverage, trial enrollment and sales ... in collaboration with the Regional Sales Directors and the Clinical Lead Manager (CLM). This position will...proper patient selection. + Serving as primary resource for clinical trial and lead/coach/commercial case support, demonstrating… more
- Mount Sinai Health System (New York, NY)
- … Trials Manager , you will coordinate and manage multiple clinical trial projects and protocols, including federally funded studies, investigator-initiated ... + Strong management and leadership skills **Responsibilities** + Manages and coordinates clinical trial and related research studies conducted by the principal… more
- Bristol Myers Squibb (Madison, NJ)
- …Summary / Objective** + Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members ... activities associated with the conduct + May serve as Clinical Trial Lead for one or more...co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members **Position… more
- AbbVie (Florham Park, NJ)
- …the analysis and utilization of data + Performs analysis tasks in support of clinical trial integrity + Actively collaborates with DSS stakeholders to provide ... and large. Leverage emerging statistical methodologies to drive innovation in the clinical trial data realm. + Keep abreast of new and current including… more
- Vitalief (New Brunswick, NJ)
- …is responsible for preparing, maintaining, and negotiating budgets related to clinical trial activities. + Performs prospective reimbursement analysis according ... institutions, sponsors, attorneys, governmental agencies, and principal investigators. + Requests clinical trial budgets and contracts documents from sponsors… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager Clinical Scientist Hematology leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and ... interpretation of study data of a clinical development program. The Sr. Manager leads...clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists… more
- Mount Sinai Health System (New York, NY)
- …+ Thorough knowledge of Good Clinical Practice, Human Subject Protection, clinical trial design, regulatory processes, and clinical development process. ... **Job Description** The Clinical Program Manager provides clinical...attending physicians to identify and recruit patients eligible for clinical trial . + Establishes and maintains database… more