- Merck & Co. (Rahway, NJ)
- …clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... and prioritization skillsAdvanced analytical skills with the ability to interpret clinical trial data andsynthesize conclusionsInteract with key stakeholders… more
- Merck & Co. (Rahway, NJ)
- …and posters/oral presentations that report results from our company's General Medicine clinical trial program, as well as select early-stage development projects ... Skills Strong writing skills and competence in biomedical research General Medicine clinical trial publications experience Understanding of clinical research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development ... centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end...disease therapeutic area is a must. Working knowledge of Clinical trial data systems and/or EDC and… 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 Manager , Bio Sample Operations is responsible for supporting the...of Bio samples (PK/ADA , CDx and biomarker) in clinical trials from study start-up to close-out including but… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and suggest innovative approaches to improve compliances and processes.Some knowledge of clinical trial methodologies. Travel:Ability to travel up to 10% Daiichi ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to… 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
- Actalent (New York, NY)
- … clinical study team in accordance with standards. + Act as the project manager of the clinical study team to liaise and coordinate with internal stakeholders ... Job Title: Clinical Study ManagerJob Description The incumbent will be...audit activities. + Provide oversight of the transmittal of trial and site-level documents to the Document Control Center… 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
- IQVIA (Bridgewater, NJ)
- The Associate Clinical Project Manager /Local Trial Manager is a member of the core project team responsible for project delivery of clinical studies ... the Project Lead for partnering in overall project management, Clinical Lead for site management, the Project Management Analyst...coordination, tracking and financial analysis, and the Site Activation Manager as an expert in start-up. This is an… more
- IQVIA (New York, NY)
- …At least 5-7 years of experience in a global Senior CL ( Clinical Lead) / CTM ( Clinical Trial Manager )/ CTL ( Clinical Trial Lead)/ COL ( ... Clinical Operations Lead) role, overseeing global trials / trial portfolios / clinical trial operations, with the majority of your experience focused in… more
- Hackensack Meridian Health (Hackensack, NJ)
- …comprehensive workflows and project/patient tracking procedures and tools to ensure ongoing clinical trial compliance across the assigned Research Program or ... Management Team, this role will be responsible for developing clinical trial and patient flow manuals of...**Responsibilities** A day in the life of a **Project Manager , Clinical Trials** at Hackensack Meridian _Health_… 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
- Bristol Myers Squibb (Summit, NJ)
- …clinical studies and programs. This position involves leading and executing clinical trial activities, collaborating with cross-functional teams, and liaising ... Will be responsible for design and execution of assigned clinical trial activities and work closely with...co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members **Position… 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
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and batch traceability. + Oversees CPOs to ensure compliance with GMP, GCP, applicable Clinical Trial Regulations and agreed Work Orders and Clinical Supply ... and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete...years of experience in labeling, packaging and distribution of clinical trial materials. + Experience in managing… more
- Abbott (New York, NY)
- …scope of the Clinical Sales Specialist (CSS) role is to provide TAVI clinical trial and commercial case support, trial enrollment & education initiatives ... On** This position is responsible for the following TAVI clinical trial & commercial activities with key...& communication skills. This position collaborates with the Territory Manager , Regional Sales Director, Clinical Lead Specialist… 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)
- …and may author clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists with and may author/review ... The Senior Manager , Hematology, Clinical Scientist leads in...ICH/GCP guidelines. We are seeking a proven track in clinical trial process improvements. We need prior… 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
