- Merck & Co. (Rahway, NJ)
- …analyze, negotiate, and execute required site agreements and associated budgets including Clinical Trial Research Agreements (CTRA), Master Clinical ... within fair market value.--Works in partnership internally with GCTO (Global Clinical Trial Operations) country operations, finance, regulatory affairs,… more
- Merck & Co. (Rahway, NJ)
- …of accomplishments. Experience in Country Operations preferred. Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research ... Job DescriptionIt is critical that, for all company-sponsored clinical trials, patient safety, high quality data and...those objectives. -Under the guidance of the Regional Director, Clinical Quality Management (RCQM), the CCQM oversees all CQM… 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)
- …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
- 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)
- …deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… 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 (Parsippany Troy Hills, NJ)
- … 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
- Merck (Rahway, NJ)
- …comprehensive trial and site administration. Under the oversight of the Clinical Trial Coordinator Manager , the person prepares, collates, distributes, ... and archives clinical documents. The Clinical Trial Coordinator (CTC) supports ...role will collaborate at the local level closely with Clinical Operations Manager (COM), Clinical … 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
- Merck (Rahway, NJ)
- …trials. Job Responsibilities + Responsible for the operational planning, feasibility, and execution of a clinical trial . + May serve as the clinical trial ... and external data monitoring committee. + Managing team directly supporting the clinical trial **NOTICE FOR INTERNAL APPLICANTS** In accordance with Managers'… 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
- 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
- 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
