- Merck & Co. (Rahway, NJ)
- … clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents. Partners with Study Manager on study ... team members including clinical directors and study managers to lead/support clinical trial scientific activities in the Atherosclerosis & Metabolism TA.Job… more
- 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …immunology, or complex disease therapeutic area experience required- Working knowledge of Clinical trial data systems such as Medidata Rave (EDC), Metadata ... centered around rare diseases and immune disorders. Summary The Manager , Clinical Data Standards is responsible for...or related field required Experience Qualifications - 4+ years clinical data management experience required- 5+ years… 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...disease therapeutic area is a must. Working knowledge of Clinical trial data systems and/or EDC and… 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 ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… 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)
- …resolve issues with the reconciliation. Essential Skills + 4 or more years of trial management experience at a biotech or pharma company. + Hematology ... in accordance with standards. + Act as the project manager of the clinical study team to...experience. + Global trial management experience. + Experience with Phase… 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. ...Ability to manage any component of full cycle study management , from start-up to close-out. + Advanced knowledge of… more
- Hackensack Meridian Health (Hackensack, NJ)
- …meetings as required. + Serves as a Super User and team resource for the Clinical Trial Management System, Electronic Medical Records System, and all other ... comprehensive workflows and project/patient tracking procedures and tools to ensure ongoing clinical trial compliance across the assigned Research Program or… 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...vendor management + Advanced technical proficiency in trial management systems and MS applications including… 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...with instruction + Provide regular and timely updates to manager / management as requested + Develop Protocol and… 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...with instruction + Provide regular and timely updates to manager / management as requested + Develop Protocol and… 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 ... field; Masters preferred + 6+ years of experience managing clinical trials, including 2 years in a management... and leadership skills **Responsibilities** + Manages and coordinates clinical trial and related research studies conducted… 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
- Pfizer (New York, NY)
- …the drug development process and data operations required for the reporting of clinical trial data. **Qualifications** **Must-Have** + Bachelor's Degree + 7+ ... in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities… more
- Merck (Rahway, NJ)
- …Management Section of the GCS Planning organization. Working independently, the Inventory Manager Clinical Supplies Project Manager (IM CSPM) creates ... our depot network and further through to distribution and management of materials to the clinical site....but are not limited to:** + Participates on the Clinical Trial Team(CTT)and collaborates closely with other… 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
- IQVIA (Linden, NJ)
- …Functionally responsible for all team members throughout the duration of each clinical trial . Assures clear client communication, process documentation, and ... health-related field with at least five (5) years direct clinical trial experience in a CRO or...a scientific/ clinical environment is required. * Demonstrated Clinical Monitoring and/or Data Management experience required.… 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
- American Heart Association (Jersey City, NJ)
- …this role, you will be responsible for developing and implementing an accessible clinical trial database design by analyzing data inquiry needs, ensuring ... American Heart Association has an excellent opportunity for a ** Clinical Data Manager ** in our **National Center**...Provide or facilitate training on use of claims and/or clinical trial data as needed through group… more
