- Insmed Incorporated (Bridgewater, NJ)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewAssist in the delivery of Clinical Operations objectives by providing operational support to the ... project plans, ICH/GCP guidelines, government regulations, etc.Provides operational support for the Clinical Operations team with heavy focus on study start‐up… more
- Merck & Co. (Rahway, NJ)
- …produce safe, effective, innovative medicine.We are seeking a Growth and Improvement minded Clinical Operations Manager - Regulatory that can help drive our ... are a Competitive Advantage for UsSummary, Focus and PurposeThe Clinical Operations Manager - Regulatory is accountable...the person is responsible for, execution and oversight of clinical trial country submissions and approvals and… more
- Merck & Co. (Rahway, NJ)
- …the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. ... to:Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).Oversees and tracks clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations line management experience Domestic and international clinical trial execution experience required Post-approval clinical ... this is a key new role to lead the Clinical Operations function across our Boston, MA...project portfolio anchored within the East Coast Hub, including trial planning, study / protocol design and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations . Represents Clinical Development on Project Teams. ... Collaborates as team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… more
- Merck & Co. (North Wales, PA)
- … clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical /scientific execution of clinical protocol (s).Serves as the ... lead clinical scientist on the clinical trial team.Collaborates with the Medical Writer...up)Lead medical monitoring team in review and interpretation of clinical data/medical protocol -deviations in collaboration with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to ... checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates… more
- Merck & Co. (Rahway, NJ)
- …and ensures continuity of site relationships through all-phases of the trial .-Performs clinical study site management/monitoring activities in compliance with ... site contact and site manager throughout all phases of a clinical research study,-taking overall responsibility of allocated sites.Actively develops and expands… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans ... compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio...start up, and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders… more
- Merck & Co. (North Wales, PA)
- …innovative medicine.Accountable for the operational planning, feasibility, and execution of a clinical protocol .- May lead team in key study planning, ... preparation of status update reports, study closeout activities).- May serve as the clinical trial team (CTT) lead. -Leads team for timeline management, risk… more
- Merck & Co. (Rahway, NJ)
- …the Encoder (ENC-I) is responsible for executing activities pertaining to the encoding of clinical trial data and supporting the Manual Encoding Lead (MEL) with ... Primary activities include, but are not limited to: - Accountable for all trial level encoding and execution of encoding reports (including handling of Milestone… more
- Merck & Co. (North Wales, PA)
- …management team.Review and provide clinical operations input into relevant clinical documents such as the protocol and other documents as appropriate.May ... for the operational planning, feasibility, execution and conduct of clinical trial (s).Serves as the Clinical ...your employment may pose an undue burden to business operations , in which case you may not be offered… more
- Merck & Co. (Rahway, NJ)
- …research activities for innovative statistical methods and applications in clinical trial development.Collaborates in publication of research results ... processing software eg SAS and/or R.-Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-Excellent oral and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol , Good Clinical Practices (GCPs), ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams...evaluating study budgetsCollect information and coordinate with DS Regulatory Operations to post trial information on required… more
- Merck & Co. (Rahway, NJ)
- …in research activities for innovative statistical methods and applications in clinical trial development.-Mentors and guides junior staff in functional ... processing software eg SAS and/or R.-Good understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-Strong oral and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …BICR experience; regularly monitor reviewer metrics for quality control in support of clinical trial endpoint data, and collaborate with Imaging CRO on ... environment required and4 or More Years More than 5 years of experience in imaging operations in oncology clinical development of both early and late phase … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the Study Manager role the Study Associate Manager within Clinical Operations , in adherence to the protocol , Good Clinical Practices (GCPs), ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams...evaluating study budgets.Collect information and coordinate with DS Regulatory Operations to post trial information on required… more
- Catalent (Philadelphia, PA)
- …records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol .Includes review of material status, protocol ... Quality Assurance Document Control manages the communication between the operations /production, project management, shipping and quality assurance groups to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disciplines and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. ... comprehensive Data Management expertise to promote best practices across the Clinical Trial lifecycle.Qualifications: Successful candidates will be able to… more
- Daiichi Sankyo, Inc. (Munich, ND)
- …functional lines including, global regulatory operations , biostatics, data management, clinical science and clinical operations . The Network Lead ... Network Lead will not manage any individual study or trial . The Network Lead: Focuses on managing the entire...assessing potential new FIH sites and in FIH site clinical operations methods required.Experience in site selection… more
