- Merck & Co. (Rahway, NJ)
- …talented and dedicated colleagues while developing and expanding your career.The Senior Trial Initiation Specialist in Global Site Budgets and Payments will be ... Market Value based upon protocol design, industry benchmark data and clinical trial team feedback.Represent Global Site Budgets and Payments on Clinical Trial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to comply ... WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's compliance with… more
- Aequor (Los Angeles, CA)
- …Length of Assignment13-weeks Nursing Specialty ODR -Felony Incompetent to Stand Trial (FIST) Program Mandatory Certification All required prior to assignment start ... will be working on the Felony Incompetent to Stand Trial (FIST) Diversion and Community Based Restoration program. This...felony charges, and who are found incompetent to stand trial , out of jail and into community-based settings. Individuals… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a difference? The Position Provides tactical leadership to staff, within the Trial Management (TM) function of North America Clinical Operations (NACO). Takes ... aligned with the planning & successful delivery of studies within the clinical trial portfolio. Relationships Reports to a Senior Manager (or above) within North… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and quality plans, ... and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and quality.Establish strong partnership with Functional and Regional… more
- Novo Nordisk Inc. (WA)
- …goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex improvement/innovation projects ... and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with multiple… more
- Merck & Co. (North Wales, PA)
- …heavily relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections, Trial ... used to ensure the right data is collected from trial participants, in the right way to enable the...support drug applications and regulatory submissions to health authorities globally. Trial Data Management (TDM) is a core business capability… more
- Merck & Co. (Rahway, NJ)
- …(POC) for assigned protocols and link between Country Operations-and clinical trial team (CTT).Responsible for project management of the assigned studies: ... country roles ensuring a strong collaboration (including the CTC Clinical Trial Coordinator, CRAs and-COM Clinical Operations Manager).-Responsible for creating and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …brochures (IB) Informed consent and assent forms Lay summaries of clinical trial results Clinical evaluation plans (CEP) and clinical evaluation reports (CER) ... meetings, drives discussions, and ensures decisions are taken concerning project/ trial -specific medical writing issues Resolves document content issues and questions… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility assessment from a ... achieve the Target Product Profile (TPP)- Development of clinical sections of trial -level regulatory documents (eg, response to HAs, briefing book, etc.) in… more
- Merck & Co. (Rahway, NJ)
- …sustained. The Sr CCQM Lead supports large to medium size country/cluster clinical trial operations to achieve those objectives. -Under the guidance of the Regional ... and/or line management position.Deep knowledge and understanding of Clinical Trial processes, GCP and applicable clinical research-related regulations.Solid track… more
- Merck & Co. (Billings, MT)
- …CFIA and USDA regulatory policies.- The position will require developing research trial protocols, trial monitoring, and summarizing clinical and marketing ... with product evaluation, licensing trials, and product development.- Perform field trial evaluation of newly licensed products to offer technical support information… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRO scope of work in collaboration with Outsourcing Procurement Management.Lead trial feasibility and site identification activities in collaboration with the CRO ... and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRO scope of work in collaboration with Outsourcing Procurement Management.Lead trial feasibility and site identification activities in collaboration with the CRO ... and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, Operations Program Lead,… more
- Merck & Co. (North Wales, PA)
- …ResponsibilitiesResponsible for the operational planning, feasibility, and execution of a clinical trial .May serve as the clinical trial team leadMay lead team ... planning, development, and execution elements (eg, data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates,… more
- Tris Pharma (Monmouth Junction, NJ)
- …products, liaising with key opinion leaders (KOLs), clinical trial investigators and internal scientific, pharmacology and regulatory teamsReviews ... working closely with local functions on the full clinical trial life cycle; Reviews, synthesizes and analyses clinical ...trial life cycle; Reviews, synthesizes and analyses clinical trial data and translates data into actionable plans at… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …assets and the enterprise as well as providing strategic input into clinical trial strategy and regulatory development. With a holistic overview across the pipeline ... Strategic Input: Provide strategic input into early-stage pipeline clinical trial activities ensuring alignment with regulatory requirements and commercialization… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.Clinical trial protocol development and ... reviews (clinical trial protocols and medical device protocols)ICF reviews to ensure adequate disclosure for collection, retention, testing and retesting of samples Project Team Participation: Provide device-specific regulatory insight/guidance during CDx… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Metrics:-When needed, help support the partnership with Clinical Trial Business Operations (CTBO)to:-monitor GCO processes and workstream implementations ... of 5 years' experience in pharmaceutical or biotechnology across clinical trial operations. Experience in training, process improvement, and project management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Oversees typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares ... guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents… more
