- Merck & Co. (Rahway, NJ)
- … trial and site-administration and involves preparing, collating, distributing and archiving clinical documents. The- Clinical Trial Coordinator supports ... . And the person collaborates with finance/budgeting-representatives to manage Clinical Trial Research Agreements and payments.Responsibilities include, but… more
- Insmed Incorporated (Bridgewater, NJ)
- …the clinical study team (CST) with the responsibility to manage multiple clinical trials (all phases), and ensure compliance with SOPs, FDA regulations, GCP, ... status updates and TMF metricsParticipates in the review of clinical trial agreements, CRO and vendor contractual...process, including working knowledge of all functional areas of clinical trials and medical terminology, FDA and… more
- Merck & Co. (Rahway, NJ)
- …person is responsible for budget /finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. ... team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operational planning and execution of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible for clinical ... execution of all operational components of a large-scale global clinical program using strong clinical project and...at study start up, and monitor the overall agreed budget against trial progress. Work closely with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... rare diseases and immune disorders. Summary Assist in planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pricing scenarios and strategy for all pipeline products starting in Phase II clinical trials . Generates insights to support G3 decision-making for the NASH ... future access and ARP/rebate guidance and potential financial implications. Leads anchor budget and long term forecast guidance Participates directly in key customer… more
- Catalent (Manassas, VA)
- …health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion ... for inventory build, and proper escalation. Increase spend under contract . Negotiates supply agreements with vendors improving commercial conditions.Responsible for… more
- Insmed Incorporated (Bridgewater, NJ)
- …and applicable ICH guidelines is strongly desired.Experience in drug development, clinical trial methodology. Rare disease experience preferred.Experience in ... executing the safety and risk management activities for one or more clinical development or marketed products throughout their lifecycle. This position reports to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …comprehensive Data Management expertise to promote best practices across the Clinical Trial lifecycle.Qualifications: Successful candidates will be able to ... and other vendors to ensure high quality deliverables on time and within budget to support drug development processes and global submissions. This position provides… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CRO / Vendor Oversight: Manages higher-level negotiations and provides oversight of budget , resources, and timelines for contract research organizations (CROs) ... of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- George Washington University (Washington, DC)
- …and pharmaceutical industry partners for both federal and non-federal clinical trials sponsors. Supports in generating amended contract and/or budget ... Officer. This position's primary responsibility is to oversee the clinical research trial contracting and budget...capture the completion dates and status updates in OnCore Clinical Trials Management System (CTMS). Acts as… more
- Boehringer Ingelheim (Ridgefield, CT)
- …the US site CDA/CTA contract negotiations; for ensuring high quality Clinical Trial Investigator budgets are established within fair market value process; ... and Site Payments group. + Oversees completion of clinical site contract & budget ...and Budget Managers. + Develops and implements Clinical Contracting specific, and trial metrics and… more
- MD Anderson Cancer Center (Houston, TX)
- …information is captured for review and approval of the clinical trial budget . Clinical trial contract invoicing: Analyze industry grants and ... ensures regulatory compliance for the Department of Gastrointestinal Medical Oncology clinical trials , assists with the institutional and federal approval… more
- System One (Pittsburgh, PA)
- Job Title: Remote: Clinical Trial Budget Analyst...contract : $26 an hr Overview: The Office of Clinical Trials (OCT) at our client is ... Financial Support Unit within the office. Responsibilities: + Review clinical trial submissions from study team into...from study team into central office for completeness + Budget building off protocol, or start the budget… more
- Providence (Portland, OR)
- …study team, and sponsor; interact closely with investigators, sponsors, monitors, regulatory/ budget / contract Clinical Research Associates (CRAs), and ... ensure the adherence of study protocol and the compliance of clinical trials to applicable regulations; provide research development support for investigator… more
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Clinical Trials , Billing, Budget and Compliance Specialist Job Profile Title ... in a timely manner. Work with legal to finalize budget and contract . Work with the Billing...financial reports. Prepare any necessary regulatory documentation DUTIES: The Clinical Trials , Billing, Budget and… more
- Allucent (Cary, NC)
- …planning, implementation, tracking, and ensuring the clinical deliverables as per the trial contract , budget , timelines and with quality. In this role ... to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in… more
- Baptist Memorial (Memphis, TN)
- …sponsor representatives. + Using various databases, application systems, and templates, such as clinical trials management systems, trial databases, and EMR ... Summary This Clinical Trials Pipeline Coordinator (CTPC) position...Investigator (PI) and research staff, ie directors, regulatory team, budget and contract specialists, and pharmacy to… more
- Rush University Medical Center (Chicago, IL)
- …accurate coverage analyses with budget overlay in a timely manner. * Review clinical trial protocols and related regulatory documents in order to prepare a ... position will create coverage analyses in accordance with Medicare's Clinical Trial Policy (NCD 310.1) and assist...with the protocol, the informed consent form template, the budget and the contract payment terms. *… more
- ThermoFisher Scientific (Washington, DC)
- …reports on clinical trial operations to leadership + Create and track budget plans for clinical trial operations + Create study materials and quality ... **Job Description** Job Title: ** Clinical Trial Manager** When you're part...site selection and recruitment of prospective investigators for sponsored clinical trials and liaise with the study… more
