- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in dialogue with inspector(s) to address study inquiries throughout course of HA inspection-Ensure trial master file is complete and accurate for assigned ... and extended clinical study team in end-to end delivery of the clinical trial with consistency, quality and per planned timelines. The SDL has the accountability… more
- Actalent (Jersey City, NJ)
- The Manager , TMF Operations role ensures a complete, accurate, and high-quality Trial Master File (TMF) as the subject matter expert through proper, ... Completeness Reviews to maintain an inspection readiness state throughout the clinical trial . + Facilitate the planning and execution of periodic TMF content… more
- ThermoFisher Scientific (Bridgewater, NJ)
- …responsibilities and tasks:** **Be responsible for setting-up, monitoring verifying and archiving the clinical Trial Master File (TMF)** + In charge of the ... and EU) + Responsible for ensuring study documentation (including trial master files, study related contracts and...activity + When needed, liaise with the Local Transparency Manager (LTM) or the Global Transparency Manager … more
- Actalent (New York, NY)
- …and third-party payments. + Ensure required study documents are submitted to the CRO-held electronic Trial Master File (eTMF). + Assist the CPM with Sponsor ... The Clinical Trial Associate (CTA) will play a vital role...Responsibilities + Generate agendas and minutes, maintain study tracking, file and conduct quality reviews, and participate in process… more
- Taiho Oncology (Princeton, NJ)
- …study closeout related activities and trial completion. + Overall responsible for the Trial Master File , including review of the TMF plan, related ... global studies to support the Clinical Development Plan. The Senior Study Manager (SSM) is responsible for ensuring assigned clinical studies are delivered within… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + Ensures compliance with the clinical ... to, assisting with masked investigational product, set up and management of unmasked trial master file , review of unmasked data in the electronic data… more
- Mount Sinai Health System (New York, NY)
- …event documentation, safety reporting, and correspondence with IRBs and sponsors. + Maintain the Trial Master File (TMF) and site investigator files in ... **Job Description** The **Clinical Trial Manager ** provides leadership and oversight...related scientific/health field (life sciences, health administration, etc) required. Master 's degree or equivalent advanced training in clinical research… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …limited to, providing statistical consultation on clinical development plans, clinical trial design and clinical study endpoints, calculating sample size, authoring ... team members and cross-functional partners. Provides statistical consultation on trial design and study endpoints and authors statistical analysis plans.… more
- Taiho Oncology (Princeton, NJ)
- …globally, assisting, updating of study trackers and systems and overseeing study documentation and Trial Master File . The SA supports the Clinical Operations ... Coordinates cross functional study team meetings and supports study manager with meeting minutes for assigned studies. + Updates...studies and alignment with internal TMF procedures. + Monitors Trial Master File related KPIs… more
- MTA (New York, NY)
- Manager General & Technical Accounting - B&T Job...B&T and Central Business District Tolling (CBD), and the Trial balance for B&T and CBD is accurate. + ... Accting Date Posted: Sep 11, 2025 Description JOB TITLE: Manager General & Technical Accounting - B&T DEPT/DIV: Controller...related work experience. The F ollowing is/are preferred: + Master 's degree in Accounting , Business, or Finance. +… more
- Sanofi Group (Morristown, NJ)
- …review for safety data and statistical surveillance for efficacy data, ) + Ensure trial master file documents readiness and availability, and mandatory ... Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence results +… more
