- Novartis Group Companies (East Hanover, NJ)
- …management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, ... Job Description Summary Title: TMF Integration Oversight Manager The ideal location for this role is...(domestic and/or international) will be defined by the hiring manager . This position will require limited travel. Clinical Document… more
- Parexel (Trenton, NJ)
- …documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow ... with the set-up, running and close-out of sites in a clinical trial . **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** +… 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
- 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
- Sumitomo Pharma (Trenton, NJ)
- …organizational policies and procedures **Key Core Competencies** + Demonstrated understanding of Trial Master File structure and TMF systems + Experienced ... compliance. **Job Duties and Responsibilities** + Conducts periodic quality reviews of study Trial Master Files to ensure quality, completeness and timeliness. +… 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
- 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
