- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Technical Document (CTD), Clinical Study Report (CSR) and Nonclinical Study Report (NCR), electronic Trial Master File (eTMF) and other pivotal documents to ... research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities… more
- Planet Pharma (Waltham, MA)
- …in MS Office (Word, Excel, and PowerPoint) and ability to obtain *Knowledge and master all clinical trial database systems *Ability to successfully complete the ... role (Central or Local), coordinates, oversees and completes functions on assigned trial activities as detailed on the task matrix. *Uses critical thinking to… more
- ICON Clinical Research (Boston, MA)
- …+ Utilizes clinical trial applications including Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and Clinical Trial Management ... As a CLinical Trial Manager you will be joining...study progress, challenges, and opportunities. **You are:** + Bachelor's/ Master 's Degree in Life Science or equivalent. Experience in… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …oversight and management of assigned projects. + Responsible for development and maintenance of Trial Master File (TMF) and regulatory files of assigned ... The Research Project Manager (RPM) is responsible for assigned day-to-day coordination...of activities for assigned clinical trials. Activities include coordinating trial startup and site startup activities, providing training to… more
- Caris Life Sciences (Phoenix, AZ)
- …and process fees through accounts payable. + Oversees creation of new study and site Trial Master File (TMF) entries, including site information and required ... yourself, Caris is where your impact begins.** **Position Summary** A Clinical Trial Specialist provides operational and regulatory support for the Caris sponsored… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + Ensures compliance with the clinical ... eligible to be fully remote is not available._ The ** Manager Clinical Study Lead** (CSL **)** may perform the...masked investigational product, set up and management of unmasked trial master file , review of… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …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
- Deloitte (Dayton, OH)
- Job Title: Manager (Microsoft Identity-Entra ID and Active Directory (AD)) Our Deloitte Cyber team understands the unique challenges and opportunities businesses ... role ends on 8/31/2025. Work you'll do As a Manager , you will be at the front lines with...their Active Directory DR plans and perform regular DR trial runs + Monitoring the health of Active Directory… more
- BeOne Medicines (Emeryville, CA)
- …and site activation plans + Ensures study plans (eg project management plan, monitoring plan, Trial Master File plan, data monitoring plan, ) are created, ... and implemented and ensures training records are well documented and filed + Ensures Trial Master File for study is created, maintained and QC'd on a regular… more
- Kelly Services (West Point, PA)
- …and maintaining project schedule and collaborating with Program Lead + Sets up and maintains Trial Master File (eTMF) + Ensures alignment of budget with ... **Senior Study Manager I** **Therapeutic Areas: Oncology & Immunology** **Description...for the following: + Operational point of contact for trial execution and all trial deliverables +… more
- Cordis (Irvine, CA)
- …associated training documentation is available in the site's investigator file and sponsor trial master file + Contribute to the development and review ... Clinical Research Associate (CRA) reports to the Clinical Monitoring Manager . The CRA is responsible for the initiation, maintenance...met per the Clinical Monitoring Plan + Ensuring the Trial Master File is maintained… more
- Astrix Technology (Boston, MA)
- …+ Oversee study activities, including reviewing monitoring reports and conducting TMF ( Trial Master File ) checks. + Attend status meetings, ... 10-12 years of professional experience, including at least 3 years as a Clinical Trial Manager (CTM) or Clinical Trial Project Manager . + Previous… more
- City of Norfolk, Virginia (Norfolk, VA)
- …are not limited to: Assistant Commonwealth's Attorney I: + Prepares cases for trial by reviewing case reports, identifying the relevant facts of the case, contacting ... conducts transfer and certification hearings. Complies with office policies regarding file documentation after District Court, preparation of documents for Grand… more
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. Biostatistics Sr Manager **What you will do** Let's do this. Let's change the world. In this ... statistical guidance to areas and teams in clinical development, clinical trial biomarker (CTA) and companion diagnostics (CDx) co-development, and precision… more
- BeOne Medicines (San Mateo, CA)
- …Responsible for working with regional and country teams to ensure that country and site level Trial Master File is created, maintained and QC'd on a regular ... on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional study team at internal meetings and at… more
- J&J Family of Companies (Spring House, PA)
- …reviews + Assisting with document processing and management within the electronic master file (ie, vTMF) + Participating in clinical team meetings ... a scholar position, you will work directly with your manager as your start date approaches to confirm your...oncology studies. The GAP Scholar may contribute to Cross-Functional Trial Team (CFTT) activities, including but not limited to… more
- Takeda Pharmaceuticals (Boston, MA)
- …Coordinate maintaining, testing and documentation of programming code and ensure compliance with trial master file requirements. Contribute to the successful ... job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Manager , Data Validation Engineer **POSITION DESCRIPTION** : Takeda Development Center… more
- GRAIL (Menlo Park, CA)
- …that documentation is maintained in a state of constant audit-readiness and filed in the Trial Master File . + Create/review the Data Transfer Plan with ... companies. For more information, please visit grail.com . The Senior Clinical Data Manager (CDM) will lead data management activities for one or multiple diagnostic… more
- Abbott (Alameda, CA)
- …of new study investigators and writing and assembling submissions. + Maintain and audit Trial Master File to ensure inspection readiness. + Perform review ... and accuracy, and escalate issues to the Clinical Operations Manager as needed. + Participate in cross-functional clinical team(s)...required for the conduct of the study (such as Trial Master File (TMF), Clinical… more
- Abbott (Alameda, CA)
- …designing case report forms (CRFs), and training of study sites. + Maintain and audit Trial Master File (TMF) and upload to eTMF to ensure inspection ... Summary** The CRA will ensure quality, accuracy, and integrity of clinical trial data throughout the full lifecycle of multiple clinical trials according to… more
