- Bristol Myers Squibb (Princeton, NJ)
- …Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent preferred + Additional complex ... language). + Microsoft Suite + Clinical Trial Management System (CTMS) + Electronic Trial Master File System (eTMF) + Document Exchange Portals If you… more
- Ascendis Pharma (Palo Alto, CA)
- …visits. + Review and approve vendor invoices. + Perform periodic review of the electronic Trial Master File (eTMF) + Support safety reporting. + Maintain and ... Responsibilities: + Plan, drive and coordinate operational aspects of clinical trial execution from initiation, planning, execution, maintenance and close-out +… more
- GRAIL (Menlo Park, CA)
- …external communication with site staff and pharmaceutical partners (as applicable). + Ensuring Trial Master File (TMF) is current and maintained + ... The Clinical Trial Manager has overall responsibility to support Clinical Operations . This will include supporting overall day-to-day execution of a clinical … more
- Actalent (Wayne, PA)
- …skills, and the ability to manage multiple tasks efficiently. Hard Skills + Experience with Trial Master File (Veeva, CTMS) + Knowledge of clinical trial ... with regulatory documents, organizing Investigator Meetings, tracking patient visits, maintaining Trial Master Files (TMF), and coordinating payments to clinical… more
- Kelly Services (Rochester, NY)
- …IRB submissions, investigator agreements, informed consent form ICF development, site selection, Trial Master File structure and preparation, and ... all clinical investigations and post-market studies. + Supports CTM and clinical operations in communication with clinical trial sites regarding study conduct,… more
- Actalent (Boston, MA)
- …and develops problem-solving strategies to ensure delivery of quality data + Ensuring that study Trial Master File is maintained and up to date and manages ... Seeking a Senior Clinical Trial Manager to join a growing biotech company...This position will report to the Director of Clinical Operations . Must haves: + Ability to work hybrid in… more
- ThermoFisher Scientific (Wilmington, NC)
- …- Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). - May participate in the ... research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve… 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 ... including contracts, change orders and invoices. + Efficiently establishes and monitors trial milestones as well as overall day-to-day operations of clinical… 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 ... including contracts, change orders and invoices. + Efficiently establish and monitor trial milestones as well as overall day-to-day operations of clinical… more
- Taiho Oncology (Pleasanton, CA)
- …and systems and overseeing study documentation and Trial Master File . The SA supports the Clinical Operations department with developing processes and ... Study Associate I, Clinical Operations Pleasanton, CA, USA Req #368 Wednesday, May...studies and alignment with internal TMF procedures. + Monitors Trial Master File related KPIs… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …/ debugging, deployment, and manages the ongoing operational production operations of analytic dashboards, databases, applications, and integrations supporting ... scheduling / orchestration tools (Tidal Enterprise Schedule or equivalent), enterprise Managed File Transfer tool (Cleo Harmony or equivalent). Must be able to… 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 ... masked investigational product, set up and management of unmasked trial master file , review of...Excel, IVRS/IWRS, EDC + Extensive experience in global clinical trial operations with unique knowledge and skills… more
- University of Rochester (Rochester, NY)
- …the labeling system. (20%) + Document Management: Must accurately execute and file all documentation generated in routine departmental operations . Must ... **Level III** **Level IV** **Level V** Provide quality, timely, consistent clinical trial drug and device packaging in strict compliance to Good Manufacturing… more
- Johns Hopkins University (Baltimore, MD)
- …in a secure location. + To file study-related regulatory/IRB/ethics related documents in the Trial Master File timely. + To maintain a history file ... the Coordinating Center of an NIH sponsored multicenter international clinical trial on inherited retinal degeneration. The Administrative Coordinator will play an… more
- Teva Pharmaceuticals (West Chester, PA)
- …quality and vendor management. The Associate Director is responsible for coordinating GSD Trial Master File (TMF) management and Inspection Readiness ... Associate Director, Business Strategy and Operations , Global Statistical and Data Sciences Date: Jun...to manage resources **Your experience and qualifications** Required: + Master or PhD in statistics, data science, computer science,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …documents to the Daiichi Sankyo Document Control Center (DCC) in support of the Trial master File (TMF). Reconcile the CRO-generated TMF document trackers ... is not limited to the CRO, but includes ancillary vendors (eg translations, trial insurance, and central laboratory). + Work closely and oversee CRO activities for… more
- Actalent (San Diego, CA)
- …staffing changes. Hard Skills + Experience with CRA and CTA management + Proficiency in Trial Master File (TMF) + Experience with Electronic Data Capture ... Sr. Manager Clinical Operations (Oncology) Job Description This role plays a...candidate will manage Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs), ensuring adherence to protocols and regulatory… more
- Abbott (Alameda, CA)
- …meetings, evaluation, selection, and training of new study investigators. + Maintain and audit Trial Master File to ensure inspection readiness. + Perform ... completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed. + Proactively and effectively communicate...required for the conduct of the study (such as Trial Master File (TMF), Clinical… more
- AbbVie (North Chicago, IL)
- …storage, and/or destruction per requirements. + Deposit biomarker related documents to the Trial Master File , ensuring that documentation standards are ... of Lake County, IL. RESPONSIBILITIES: + Manage the biomarker operations and logistics to align with clinical trial...including biomarkers and 2+ years project management, and/or clinical operations experience or Master 's Degree with life… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and resolve risks. + Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents + Participate in preparing job ... **Key Accountabilities** + Create eCRF specifications, design, program, and validate clinical trial setup + Create edit check specifications and program edit checks… more