- Insmed Incorporated (NJ)
- …and globally.This role can be hybrid or remote.What You'll Do: Primary operational lead over an 1-2 indications within one compound, in collaboration with the ... Senior Director, Clinical Operations. Ensures consistent and successful execution...and procedures. Ensure compliance with all Company/Regulatory requirements & TMF quality standards.Work with outsourcing/procurement management to optimize the… more
- CSL Behring (King Of Prussia, PA)
- …committed to developing therapies that make a meaningful difference worldwide. Could you be our next Senior TMF Lead ? The job is in our King of Prussia PA, ... documentation across clinical programs. Operating within a matrixed environment, the Senior TMF Lead collaborates with internal teams and external partners… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …position in one of our office locations. Fully remote is not eligible._ The ** Senior Clinical Study Lead ** (CSL) is expected to operate with high-degree of ... study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study...to Clinical Trial Management System (CTMS), Trial Master File ( TMF ) etc. + Ensures compliance with the clinical trial… more
- Fiserv (Minneapolis, MN)
- …an impact on a global scale, come make a difference at Fiserv. **Job Title** Senior NonStop Systems Engineer **About your role:** In this critical role you will ... Lead Guardian OS, Network, and other major software release...knowledge of Guardian operating system, system utilities (TACL, MEASURE, TMF ), and NonStop software and utilities + Experience with… more
- BeOne Medicines (San Mateo, CA)
- …Depot performance management in AMER regions. + Work with Supply Chain Lead and depot PM setting up distribution and return/destruction procedures for studies ... and executed disposition reports are archived and uploaded onto e- TMF accurately and timely. + Well manage the depot...brings compliance issues to the attention of management. + Lead and measure processes to ensure logistics operations are… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …of office locations. This role is NOT eligible to be fully remote._ The ** Senior Manager** **SSU Business Services** will play a pivotal role in supporting the Site ... to ensure efficiency and effectiveness **Leadership & Team Collaboration:** + Lead and support meetings, sending meeting invites, setting agenda, creating minutes,… more
- Lilly (Boston, MA)
- …Trial Master File ( TMF ) by performing periodic QC reviews to ensure the TMF is always "inspection ready". + Lead , mentor, and develop a high-performing team ... clinical studies, managing CROs and vendors to ensure high-quality execution. + Lead internal clinical trial team meetings, tracking key study metrics (eg,… more
- BeOne Medicines (Emeryville, CA)
- …the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the regional ... QC'd on a regular basis as per the study TMF QC plan + Provides input to Global Clinical...experience in clinical research including relevant experience as team lead in clinicial functions + Experience as CRA is… more
- Gilead Sciences, Inc. (Foster City, CA)
- …by advancing the care of patients with life-threatening diseases. **KEY RESPONSIBILITIES:** Senior Manager, Global Clinical Supply Chain is a leader that who carries ... supply deliverables for clinical study reports (CSR) and trial master file ( TMF ). + Maintains compliance with required training. **Digital Systems** + IVRS support:… more
