Master File (TMF) in alignment with Genmab’s procedural documents, ICH-GCP guidelines, and regulatory authority expectations... is to ensure TMF inspection readiness and to assist the Director, TMF Team Lead with tactical implementation strategies related...
. Join Gilead and help create possible, together. Job Description KEY RESPONSIBILITIES: Senior Manager, Global Clinical Supply... (CSR) and trial master file (TMF). Maintains compliance with required training. Digital Systems IVRS support: serves...
. Join Gilead and help create possible, together. Job Description KEY RESPONSIBILITIES: Senior Manager, Global Clinical Supply... for clinical study reports (CSR) and trial master file (TMF). · Maintains compliance with required training. Digital Systems...
Position Overview Bicara Therapeutics is seeking a Manager - Senior Manager of Clinical Supply Chain to lead clinical... will report directly to the Senior Director, Supply Chain and will be responsible for ensuring that our investigational therapy...
development, training and oversight, and execution or support of projects within the TMF function. The Senior Manager, Document...The Senior Manager, Document Management is a leadership role that supports the Document Management department...
This role is an onsite position in one of our office locations. Fully remote is not eligible. The Senior Clinical... of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL...
and audits as requested. Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents... experience as a Lead Clinical Data Manager with substantial RAVE experience. Bachelor's Degree in a science, health related...
Manager, Clinical Quality Site Oversight Lead will partner and support the Alnylam CDO to ensure quality and compliance... Site File (ISF) KQIs, ensuring compliance and readiness. Partner with TMF team to drive corrective/preventive actions...
with serious adverse event reporting requirements. Update CTMS/e-TMF/Tracking System and report to Project Manager. Assist in preparing...Position: Senior Clinical Research Associate FLSA Status: Exempt Location: Remote (East Coast USA Preferred...
environment. In a CRA role, you'll receive extensive support through regulatory submissions, TMF management, and in-house CRAs... for projects with heavy site management needs. Through regular touchpoints and coaching conversations with your Line Manager...
role, you'll receive extensive support through regulatory submissions, TMF management, and in-house CRAs for projects... with heavy site management needs. Through regular touchpoints and coaching conversations with your Line Manager, we ensure...
role, you'll receive extensive support through regulatory submissions, TMF management, and in-house CRAs for projects... with heavy site management needs. Through regular touchpoints and coaching conversations with your Line Manager, we ensure...
role, you'll receive extensive support through regulatory submissions, TMF management, and in-house CRAs for projects... with heavy site management needs. Through regular touchpoints and coaching conversations with your Line Manager, we ensure...
role, you'll receive extensive support through regulatory submissions, TMF management, and in-house CRAs for projects... with heavy site management needs. Through regular touchpoints and coaching conversations with your Line Manager, we ensure...
role, you'll receive extensive support through regulatory submissions, TMF management, and in-house CRAs for projects... with heavy site management needs. Through regular touchpoints and coaching conversations with your Line Manager, we ensure...
, status, retrieval of such documents as protocol, IB, etc.) ·Support Clinical Project Manager and Clinical Research... will maintain site contact lists, trackers, etc. ·Support the Clinical Project Manager for review of invoices. ·Generate mass...
Clinical Program Manager (CPM) W2 Contract-to-Hire Salary Range: $187,200 - $208,000 per year Location: Redwood... City, CA - Hybrid Role Job Summary: This is a unique opportunity for a Clinical Program Manager (CPM...
The Regulatory Compliance manager is responsible for managing the regulatory operations supporting cardiovascular... documents and Trial Master Files (TMF/eTMF) for audit readiness. Serve as the institutional point of contact for IND/IDE...
Company Description The Medicus Firm (TMF), a part of M3USA, is a national healthcare recruitment firm with a mission... recruitment companies in the US, TMF focuses on providing the most efficient and effective recruiting services to hospitals...
Clinical Program Manager (CPM) W2 Contract-to-Hire Salary Range: $187,200 - $208,000 per year Location: Redwood... City, CA - Hybrid Role Job Summary: This is a unique opportunity for a Clinical Program Manager (CPM...