Seeking a detail-oriented TMF Manager at Jazz Pharmaceuticals to develop and execute a strategic TMF operations plan. Collaborate with cross-functional teams, drive TMF process improvements, and ensure regulatory compliance. Ideal candidates possess ...
Responsible for overseeing Trial Master Files, managing document receipt/review, compliance with SOPs, and keeping records audit-ready. Assist in patient recruitment, monitor CROs, review visit reports, and ensure GCP compliance. Collaborate with Cli...
Lead the management of Trial Master Files for BioNTech clinical trials, ensuring compliance with guidelines and regulations. Evaluate and maintain TMF quality, oversee document completeness and accuracy, and collaborate with teams. Drive excellence i...
Mirum Pharmaceuticals seeks an Associate Director to lead eTMF Management, ensuring quality oversight of clinical document systems. Spearheading TMF transformation, this role involves implementing new processes, managing records, overseeing staff and...
Alpine Immune Sciences seeks an Associate Director-Clinical Documents (eTMF) to lead operational oversight of the trial master file system. Responsibilities include strategy development, document quality control, staff training, and regulatory compli...
Seeking a TMF/CTMS Specialist to support Veeva systems, ensuring compliance with regulations and guidelines. Responsible for UAT, SOP adherence, QC processes, and user training. Requires 3+ years in clinical ops and proficiency in Veeva TMF/CTMS, FDA...
Lead the TMF Program for Pharmalex's Professional Services team. Manage Study Resources to ensure high-quality Trial Master Files with a focus on inspection readiness. Remote role with flexible hours. Expertise in TMF, eTMF systems, clinical trials, ...
Join Ascendis, a prominent biopharma leader revolutionizing Endocrinology Rare Disease, Oncology, and Ophthalmology. With TransCon® innovation, we prioritize patient impact. Seeking a meticulous Clinical Operations Specialist with a BSc and 3 years' ...
Join bluebird bio in pursuing curative gene therapies for patients and families. As the eTMF Manager, oversee document maintenance, ensuring adherence to regulations. Lead eTMF kick-off meetings, drive system improvements, and ensure inspection readi...
Seeking Senior TMF Consultant responsible for managing Trial Master Files per GCP guidelines. Duties include reviewing, archiving regulatory documents, ensuring TMF readiness for audits, and collaborating with study teams. Requires 4-6 years of clini...
