Lead TMF activities for clinical trials across start-up, maintenance, close-out, and archive phases.
Oversee eTMF health, quality issue workflows, and compliance with regulatory standards.
Support TMF document processing, audits, and continuous improvement initiatives.
Akero Therapeutics is a clinical stage biopharmaceutical company focused on developing transformational treatments for serious metabolic diseases such as MASH. They are part of Novo Nordisk and foster a collaborative culture with diverse skill sets.
Oversee clinical operations for a project at a regional/global level, ensuring compliance with protocols and regulations.
Act as primary liaison between CRAs and clinical project team, providing training, oversight, and assessment.
Manage site performance, develop study tools, and support enrollment strategies to meet project timelines.
Alimentiv provides clinical services for global clinical trials, specializing in study delivery and monitoring. The company emphasizes quality, compliance, and professional growth, with a team of experienced professionals.
Provide strategic oversight and leadership for a portfolio of complex global clinical trials in dermatology and rheumatology.
Serve as the key client contact, ensuring alignment on objectives, communication, and satisfaction throughout the study lifecycle.
Monitor budgets, timelines, risks, and quality while mentoring project managers and driving operational improvements.
The company is a specialized Contract Research Organization (CRO) focused on dermatology and rheumatology clinical trials. It fosters an international, collaborative, and science-driven environment with a commitment to operational excellence and innovation.
Perform in-house and remote monitoring activities for clinical trials, ensuring compliance with regulatory requirements and study protocols.
Support study start-up, site selection, and document tracking while assisting CRAs with on-site and remote monitoring.
Communicate with investigative sites to resolve queries and maintain study tracking tools for deviations, SAEs, and data discrepancies.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. The environment is collaborative, international, and focused on improving patient outcomes through high-quality research.
Manage and deliver full clinical site monitoring services for complex multinational projects, ensuring compliance with SOPs, study guidelines, and GCP best practices.
Act as Lead CRA, serving as primary liaison between CRAs and project teams, and participate in development of monitoring plans, protocols, and tools.
Identify and recruit site investigators, oversee investigational site monitoring, and ensure site staff are compliant with training requirements.
Alimentiv is a clinical research organization providing monitoring and site management services for clinical trials. They are a full-time, permanent employer with a focus on building collaborative relationships and maintaining high standards in clinical study delivery.