Katalyst Healthcares and Life Sciences
Project Manager - Clinical R&D
Katalyst Healthcares and Life Sciences, Jersey City, New Jersey, United States, 07390
Roles & Responsibilities:
CLINICAL R&D Experience is a must. AI experience is a plus! Clinical R&D Background: Experience of working in a Clinical R&D organization or a division of a large pharma company. Support implementation of systems used in pharmaceutical R&D, such as regulatory information management or quality management systems. Demonstrate knowledge of clinical data flow, data architecture, and data mapping. Identify opportunities for process automation and AI adoption within clinical R&D workflows. clinical trials, including patient recruitment, trial design, data management, monitoring, R&D Pipeline management, regulatory submission etc (at least a few of them) Project Leadership and Management: Lead the planning, execution of clinical research projects. Define project scope, goals, schedules, and resource allocation. Manage project budgets, timelines, risks, and ensure deliverables meet quality standards. Oversee cross-functional teams, potentially including data scientists, engineers, clinicians, and regulatory specialists. Communication and Collaboration: Act as a liaison between technical teams and business stakeholders, ensuring clear communication and alignment. Communicate effectively with internal teams, external vendors, and clinical sites. Present project updates and strategic recommendations to senior management and clients.
CLINICAL R&D Experience is a must. AI experience is a plus! Clinical R&D Background: Experience of working in a Clinical R&D organization or a division of a large pharma company. Support implementation of systems used in pharmaceutical R&D, such as regulatory information management or quality management systems. Demonstrate knowledge of clinical data flow, data architecture, and data mapping. Identify opportunities for process automation and AI adoption within clinical R&D workflows. clinical trials, including patient recruitment, trial design, data management, monitoring, R&D Pipeline management, regulatory submission etc (at least a few of them) Project Leadership and Management: Lead the planning, execution of clinical research projects. Define project scope, goals, schedules, and resource allocation. Manage project budgets, timelines, risks, and ensure deliverables meet quality standards. Oversee cross-functional teams, potentially including data scientists, engineers, clinicians, and regulatory specialists. Communication and Collaboration: Act as a liaison between technical teams and business stakeholders, ensuring clear communication and alignment. Communicate effectively with internal teams, external vendors, and clinical sites. Present project updates and strategic recommendations to senior management and clients.