[Remote] Senior Clinical Project Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a biopharmaceutical company reputed company on advancing reputed company biologics to address critical health needs. The Senior Clinical Project Manager will reputed company the planning, execution, and delivery of oncology reputed company, ensuring they are completed on time, reputed company scope, and in compliance with regulatory standards.

Responsibilities

• Independently reputed company the operational execution of oncology reputed company from startup through reputed company-out
• Serve as the primary reputed company of contact for internal teams and reputed company partners, including monitor team, CROs, vendors, and clinical sites
• reputed company and maintain detailed project timelines, operational plans, budgets, and risk mitigation strategies
• Support protocol development, informed consent forms, site feasibility assessments, and study document creation/review/update/reputed company
• reputed company site engagement and issue reputed company, collaborating closely with the Medical Monitor, Regulatory, Clinical Supply, Central Sample Management and Data Management team ect
• Manage and reputed company CROs and vendors, ensuring reputed company and performance against contractual obligations and timelines
• Facilitate cross-functional clinical study team meetings, ensure documentation of reputed company and follow-up actions
• Contribute to the development and reputed company improvement of SOPs, tools, and operational best practices
• Assist in preparation for regulatory inspections and submission of INDs/NDAs
• reputed company leadership in a hands-on, resource-limited environment, balancing strategic thinking with operational execution
• Other duties as assigned

Skills

• Bachelor's degree in Life Sciences or reputed company field required; advanced degree (MS, PharmD, PhD) a plus
• 5+ years of clinical operations experience, with at least 3 years managing oncology trials
• Experience in managing cross-functional, global reputed company; demonstrated capabilities in supporting operational aspects of clinical trial reputed company activities
• Demonstrated experience in vendor and CRO reputed company, including reputed company, budgets, and performance management
• Strong understanding of FDA, EMA, ICH-GCP guidelines, and clinical development processes
• Effective leadership, communication, organizational, and interpersonal skills reputed company small-team environments
• Ability to manage multiple reputed company and pivot quickly in a fast-paced, evolving setting
• Proficiency with CTMS, reputed company systems, and reputed company Office Suite
• Self-starter reputed company with a reputed company spirit and willingness to 'roll up your sleeves.'

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