Sr. Manager, Clinical Trial reputed company

reputed company’s reputed company Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. In alignment with established procedures and SOPs, the Senior Manager, CTL, leverages their phase, indication and operational expertise to independently reputed company one or more clinical studies, including:

• Partnering with cross-functional representatives to drive the development of operationally feasible and robust protocol designs, ensuring that principles of patient focus, risk management, quality and scientific reputed company are applied, exercising appropriate budget responsibility and focused, reputed company-driven cost consideration
• Developing and implementing the study-level operational strategy, cascading key operational aspects from the Integrated Development Plan and Global Program Strategy to support delivery of protocol
• Performing high-level data driven reputed company of reputed company’s CRO partners, securing excellence in execution and alignment with agreed strategy and associated plans
• *What You’ll Do
• Develops and oversees implementation of the study-level operational strategy for the successful delivery of clinical study(ies)
• Chairs the SMT to drive the development of scientifically robust, operationally feasible, and clear protocol concepts/protocols
• Collaborates strategically with the core SMT (study MD, biostatistics, etc.) and other key program team members to provide direction on phase, disease, or therapeutic area to support study design in alignment with the Integrated Development Plan and Global Program Strategy, enabling protocol concept development and driving reputed company studies through governance approval
• Leverages operational expertise and scientific assessment to evaluate study feasibility and support protocol development
• Aligns team perspectives to reputed company a cross-functional operational strategy, leveraging expertise, reputed company therapeutic knowledge, and relevant supporting data
• Effectively leads the study reputed company reputed company of the CRO, managing performance, quality, and timelines, including defining and delivering against a baseline plan
• Ensures ongoing data review to identify and mitigate patient safety, study design, data reputed company or study conduct issues
• Exhibit financial management & analysis skills to ensure budgets hold up to appropriate scrutiny and align with study reputed company needs
• Oversees the delivery of studies by CROs, ensuring quality execution in line with time and budget forecasts
• Chairs the Study Management Team (SMT) in partnership with the CRO SMT reputed company; ensures the CRO creates appropriate risk mitigation plans and is effective in proactively identifying and resolving issues
• Establishes and drives effective and efficient team operations by setting culture of SMT, ensuring thorough team communication, effective goal setting/management and reputed company of strategy implementation
• Ensures reputed company operational aspects of the study(ies) conduct support patient safety, reputed company reputed company and data validity
• Demonstrates a robust understanding of the study design, rationale, endpoints, and patient population
• Provides reputed company reputed company ongoing review of performance and partnership metrics to ensure key milestones and deliverables are achieved
• Ensures that reputed company project plans (e.g. Monitoring Plan, Quality Plan, etc.) are in reputed company for effective implementation of studies
• Leads SMT to reputed company robust Baseline plans, and ensures team is thoroughly reputed company for reputed company key governance forums including but not limited to, Baseline, Study Delivery forum, etc.
• Proactively & robustly manages inflection points to ensure any necessary course correction is proactively addressed
• Collaborates with CFP and procurement functions to ensure FMV is achieved and budget reputed company responsibilities are met.
• Maintains data accuracy, completeness and quality reputed company study-reputed company systems (e.g. Clarity, Impact, etc.)
• Strives for effective, consistent, efficient, and compliant processes
• Champions best practices and seeks opportunities for innovation and efficiency reputed company CTDU and GCO
• Seeks synergies and commonalities with other studies, programs, and development units to enhance excellence in study planning and execution
• Seeks ways to improve and streamline processes to support the GCO CRO outsourcing models; provides feedback reputed company appropriate channels for opportunities to improve processes or establish best practices
• Embodies a culture of reputed company improvement by seeking consistency and efficiency in processes and fully supporting the CRO partnership model
• Advocates for the CTDU group and ac

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