Senior Manager, Clinical Operations

🔥 20 hours ago

🇺🇸 United States – Remote

💵 $147.3k - $220.9k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

🦅 H1B Visa Sponsor

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👻 Ghost score 9%

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Serve as the Clinical Process Owner for Clinical Operations processes, ensuring governance, accountability, lifecycle management, and alignment across regions and functions • Lead development, review, harmonization, implementation, and maintenance of Clinical Operations SOPs, work instructions, tools, templates, and related documentation • Identify and resolve process gaps, duplication, inconsistencies, conflicting requirements, and unnecessary complexity • Translate regulatory requirements, ICH-GCP principles, quality standards, audit and inspection findings, CAPAs, operational data, and stakeholder feedback into process solutions • Lead and represent cross-functional process governance and decision-making with Clinical Operations, Quality Assurance, Regulatory, Project Management, Data Management, Biostatistics, Medical, Training, and other functions • Lead process implementation and change management, including impact assessment, stakeholder engagement, training, communication, adoption monitoring, and effectiveness evaluation • Serve as a senior Clinical Operations SME for strategic initiatives, audits, inspections, CAPAs, process assessments, operational improvements, and business development support • Provide Clinical Operations input for proposals, budgets, contracts, and bid defense meetings • Represent Clinical Operations process capabilities, delivery models, and operational strengths to prospective clients • Potentially lead cross-functional working groups, process teams, and strategic improvement initiatives

🎯 Requirements

• Bachelor’s degree in life sciences, healthcare, clinical research, business, or a related field; equivalent experience may be considered • 5+ years of progressive clinical research or clinical operations experience in a CRO, pharmaceutical, biotechnology, or global clinical outsourcing environment • Proven experience leading complex cross-functional or global process improvement initiatives from assessment and design through implementation and effectiveness evaluation • Strong knowledge of clinical trial operations, clinical monitoring, site management, and cross-functional trial delivery processes • Strong knowledge of ICH-GCP, regulatory expectations, quality standards, and inspection readiness principles • Demonstrated ability to influence stakeholders, facilitate decisions, resolve conflicting requirements, and drive outcomes in a matrix organization • Preferred: experience owning or leading Clinical Operations SOPs, work instructions, and controlled documentation • Preferred: experience with process mapping, change management, Lean, or continuous improvement methodologies • Preferred: expert understanding of Clinical Operations processes and cross-functional interfaces • Preferred: ability to interpret regulatory and quality requirements and translate them into practical processes

🏖️ Benefits

• Discretionary annual bonus • Health insurance • Retirement savings benefits • Life insurance • Disability benefits • Parental leave • Paid time off for sick leave and vacation