Clinical manager h1.location_city

Join Sumitomo Pharma Co., Ltd., a leading global pharmaceutical company committed to enhancing patient care across various therapeutic areas, including oncology. We are focused on accelerating the discovery and development of innovative therapies designed to improve health outcomes. Learn more about our mission and values on our website or connect with us on LinkedIn.

As a Lead Clinical Research Manager, you will play a vital role in supervising the daily operations of our Site Monitoring Team, ensuring that they achieve project objectives while fully complying with GCP/ICH guidelines and regulatory requirements.

Your responsibilities will include working collaboratively with both internal and external stakeholders to ensure timely completion of study deliverables within budgetary constraints. You will manage clinical site operations under the guidance of the Lead Clinical Research Associate (CRA) and site monitors.

Key Responsibilities:

• Support the Director of Clinical Operations in the management of the Site Monitoring Team, including approvals for timesheets and expenses.
• Assist in forecasting budgets for site monitoring across various clinical programs.
• Implement global initiatives aimed at standardizing monitoring training and practices.
• Collaborate with cross-functional study teams to coordinate activities related to monitoring.
• Coordinate clinical study timelines with project leaders to meet critical milestones and proactively address potential monitoring-related issues.
• Provide oversight by reviewing monitoring schedules, metrics, and reports.
• Review monitoring visit reports and work with site monitors to identify trends and resolve quality or site-related challenges.
• Contribute to the development and evaluation of study plans and essential documents.
• Establish systems and standards to ensure quality assurance at investigative sites, vendors, and within data management.
• Oversee the collection and organization of monitoring-related site-level Trial Master File (TMF) documents to ensure inspection readiness.
• Contribute to study feasibility assessments and assist in selecting countries and sites for studies.
• Work with the Lead CRA to develop and potentially lead monitoring training sessions.
• Mentor junior team members and perform other responsibilities as assigned.

Professional Experience/Qualifications:

• A minimum of 6 years of CRA experience in the pharmaceutical or biotech industry.
• Bachelor's Degree required.
• Strong understanding of ICH/GCP guidelines and the drug development process; oncology experience is preferred.
• Excellent interpersonal, communication, and leadership skills.
• Proficiency in MS Office Suite with strong organizational capabilities.
• Proven ability to work independently in a matrix environment while managing multiple tasks effectively.
• Adaptability to adjust priorities and project needs as they arise.

This position does not require on-site monitoring but may involve travel. The base salary range for this role is $137,800 to $172,300, with the potential for merit-based salary increases and a comprehensive benefits package, including medical, dental, vision, life insurance, and more. Our time-off policy includes flexible paid time off, holidays, and sick leave.

Compliance: Ensure all activities adhere to applicable regulatory, legal, and operational standards while conducting business ethically.

Mental/Physical Requirements: This role requires the ability to navigate a fast-paced environment, managing multiple demands effectively and exercising sound judgment.

Equal Employment Opportunity: Sumitomo Pharma America is an equal opportunity employer, welcoming applicants regardless of race, color, religion, national origin, age, sex, gender identity, sexual orientation, disability, or veteran status.

If you require assistance during the application process, please reach out for accommodations.