Senior Clinical Site Manager, Oncology

$140,000 - $165,000/Yr

Astellas Pharma - Northbrook, IL

Full-time - Mid Level

Hybrid - Northbrook, IL

Management of Companies and Enterprises

About the position

The Senior Clinical Site Manager, Oncology at Astellas Pharma Inc. serves as the primary contact between the Sponsor and Investigational Sites, ensuring compliance with clinical trial protocols and regulations. This role involves managing site relationships, overseeing trial activities, and ensuring inspection readiness from study start-up to site closure. The position requires collaboration with various stakeholders to facilitate effective site management and trial execution.

Responsibilities

• Acts as primary local company contact for assigned sites for specific trials.
• Develops meaningful site relationships through consistent collaborative communication and engagement.
• May participate in site feasibility and/or pre-trial site assessment visits.
• Attends/participates in investigator meetings as needed.
• May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study.
• Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring, site management, and site/study close-out according to SOPs and policies.
• Ensures site staff are trained and the corresponding training records are complete and accurate.
• Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
• Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
• Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.

Requirements

• BA/BS degree with ≥5 years of experience in pharmaceutical related drug development or direct equivalent experience.
• 5+ years site monitoring and/or site management experience.
• A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience.
• Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Strong critical thinking and problem-solving skills.
• Strong IT skills in appropriate software and company systems.
• Willingness to travel up to 40% with overnight stay away from home.
• Proficient in speaking and writing English.

Nice-to-haves

• Experience working cross-functionally and in matrix teams
• Experience in executing Lead CSM role
• Experience mentoring more junior site monitors or site managers
• Experience working in early development studies

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program
• Fleet Car