Clinical Site Manager - Oncology - SE (Field based) at Astellas Pharma

Unclassified - Northbrook, IL

Full-time - Mid Level

Hybrid - Northbrook, IL

About the position

The Clinical Site Manager (CSM) plays a crucial role in the management of clinical trials, serving as the primary contact point between the Sponsor and the Investigational Site. This position is essential for ensuring that trial sites are inspection-ready and compliant with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations from the start of the study through to site closure. The CSM is responsible for managing the site/sponsor relationship, ensuring effective communication and support throughout the clinical trial process. In this role, the CSM will collaborate closely with various stakeholders, including the Clinical Trial Lead (CTL), Clinical Trial Manager (CTM), Clinical Trial Specialist (CTS), and Study Start-Up Specialist (SSS), to ensure comprehensive site management and the successful execution of trial-related activities. Responsibilities include site selection, pre-trial assessments, recruitment and retention strategies for study participants, site activation and initiation, on-site and remote monitoring, and overall relationship management with the site. The CSM will also be involved in close-out activities, ensuring that all aspects of the trial are completed in accordance with regulatory requirements and company policies. The CSM is expected to develop meaningful relationships with site staff through consistent communication and engagement, participate in investigator meetings, and may serve as the Lead CSM for specific studies, providing oversight and support to other CSMs. This role requires a proactive approach to site management, including the implementation of risk-based monitoring strategies, ensuring site compliance with study protocols, and maintaining accurate and complete documentation throughout the trial phases. The CSM will also be responsible for training site staff and ensuring that all necessary supplies and documentation are in place for the successful conduct of the trial.

Responsibilities

• Serve as the primary local company contact for assigned sites for specific trials.
• Develop meaningful site relationships through consistent collaborative communication and engagement.
• Participate in site feasibility and/or pre-trial site assessment visits.
• Attend/participate 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.
• Drive 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.
• Implement risk-based monitoring approaches at the site level and ensure timely resolution of issues found during monitoring visits.
• Ensure site staff are trained and maintain complete and accurate training records during all trial phases.
• Collaborate closely with the study team during the site activation phase to expedite the process.
• Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
• Oversee site level recruitment strategy and implementation in partnership with other functional areas.
• Ensure clinical drug supplies are appropriately used, handled, and stored, and returns are accurately inventoried.
• Maintain complete, accurate, and timely data and essential documents in relevant systems used for trial management.
• Document trial-related activities, including writing visit reports and follow-up letters in accordance with SOPs.
• Communicate relevant status information and issues to appropriate stakeholders promptly.
• Review study files for completeness and ensure archiving retention requirements are met.
• Act as a local expert in assigned protocols and develop therapeutic knowledge sufficient to support role and responsibilities.

Requirements

• BA/BS degree with at least 5 years of experience in pharmaceutical related drug development or direct equivalent experience.
• Experience in managing clinical trial sites and ensuring compliance with regulatory requirements.
• Strong communication and interpersonal skills to develop relationships with site staff and stakeholders.
• Ability to work collaboratively in a team environment and manage multiple priorities effectively.
• Proficiency in clinical trial management systems and documentation practices.

Nice-to-haves

• Experience with early and late phase clinical trials.
• Knowledge of risk-based monitoring approaches and site management strategies.
• Familiarity with ICH-GCP guidelines and local regulations.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid holidays
• Flexible scheduling options
• Professional development opportunities