Clinical Site Management Lead (CRA Regional Manager)

Astellas; Northbrook (IL); Hybrid; USD 144,000 - 206,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

Paid Time Off

401(k) match

Annual Corporate Bonus

Long Term Incentive Plan

Company fleet vehicle

Job summary

Astellas is seeking a Site Monitoring & Management leader based in Northbrook, IL, with global responsibilities across Early and Late-Stage trials. You will oversee up to 12 direct reports, drive resource planning, onboarding, training, and development, and ensure high-quality monitoring across trials with operational excellence.

Role requires collaboration across EU, US and Japan, strong knowledge of risk-based monitoring and ICH/GCP, and fluency in English.

Qualifications

• BA/BS degree with 8+ years in global drug development; advanced degree preferred.
• Minimum of 4 years site monitoring and people management experience.
• Strong leadership and cross-functional collaboration skills.
• Extensive expertise in risk-based monitoring and ICH/GCP guidelines.
• Experience across multiple development phases and therapeutic areas.
• Proven ability to lead global processes or system improvements.
• Fluent in English; local language may be required depending on region.

Responsibilities

• Resource planning, recruitment, mentoring, development and retention of site monitoring staff.
• Manages and allocates monitoring resources to trials and monitor performance on assigned trials.
• Provides direction and learning opportunities to enhance direct reports' development.
• Oversees adherence to timelines and quality standards for staff work.
• Serves as escalation point for monitoring/site management topics.
• Guides regional leads in KOL interactions, communications and health authority submissions.
• Collaborates with portfolio operations and PECs leadership to align standards.
• Identifies and implements process improvements for clinical monitoring.

Skills

Leadership

Cross-functional collaboration

Risk-based monitoring

ICH/GCP knowledge

Global program exposure

Communication skills

Education

BA/BS degree

Advanced degree preferred

Job description

Job Description

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose and Scope:

• This position is accountable for the direct management of assigned monitoring/site management related clinical trial staff across all clinical trial types, which may include pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
• Accountable for the identification, onboarding, training and development of monitoring clinical trial talent to support the planning, initiation, execution and close-out of clinical trials with operational excellence. Individuals in this role will also provide leadership/mentorship, in a matrix setting, for activities that support clinical trial teams.
• This position is accountable to the Head, Early or Late-Stage Site Monitoring & Management, and will provide input into departmental budget and resourcing strategies, including development and implementation of global processes and procedures, non-drug product initiatives, and coaching of monitoring staff during execution of development trials.
• This position provides functional leadership and management globally of < 12 direct reports

Responsibilities and Accountabilities:

• Responsible for resource planning, recruitment, mentoring, development and retention of site monitoring & management staff
• Manages and allocates monitoring resources to trials and monitor performance on assigned trials for monitoring staff (up to 12 direct reports)
• Provides direction, leadership and learning opportunities to enhance individual development of direct reports in support of providing best-in-class site monitoring across the portfolio
• Provides oversight and guidance in completing monitoring and site management related activities according to agreed timelines and quality standards, including identifying areas for additional training and development
• Oversees adherence to timelines, standards, processes for work assigned to their staff
• Serves as a point of escalation for clinical monitoring/site management related topics or issues from their staff
• Oversees and provide guidance to Clinical Operations Leads and/or Clinical Trial Leads in regional Key Opinion Leader (KOL) interactions, communications; and submissions to Health Authorities within their region/country of responsibility, aligned to the overall asset strategy.
• Responsible for compliance of direct reports with training and identification and support for any training needs
• Facilitates and supports global trial monitoring operational standards and tools
• Anticipates, recognizes and facilitates problem solving to support site monitoring & management staff and rapidly addresses and mitigates potential performance issues
• Collaborates effectively with portfolio operations Leads, clinical operations leads, Center of Excellence and PECs leadership to ensure site monitoring & management staff are delivering as expected and to ensure common framework and standards across clinical programs and trials
• Ability to collaborate with peers in Clinical Operations across Early and Late-Stage Clinical Operations, cross-functionally and regionally, including relevant counterparts globally, to align on best practices for clinical monitoring staff
• Identifies, escalates, and facilitates process improvements relevant to clinical trial monitoring and site management
• Contributes to development and implementation of best-in-class monitoring/site management standards and processes
• Responsible for overseeing, developing and aligning resources to ensure effective monitoring of clinical trials and a robust talent pool

Required Qualifications:

• BA/BS degree with at least 8 years of executing global drug development programs and trials; Advanced degree preferred
• Minimum of 4 years site monitoring and direct people management experience
• Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives
• Must have extensive expertise in risk-based monitoring strategies and strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations
• Must have experience working across multiple phases of development and in multiple therapeutic areas
• Demonstrated ability to successfully identify and lead global processes or system improvement initiatives
• Must have a strong knowledge of clinical development processes and conducting global clinical programs
• Must have proven leadership skills and effective written and verbal communication skills
• Fluent in English. Depending on hiring region, may also be required to be fluent in local language.

Location and Working Environment

This position is based in Northbrook, IL. Remote work from anywhere in the US is available.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

This position is a global role with strong interaction with various disciplines and international stakeholders

• Highly matrixed environment requiring cross-regional coordination.
• Frequent interaction with senior leadership and governance bodies.
• Collaboration across EU, US, and Japan time zones.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. Real‑world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organizational Values and Behaviors

Values: Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors: We come together as 'One Astellas', working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.

Salary Range

$144,060 - $205,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

*The salary range provided applies to US only and does not apply to any other locations outside of the US

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company fleet vehicle for eligible positions

Our organization is committed to diversity, equal opportunity, and affirmative action. We are an equal opportunity employer. All applicants will be considered without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or any other protected characteristic.