Clinical Site Management Lead CRA Regional Manager

About Astellas

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