Clinical Site Manager Lead I

Clinical Site Manager Lead I

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at  www.astellas.com .

Purpose and Scope :

This position is accountable for the direct management of assigned late phase monitoring / site management related clinical trial staff across all clinical trial types, which may include post-POC interventional drug 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, 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.

Essential Job Responsibilities :

• 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

Quantitative Dimensions :

Responsible for overseeing, developing and aligning resources to ensure effective monitoring of clinical trials and a robust talent pool.