Senior Centralized Monitoring Programming Manager

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.

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

The Senior Central Monitoring (CM) Programming Manager will support study level centralized monitoring, for Astellas drug development projects of simple to moderate complexity. The incumbent requires limited supervision and day-to-day support from line management. The Senior Manager represents Data Science and will be responsible for building tools that support the central monitoring processes.

The Central Monitor will support the implementation and ongoing adaptation of procedures to ensure Astellas maintains a robust, comprehensive centralized monitoring program. This includes providing subject matter expertise to the development of processes and tools, and to oversee our external partnerships with vendors performing study level work.

Essential Job Responsibilities:

The Senior Central Monitoring Programming Manager is responsible for reviewing and configuring the technical components of the centralized monitoring tools (CluePoints) and supporting the data driven components of centralized monitoring (including aggregate Key Risk Indicator (KRI) review, statistical monitoring output review and site risk review) as key components of Risk Based Management (RBM).

The Senior Central Monitoring Programming Manager provides strong programming and subject expertise to key development project teams. Application of all end-to-end programming activities involved in centralized monitoring to support multiples drug development programs. Has a big picture understanding of how the data come together to support the submission strategy for the compound and has the ability to interpret various data sources and data types.

The following activities are the responsibilities of the Senior Central Monitor Programming Manager:

Study Start:

• Key contact and lead for the setup of the central monitoring tool (CluePoints). Work with study team to make key decisions around data and settings that will support statistical and central monitoring.
• Support the centralized monitoring plan development, incorporating feedback and discussion with the study team to capture the study requirements for centralized and statistical monitoring.
• Support the development of requirements for the set-up of any study-specific systems or tools supporting central monitoring data review.
• Engage and oversee central monitoring programming vendor.

Study Conduct:

• Review and interpret multiple data sources to identify potential issues with study sites or data quality with the study team.
• For any fully outsourced programming work, ensure/oversee the execution of central monitoring programming including the documentation of centralized monitoring programming activities and inspection readiness.
• Apply lessons learned to centralized monitoring programming, including update of the centralized monitoring programming specification or libraries throughout the study conduct.

RBM Process Improvement:

• Contribute to activities that define, deliver, and optimize the centralized monitoring programming capabilities and processes
• Participate in discussions regarding identification of new KRIs for inclusion in Astellas standard KRI library
• Works with appropriate groups to obtain approval for new KRIs and addition to the KRI library
• Provide recommendations on centralized monitoring programming best practice to internal and external stakeholders as required
• Actively provide feedback on RBM and centralized monitoring programming process and areas for improvement.
• Contribute to the development of centralized monitoring programming processes, work tools and training content.
• May participate in vendor evaluation and provide feedback on performance as required.

Quantitative Dimensions:

The Data Science department provides statistical, biometrical, medical writing, centralized monitoring and data management/warehousing expertise for all R & D projects and marketed products, encompassing Phase I -- IV studies.

Qualified centralized monitoring expertise for clinical studies is a regulatory requirement and is carried out in accordance with international regulations (ICH, FDA, EMA) and internal Astellas SOPs and working practices.

• The Senior Central Monitoring Programming Manager provides oversight, consultation, advice and central monitoring programming process leadership to the multiple vendors supporting any study related outsourcing efforts.
• Monitors KPIs and other key study metrics for assigned studies. Escalates any issues with study team, as necessary.

Organizational Context:

• Reports to Associate Director, Central Monitoring.
• Peers -- has between 2 - 4 peers at same level
• Participates as an ad-hoc member to study level project teams
• Independent worker, working under supervision of Line Manager.
• No direct reports but may oversee the activities of contract resources assigned to the individual studies within a drug program.
• Closely collaborates with cross-functional study team members (e.g., GDOL, Study Manager, Data Manager, Statistician, Stats Programmer, Medical Monitor, etc.)
• Interacts with GDOL, GSTATL, GMWrL and other core and extended drug development project team members as necessary.