Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
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Astellas is announcing a Central Monitoring Manager position located in Northbrook, IL
Purpose & Scope:
The Senior Central Monitoring (CM) Manager acts as a study level centralized monitoring contributor, supporting 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 as a central monitoring subject matter expert and advocate for CM 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 Manager is responsible for developing and implementing the requirements of a centralized monitoring plan and performing all of the data driven components of centralized monitoring (including aggregate KRI review, statistical monitoring output review and site risk review) as key components of RBM. The aggregate KRI review by the Central Monitor supports CRO oversight and early trend and signal detection that will lead to better study integrity and data quality.
The Central Monitor provides strong subject expertise to key development project teams. Application of all end-to-end activities involved in centralized monitoring to support multiples drug development programs (3-5). Has a big picture understanding of how the data come together to support the submission strategy for the compound and has the ability to detect signals and/or trends in summarized data. Experienced in supporting multiple Therapeutic Areas.
The Central Monitor is responsible for collaborating with the cross-functional study team to establish the centralized monitoring strategy and requirements, conducting centralized monitoring during the study(s) and reconciling all centralized monitoring observations and documentation at the close of the study(s).
The following activities are the responsibilities of the Central Monitor:
- Develop the centralized monitoring plan, incorporating feedback and discussion with the study team to capture the study requirements for centralized and statistical monitoring.
- Contribute to key activities of study start up: study risk assessment & identification and definition of critical data.
- Lead the study team through the process of Key Risk Indicator (KRI) identification for study level centralized monitoring and definition of appropriate thresholds to effectively monitor study progress around the associated KRIs.
- Key contact and lead for the setup of the statistical monitoring tool. Work with study team to make key decisions around data and settings that will support statistical monitoring.
- Participate with study team in CRO evaluation and startup activities as required. As appropriate, Central Monitor should provide feedback on previous experiences with the potential vendors as it relates to centralized monitoring activities.
- Provides the requirements for the set-up of any study-specific systems or tools supporting central monitoring data review.
- Review KRIs and statistical monitoring outputs in aggregate across sites, regions and countries. As needed, review study level operational and patient data to support the investigation and root cause analysis of observations.
- Review and interpret multiple data sources to identify potential issues with study sites or data quality with the study team.
- Conduct centralized monitoring per the study specific plan and quality procedures.
- Support the team in assessment of centralized monitoring observations to identify potential issues and risks occurring during study conduct.
- Track and investigate observations to determine best mitigation action and follow up.
- Communicate centralized monitoring observations to study team and appropriate cross-functional partners.
- Lead centralized monitoring observations review discussion.
- For any fully outsourced work, ensure/oversee the execution of central monitoring including the documentation of centralized monitoring activities and inspection readiness.
- Apply lessons learned to centralized monitoring, including update of the centralized monitoring plan and functional monitoring activities as required throughout the study conduct.
- Participate in issue evaluation and risk review meetings.
- Collaborate with study manager to investigate any identified issues with CRO monitoring partners, based on centralized monitoring findings.
- Complete corrective and preventive actions related to identified issues as required.
RBM Process Improvement:
- Throughout the study, and at study close, ensure all observations, investigations, actions and communication are documented and adequately stored in study team files.
- Participate in lessons learned discussions with cross-functional study team.
- Contribute to activities that define, deliver, and optimize the centralized monitoring 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 best practice to internal and external stakeholders as required
- Actively provide feedback on RBM and centralized monitoring process and areas for improvement.
- Contribute to the development of centralized monitoring processes, work tools and training content.
- May participate in vendor evaluation and provide feedback on performance as required.
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 Manager supports approximately 3-5 compounds and is the study level CM Lead for all studies within those compounds.
- The Senior Central Monitoring Manager provides oversight, consultation, advice and central monitoring 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.
- Reports to 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.
- BS/BA degree in a biological science, statistics, health-related or computer science field. Advanced degree preferred.
- Generally, 7 plus years related experience in pharmaceutical, clinical research or health services industry with a minimum of 5 years' experience as clinical study manager, data manager or biostatistician, with progressive levels of responsibility.
- Demonstrated data analytical and/or site monitoring skills in multiple development programs, inclusive of all activities from program inception to regulatory submission.
- Experience in multiple Therapeutic Areas or disease state/indications desired.
- Regulatory submission experience.
- Proven excellent leadership and subject matter expertise for key process improvement initiatives.
- Active contribution to inspections and major (vendor) audits.
- Proven skills in outsourced vendor oversight.
- Strong cross-functional understanding of processes of clinical study management, data management, clinical programming, and biostatistics with senior level expertise expected in at least one of those disciplines.
- Strong computer skills, including database management software, data analysis &reporting tools, project management tools, etc.
- Excellent verbal & written communication and critical thinking skills.
- Proven ability to work with and influence individuals across multiple functions and disciplines
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