Job Description

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.
Astellas' Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company's strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.

Purpose and Scope:

The primary purpose of the position is to act as a study level centralized monitoring contributor, supporting Astellas drug development projects of moderate to high complexity. The incumbent requires limited supervision and day-to-day support from line management. The individual represents Quantitative Sciences and Evidence Generation (QSEG) as a Risk Based Quality Management (RBQM) and central monitoring subject matter expert and advocate for CM processes. The Central Monitor will support the implementation and ongoing evolution of procedures to ensure Astellas maintains a robust, comprehensive RBQM (RBQM) central 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.

Responsibilities and Accountabilities:

The Central Monitor is responsible for collaborating with the cross-functional study team to establish the risk assessment strategy, central monitoring strategy, including but not limited to centralized statistical monitoring, site quality assessments, Quality Tolerance Limit (QTLs) specifications, conducting central monitoring during the study(s), and reconciling all central monitoring observations & documentation at the close of the study(s). The following activities are the responsibilities of the Central Monitor:
Facilitates the risk assessment for study teams

Develops the central monitoring plan, incorporating feedback and discussion with the study team to capture the study requirements for the study-specific central monitoring strategy.

Contributes to key activities of study start up, conduct, and close-out, including: identification of critical data, Key Risk Indicator (KRI) identification for study level centralized monitoring, and definition of appropriate thresholds to effectively monitor study progress around the associated KRIs and QTLs.

Acts as the study-level primary contact, and subject matter expert for the centralized statistical monitoring tool.

Reviews study-level KRIs, QTLs, statistical monitoring data outputs in aggregate across sites, regions, and countries.

Supports the team in assessment and mitigation of centralized monitoring observations to identify potential issues and risks occurring during study conduct. Leads central monitoring observations review discussions with the clinical study team.

Ensures/oversees the execution of central monitoring deliverables for any outsourced components.

Collaborate with study manager to investigate any identified issues with CRO monitoring partners, based on centralized monitoring findings.

Throughout the study, and at study close, ensure all observations, investigations, and actions are documented and adequately stored in Trial Master File.

Contributes to activities that define, deliver, and optimize the centralized monitoring capabilities and processes.

May participate in vendor (CROs or technology providers) evaluation and provide feedback on performance as required.

Required Qualifications:

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 central monitor, 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.

Proficiency in computer systems including MS Word, MS Excel, MS PowerPoint and MS Outlook.

Preferred Qualifications:

Professional certification in a Clinical Development discipline

Category
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans