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 Ontario, Canada. 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 position acts as a data management lead and represents Quantitative Sciences and Evidence Generation (QSEG) as the data management (DM) key contact in clinical study team meetings and some extended team discussions. This role is responsible for study level data management activities within a drug development program. This includes all aspects of study level DM deliverables (data standards, eSource, Medical Coding, database build, external data, central monitoring, etc.), and overall management/oversight of all data management activities for assigned projects. The individual ensures that studies within the program are executed within the agreed timelines and according to the agreed global standards and processes. The individual has full accountability for the DM deliverables across multiple studies and is responsible for all vendor oversight for any outsourced DM activities.
The position contributes expert level Data Management knowledge and consultation to the clinical program team, as well as to other stakeholders within Development. This role may act as a key contact and lead of DM process and technical/systems improvement initiatives.
The position may specialize in the collection of clinical data from external data providers (e.g., central laboratories, ECG laboratories, and Biopharmaceutical laboratories), and act as the study level External Data Manager. In this capacity, the individual is responsible for applying their external data expertise to standardize and streamline review and cleaning of data received through routes other than the EDC system. The position manages the collection of external data, performs reconciliation, and performs data cleaning activities. This role also works with external providers and other stakeholders to resolve data discrepancies throughout the course of clinical study conduct.
Essential Job Responsibilities:
Very strong subject matter expertise in the Data Management (DM) discipline. Can support multiple studies concurrently with little to no oversight by functional manager. Advocates the DM position on technical processes within study team meetings and with Statistics Lead. Shares DM process knowledge with study team colleagues and cross functional peers. Oversees multiple DM vendors and provides training and subject matter expertise to lower-level DM peers. Leads by example by providing data management expertise and input into drug development programs. May act as a functional DM expert for a specific DM specialty area, such as data standards, Medical Coding, eSource, external data, data visualization and analytics, etc. Review Key Risk Indicators (KRIs) 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. Support the team in assessment of centralized monitoring observations to identify potential issues and risks occurring during study conduct. Performs vendor oversight activities across multiple studies. Reviews and gives input in vendor oversight processes. Proactively shares and provides suggestions on how to improve vendor oversight. Uses metrics and key performance indicators (KPIs) to monitor vendor performance. Documents any process related deviations and communicates to functional manager. Triggers discussion or takes immediate action if there are concerns with respect to quality of DM deliverables. Expert cross-functional understanding on the impact of data management processes to other stakeholders. Leads the data review meetings for all data sources with Medical, Clinical Operations, Biostatistics, and Programming to highlight and discuss deviations to the protocol and specific data values relevant for the analysis/determining subject populations.External Data Manager:
Functions as the subject matter expert for multiple external data types, testing methodologies, and external data provider setup. Creates and maintains study level data transfer specifications (i.e., external data specifications). Processes test transfers and liaises with the external data provider to verify the data structure and format. Defines the study level specifications for reconciliation checks and exception listings to perform the reconciliation between EDC data and external data. Manages external data transfers, reviews the discrepancy output of reconciliation checks and exception listings, and works with Data Management, Study Management, Bioanalysis and/or Stats/Stats Programming and/or the external data providers to resolve discrepancies. Oversees or acts as the intermediary between Data Management, Statistical Programming, and external data provider regarding external data specifications, data transfers, and technical issues. Works with data standards subject matter experts to ensure data transfer structures and test codes comply with SDTM and/or Astellas standard data models. Leads the development and maintenance of external data standards and the processes needed to support their use and evolution. Assists and provides study level support to study teams and other team members.