Astellas Canada – Data Management Lead
At Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients.
What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture, and the passion of our talented people.
Making a positive impact on patients’ lives is the purpose behind everything we do. At Astellas, we are relentless in our pursuit of scientific progress and in tackling unmet medical needs, demonstrated by our legacy in oncology, overactive bladder and transplant and our impressive pipeline in women's health, blindness and regeneration, genetic regulation, immuno-oncology, mitochondria and targeted protein degradation.
About Us:
We are a global pharmaceutical company headquartered in Japan, with a team of more than 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.
In Canada, we are growing to meet the exciting opportunities realized by our legacy brands and rich pipeline of innovative treatments.
We are looking for candidates who will thrive in our entrepreneurial and empowering environment where talent and leadership flourish. Do your values align with our Astellas Way - patient focus, ownership, results, openness and integrity? Then we would love to hear from you.
From the first day in role, everyone at Astellas has a responsibility for creating a brighter future for patients around the world. We nurture exceptional relationships with our employees to allow them to thrive, foster innovation, and deliver exceptional business results. We work to create a culture where our people feel empowered to pursue brave ideas and ambitious outcomes, to have the confidence to be accountable for a higher standard of performance and embody a competitive and solutions-oriented mindset.
Our expertise, science and technology make us a pharma company. Our open and diverse culture is what makes us uniquely Astellas.
Astellas Pharma Canada (APCA) is currently searching for a Data Management Lead.
Purpose and Scope
The position represents Data Science as the data management contact in clinical study team meetings and some extended team discussions. This role is responsible for study level data management activities of moderate to high complexity within a drug development program for Data Science (DS). This includes all aspects of 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 to ensure that studies are executed within the agreed timelines and according to the agreed global standards and processes. The position has full accountability for the DM deliverables across multiple studies and is responsible for all vendor oversight for outsourced DM activities.
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.
Responsibilities and Accountabilities
Demonstrated knowledge and experience of all aspects of the Data Management (DM) discipline. Ability to support multiple studies concurrently with minimal oversight by functional manager. Advocates the DM position within study team meetings and oversees vendor staff supporting DM work. May act as a functional DM expert for a specific DM specialty area, such as data standards, Medical Coding, eSource, data visualization and analytics, etc. Oversees multiple DM vendors and provides training as necessary. Review Key Risk Indicator (KRI) 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. Proactively shares and provides suggestions on how to improve vendor oversight with functional manager. Uses metrics and key performance indicators (KPIs) to monitor vendor performance. Documents any process related deviations and communicates to functional manager. Well-versed in regulatory guidelines and issues (i.e., GCP), and understands the connection to DM deliverables. Leads the data review meetings with Medical, Clinical Operations, Statistics, and Stats Programming in support of key reporting events or database lock plans.
External Data Manager:
Functions as the study lead 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. Works with data standards subject matter experts to ensure data transfer structures and test codes comply with SDTM and/or Astellas standard data models. Assists and provides study level support to study teams and other team members