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Lead Data Management Specialist
3 months ago
Astellas Canada – Lead Data Management Specialist
At Astellas, we are committed to being a pioneering, value-driven innovator in the life sciences sector. Our mission is to be at the forefront of healthcare transformation, translating innovative science into tangible VALUE for patients.
What distinguishes us is our unwavering focus on patients, our groundbreaking innovations, our collaborative culture, and the dedication of our talented workforce.
Our goal is to positively impact patients' lives, which drives every action we take. Astellas is relentless in our pursuit of scientific advancement and addressing unmet medical needs, as evidenced by our legacy in oncology, overactive bladder, and transplantation, along with a robust pipeline in women's health, vision restoration, genetic regulation, immuno-oncology, mitochondrial health, and targeted protein degradation.
About Us:
We are a global pharmaceutical organization headquartered in Japan, employing over 14,000 individuals across approximately 70 countries worldwide. We rank among the Top 30 global biopharma companies based on revenue and are anticipated to be one of the Top 10 Cancer Drug Manufacturers of 2024, as recognized by Fierce Pharma.
In Canada, we are expanding to seize the exciting opportunities presented by our established brands and innovative treatment pipeline.
We seek candidates who will excel in our entrepreneurial and empowering environment, where talent and leadership can thrive. Do your values resonate with our Astellas Way - patient focus, ownership, results, openness, and integrity? We would be eager to hear from you.
From day one, every member of Astellas is responsible for contributing to a brighter future for patients globally. We cultivate exceptional relationships with our employees, enabling them to flourish, foster innovation, and achieve outstanding business results. Our culture encourages individuals to pursue bold ideas and ambitious outcomes, empowering them to be accountable for high performance and embody a competitive, solutions-oriented mindset.
Our expertise in science and technology defines us as a pharmaceutical company, while our open and diverse culture makes us uniquely Astellas.
Astellas Pharma Canada (APCA) is currently seeking a Lead Data Management Specialist.
Purpose and Scope
This role serves as the primary data management contact within clinical study team meetings and broader team discussions. The position is accountable for managing study-level data management activities of moderate to high complexity within a drug development program for Data Science (DS). This encompasses all aspects of data management deliverables (data standards, eSource, medical coding, database construction, external data, central monitoring, etc.), along with comprehensive oversight of all data management activities for assigned projects to ensure studies are conducted within established timelines and adhere to global standards and processes. The position carries full accountability for data management deliverables across multiple studies and oversees all vendor activities related to outsourced data management.
The role may specialize in collecting 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 applies their expertise in external data to standardize and streamline the review and cleaning of data received from sources other than the EDC system. The position manages the collection of external data, performs reconciliation, and conducts data cleaning activities. This role collaborates with external providers and other stakeholders to resolve data discrepancies throughout the clinical study process.
Responsibilities and Accountabilities
- Demonstrated knowledge and experience in all facets of the Data Management (DM) discipline, with the ability to support multiple studies concurrently with minimal oversight.
- Advocates for the DM position during study team meetings and supervises vendor staff supporting DM activities.
- May serve as a functional DM expert in a specific specialty area, such as data standards, medical coding, eSource, data visualization, and analytics.
- Oversees multiple DM vendors and provides necessary training.
- Reviews Key Risk Indicator (KRI) outputs across sites, regions, and countries. As needed, assesses study-level operational and patient data to support investigations and root cause analyses of observations.
- Assists the team in evaluating centralized monitoring observations to identify potential issues and risks during study execution.
- Conducts vendor oversight activities across multiple studies, proactively sharing suggestions for improving vendor oversight with the functional manager. Utilizes metrics and key performance indicators (KPIs) to monitor vendor performance.
- Documents any process-related deviations and communicates them to the functional manager.
- Possesses a strong understanding of regulatory guidelines and issues (i.e., GCP) and recognizes their connection to DM deliverables.
- Leads data review meetings with Medical, Clinical Operations, Statistics, and Stats Programming in support of key reporting events or database lock plans.
External Data Manager:
- Acts as the study lead for various external data types, testing methodologies, and external data provider setups.
- Creates and maintains study-level data transfer specifications (i.e., external data specifications).
- Processes test transfers and collaborates with external data providers to verify data structure and format.
- Defines study-level specifications for reconciliation checks and exception listings to facilitate reconciliation between EDC data and external data.
- Manages external data transfers, reviews discrepancy outputs from reconciliation checks and exception listings, and collaborates with Data Management, Study Management, Bioanalysis, and/or Stats/Stats Programming and/or 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.
- Provides study-level support to study teams and other team members.
