Data Management Lead

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.

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.

Requirements

Qualifications
Required:

• BS/BA degree in a biological science, health-related or computer science field.
• Generally, 8 plus years related experience in pharmaceutical, clinical research or health services industry with a minimum of 6 years' experience as Data Manager/External Data Manager, with progressive levels of responsibility.
• Demonstrated expertise in DM, inclusive of all activities from program inception to regulatory submission.
• Proven leadership and subject matter expertise for key DM related global process improvement initiatives.
• Prior inspection and major (vendor) audit experience.
• Solid understanding of clinical data standards (i.e., CDISC), and their application in use within clinical studies.
• Expert in understanding of cross-functional processes across data management, statistics, and clinical operations, with mastery level expertise expected in the DM discipline or External Data specialty.
• Strong computer skills, including database management software, reporting tools, medical coding tools, etc.
• Solid understanding of central monitoring tools and risk-based quality management (RBQM) principles.
• Proven project management and organizational skills, in order to prioritize work for self and others to ensure timelines are met.
• Strong understanding of different types of data sources in a clinical trial setting and/or expertise with external data types.
• Proven ability to think critically to enable judgement-based decisions related to data management activities.
• Ability to influence study teams and drive decision making.
• Demonstrated learning agility, ability to adopt new technologies for Data Management.

Preferred:

• SCDM Certified Clinical Data Manager (CCDM) preferred.
• Experience with eClinical Solutions elluminate is a plus.

Working Environment:

• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• RRSP match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Referral bonus program

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