Astellas Pharma Associate Data Management Director, Decentralized Clinical Trials (DCT) in Northbrook, Illinois
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 Northbrook, Illinois. 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 & Scope:
This technical lead position is accountable for the oversight, strategic input and execution of Data Science deliverables for Astellas' Decentralized Clinical Trials (DCT) initiative. Data Science deliverables include DCT Process and Standards for workflow, dataflow, data collection, data transfer, data integrations and data storage; DCT Operational Excellence, Regulatory Compliance and Vendor Oversight; DCT Systems, Intersystem Integrations and Platform Oversight; and DCT Cross-Functional Coordination and Collaboration.
The Associate Data Management (DM) Director acts as a fully independent technology lead, supporting the Astellas DCT technology project. This role may also take a leading role for DM in case of in-licensing or co-development projects. The Associate DM Director requires limited supervision and day-to-day support from line managers and collaborates with core team members globally, as well as Medical Affairs to defend the interests of Data Management/ DCT. The Associate Director represents Data Science as the leading subject matter expert and advocate for DM standards, processes, emerging data technologies focused on DCT, industry level best practices, and documentation strategies.
The Associate DM Director has both strong therapeutic area background and experience, combined with the sufficient breadth of experience through support of multiple TAs and customer stakeholders. The Associate Data Management Director provides expert level DCT data science knowledge and consultation to the global Data Management team, as well as to DS Leadership and other Development functions and stakeholders. The Associate DM Director will also represent Astellas in external industry Decentralized Clinical Trial (DCT) collaborations and process improvement discussions, with a focus on networking discussions on best practices and advancing the discipline and technology evolution for clinical data management within Astellas and across industry.
Essential Job Responsibilities:
Provides mastery level clinical data science process and technical expertise to key development project teams. May have responsibility for data management system vendors and solutions (e.g., DCT platforms, electronic Clinical Outcome Assessments (eCOA), and external data). Supports multiple drug development programs end-to-end through all phases of the program. Has a broad understanding of how the data come together, and/or how system vendors and solutions function, to support the submission strategy for the compound. Experienced in supporting multiple Therapeutic Areas (TAs) across different clinical trial phases, I-IV.
Has a comprehensive understanding of data standards (i.e., CDISC, HL7), and represents data standards interests with key stakeholders and study teams.
Provides leadership, liaises with key stakeholders and advocates the data management position, with the ability to make decisions across development projects, TAs, and/or system vendors and solutions when necessary. Shares data management and/or data management/DCT systems, process, knowledge and expertise with colleagues in study teams, across functional lines and may influence Data Science (DS) management as applicable.
Responsible for ensuring that all supporting documentation for studies/systems is maintained in accordance with processes to ensure quality, traceability and compliance.
Develops risk-based quality and performance strategies for Data Management (DM) work processes in support of larger Development risk-based data strategies.
Leads strategic technology and/or process improvement projects and contributes to improvement efforts. Implements agreed improvement actions and monitors effects after implementation. Oversees the development of appropriate methodology or delivery strategy to improve the delivery of solutions for data management systems and technologies when applicable.
Oversees adherence to timelines and processes for work assigned to data management or data management systems vendors across drug development projects.
Ensures adoption and compliance to data standards and DM SOPs across all studies within a specific drug development project or as applicable to a variety of data management systems. Provides oversight to ensure delivery of quality work products. Ensures multiple studies within a drug development project are aligned in work processes and data standards. Monitors work against established internal and industry performance benchmarks.
Advises Data Management and Data Science leadership on system or procedural solutions and recommends future initiatives relevant to data management, data standards and/or system vendors and solutions (e.g., DCT). May be responsible for development and implementation of processes and standard operating procedures (SOPs).
Develops relationships with vendors to maximize the benefit for Astellas and increase operational efficiencies. Ensures that DM vendor working practices are in alignment with Astellas expectations (e.g., SOP reviews, new vendor selections, QA audit representative).
May lead the governance discussions with key DM / DCT technology vendors as the Astellas Lead.
May perform due diligence activities for in-licensing or co-development projects -- acts as the DM lead in these efforts.
Maintains a strong network of contacts both within and outside of Astellas to further develop breadth and depth of knowledge. Stays abreast of industry developments. Plays a leadership role in industry or professional organizations. Develops and maintains relationships with peers in the industry.
The Associate Data Management Director is assigned to multiple drug-development programs and acts as the DM Lead for all studies within those programs at the study level.
Depending on business need, the incumbent may have overall responsibility for leadership and process expertise for specific Data Science roles/technologies (e.g., DCT). The incumbent will also be accountable for developing the longer-term strategies for key data management roles/technologies.
This role may also support the data management teams globally by providing leadership, consultation and expert level DM advice whenever needed across DS for associated data technologies (e.g., DCT, data standards, eCOA, Labs, Coding, etc.).
The Associate Data Management Director is expected to provide expert consultation, advice and process & technology leadership to the multiple vendors supporting DM and to highlight any areas of risk to the DM Leadership team.
The Associate Data Management Director monitors KPIs and other key study metrics, to ensure alignment to DS and Development goals for key drug development projects.
Reports to Director, Data Management or Director, Data Management Solutions, depending on role.
Participates in drug program level discussions, and contributes DCT subject matter expertise to study teams, as needed.
Independent worker, working under loose supervision of Line Manager.
No direct reports but may oversee the activities of lower level Data Management staff assigned to the individual studies within a drug program and/or supporting data standards, data management system vendors and solutions.
Closely collaborates with cross-functional study team members (e.g., GDOL, Study Manager, Clinical Programmer, etc.) or other cross-functional staff such as procurement, systems and IT staff as appropriate.
Interacts with counterparts globally and is expected to provide focused support to all global DS team members, as driven by business need.
Interacts with GDOL, GSTATL, GMRL and other core and extended drug development project team members.
BS/BA degree in a biological science, health-related or computer science field. Combination of data management experience and college courses in a related field may be considered.
10+ years related experience in pharmaceutical, clinical research or health services industry with a minimum of 8 years' experience as Data Manager, with progressive levels of responsibility.
Demonstrated mastery of DM skills in multiple development programs, inclusive of all activities from program inception to regulatory submission.
Regulatory submission experience
Proven excellent leadership and subject matter expertise for key DM related to complex global process improvement initiatives.
Active contribution to inspections and major (vendor) audits.
Strong cross-functional understanding of processes of data management, clinical programming, biostatistics and clinical, with mastery level expertise expected in the DM discipline.
Strong computer skills, including database management software, reporting tools, medical coding tools, etc.
Solid understanding of CDISC data standards.
Seasoned expert with DCT, EDC and/or eCOA systems/devices, including implementation of such systems.
Excellent verbal and written communication skills.
Proven ability to work with and influence individuals across multiple disciplines in international environment.
Proven superior project management and organizational skills in order to prioritize work for self and others to ensure timelines are met, oversee activities of multiple studies.
Thorough knowledge of medical terminology.
In-depth knowledge of the drug development and data management processes.
Very good knowledge of international regulations for clinical trials (e.g. GCP).
Ability to communicate effectively and maintain effective relationships. Must be able to influence staff in other Astellas groups.
SCDM Certified Clinical Data Manager (CCDM) preferred.
Demonstrated success in execution of strategies for DCT
Experience in operationalizing Decentralized Clinical Trials, supported by a technology platform solution
Medical, Dental and Vision insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays, including year-end shutdown
401(k) 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
Category Data Science
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans