Data Management Director jobs in Schaumburg, IL

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 and Scope:

The Associate Data Management (DM) Systems Director acts as a fully independent technology lead, supporting the most complicated Astellas drug development programs or technology projects. This role may also take a leading role for DM in identifying new DM systems and vendors. The Associate DM Systems 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 and the use of DM systems. The Associate DM Systems Director develops, manages and supports data management (and related) systems (e.g., EDC, reporting and visualization tools, coding tools) used to collect, review and clean data in Astellas’ phase I-IV clinical trials.

The Associate DM Systems Director represents Data Science as the leading subject matter expert and advocate for the processes, emerging data technologies and innovations, industry level best practices, and documentation strategies. This individual may also oversee the standards, handling, and management of all external sources of data being managed by the Astellas DM organization. This includes, but is not limited to: central labs, imaging data, biomarkers, and PK/PD data.

The Associate DM Systems Director has strong IT/systems background and experience, combined with breadth of experience through support of multiple drug development teams and customer stakeholders. The Associate DM Systems Director provides expert level DM systems knowledge and consultation to the global Data Management team, as well as to Data Science (DS) leadership and other Development functions and stakeholders. The Associate DM Systems Director will also represent Astellas in external industry 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 management systems process and technical expertise to key development project teams. May have responsibility for data management system vendors and solutions (e.g., Electronic Data Capture (EDC) and external data. Has a broad understanding of how the data come together, and/or how system vendors and solutions function.

• Has a broad understanding of data standards (i.e., CDISC), and can translate data standards requirements into key DM systems functionalities or systems needs.

• Oversees database build activities (e.g., eCRFs, change requests, edit checks, special actions/functions, derivations, interface configuration) as needed and troubleshoots study build issues and/or system integration issues.

• Creates and maintains standard specifications and standard programs/macros for external data vendors (e.g., central lab, PK, ECG). Defines specifications to automate reconciliation (i.e., create functional requirements for standard macros) and to create SAS programs to perform external data checks against the data transfers received for data reconciliation.

• Provides clean external data as SAS datasets as required by Statistical Programming for statistical analysis.

• Seeks to make continual improvement to processes and templates used to create technical specifications.

• Leads the development of complex reports using JReview, Business Objects, Crystal Reports, etc. Troubleshoots and resolves and data report issues.

• Provides leadership, liaises with key stakeholders and advocates the data management systems 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 systems, process, knowledge and expertise with colleagues in study teams, across functional lines and may influence Data Science management as applicable.

• Responsible for ensuring that all supporting documentation for DM systems is maintained in accordance with processes to ensure quality, traceability and compliance.

• 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 systems vendors across drug development projects.

• 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. 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 technology vendors as the Astellas Lead.

• 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.

Quantitative Dimensions:

• The Associate DM Systems Director is assigned to multiple systems (up to 5) and acts as the DM Lead for key DM Systems (e.g. Rave).

• Depending on business need, the incumbent may have overall responsibility for leadership and process expertise for specific Data Management technologies. The incumbent will also be involved in developing the longer term strategies for key data management 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.

• The Associate DM Systems Director is expected to provide expert consultation, advice and process & technology leadership to the multiple vendors supporting DM (up to 8) and to highlight any areas of risk to the DM Leadership team.

• The Associate DM Systems Director monitors KPIs and other key study metrics, to ensure alignment to DS and Development goals for key drug development projects

Organizational Context:

• Reports to Director, Data Management Systems.

• Participates in drug program level discussions, and contributes 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 DM Systems staff assigned to the individual projects/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., Data Manager, 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.

Qualifications:

Required

• BS or MS degree in Computer Science, Informatics, or life science discipline; minimum of 8 – 10 years in pharma or CRO industry in an informatics or programming role.

• Advanced experience using SAS, ORACLE and SQL.

• Advanced experience using Crystal Reports, Business Objects and other business intelligence tools.

• Demonstrated mastery of DM systems skills in multiple development programs, inclusive of all activities from program inception to regulatory submission.

• Mastery level understanding of relational database structure.

• Demonstrated experience in leading system selection and implementation projects.

• Regulatory submission experience

• 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 systems discipline.

• Strong computer skills, including database management software, reporting tools, medical coding tools, etc.

• Solid understanding of CDISC data standards.

• Seasoned expert with EDC and 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.

• 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

Preferred

• SCDM Certified Clinical Data Manager (CCDM) preferred.

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

• 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

#Li-SS

Category Data Science

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans