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Astellas Pharma Senior Manager, Clinical Data Digital Health Lead 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 and Scope:

This Clinical Data Digital Health Lead is a technical leadership position, accountable for the definition, oversight, and operational execution of Data Management (DM) deliverables for the Data Science (DS) Digital Health Technology (DHT) strategy. The DS DHT Strategy includes clinical study and program level deliverables for the Astellas' Decentralized Clinical Trials (DCT) initiative and digital health technologies and tools such as wearables, Electronic Health Records (EHRs), applications (apps) etc. This role's focus areas include:

  • Operational lead for Digital Health Technologies (DHT Lead) for clinical study and program level implementation including defining study needs and challenges, establishing study level dataflow, supporting team in building and mapping technology, technology deployment, maintenance and closeout.

  • Ensuring DHT operational excellence, global regulatory compliance and technology vendor oversight.

  • Execution of DS DHT strategic plan to drive business transformation through novel data strategies, digital innovation approaches leveraging new clinical data flow opportunities. Supports the implementation of new organizational capabilities such as eSource via pilots (e.g., EHR to DCT platform, digital health (wearables) etc.).

  • Process owner for DHT operations including day-to-day technology vendor oversight as Business Subject Matter Expert.

  • In collaboration with DS Clinical DHT Director and IS function, develops and facilitates process automation opportunities in DM Innovation strategic initiative.

  • Provides training on technology to enable adoption.

Essential Job Responsibilities:

  • Execution of DS DHT strategy's operational plan. This includes design, creation and management of study and program level DHT workflows, digital data flows, remote data collection, data transfer, data integrations and data storage within a DCT platform or as a stand-alone digital health technology.

  • Coordinates cross-functionally for DHT implementation and in collaboration with the Clinical Science DCT Center of Excellence and portfolio asset teams for advisory and hands-on study team support.

  • Provides operational oversight for data management system vendors and solutions (e.g., DCT platforms, eSource, and external data). 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.

  • Has a comprehensive understanding of clinical data standards (i.e., CDISC, HL7), and represents data standards interests with key stakeholders and study teams.

  • Maintains best practices, operational playbooks, guidance documents, SOPs, work practice documents, tools, databases, and standard templates for DHT.

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

  • Develops relationships with vendors to maximize the benefit for Astellas and increase operational efficiencies. Ensures that DHT vendor working practices are in alignment with Astellas expectations (e.g., SOP reviews, new vendor selections, QA audit representative).

  • May lead the operational governance discussions with key DM/DHT/eSource technology vendors as the Astellas DHT operational 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:

  • This position is assigned to multiple drug-development programs and acts as the DM DHT Lead for all studies within those programs at the study level, globally.

  • Depending on business need, the incumbent may have overall responsibility for leadership and process expertise for specific Data Science roles/technologies (e.g., DCT, eSource). The incumbent will also contribute to longer-term strategies for key data management roles/technologies.

  • The incumbent is expected to provide expert consultation, advice and process & technology leadership to the multiple vendors (up to 15) supporting DM and DHT and to highlight any areas of risk to the DM Leadership team.

  • This role is also responsible for monitoring 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 within the DM Solutions team.

  • 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 across multiple drug programs.

  • Closely collaborates with cross-functional study team members (e.g., Lead DM, GDOL, Study Manager, Clinical Programmer, etc.) or other cross-functional staff such as Procurement, Quality Assurance, and IS staff as appropriate.

  • Interacts with counterparts globally and is expected to provide focused support to all global DM team members, as driven by business need.

Qualifications:

Required

  • BS/BA degree in a biological science, health-related or computer science field.

  • 8+ years related experience in pharmaceutical, clinical research or health services industry with a minimum of 5 years relevant experience in the clinical development discipline.

  • Seasoned expert with DHT solutions (eSource, wearables, EDC, and/or eCOA systems/devices), including implementation of such systems.

  • Demonstrated mastery of relevant skills (e.g., clinical, data management, biostatistics) in multiple drug development programs, inclusive of all activities from program inception to regulatory submission.

  • Active contribution to inspections and major (vendor) audits. Solid knowledge of international regulations for clinical trials (e.g. GCP).

  • Strong cross-functional understanding of processes of data management, clinical programming, biostatistics and clinical.

  • Solid understanding of CDISC and other associated industry level data standards.

  • Excellent verbal and written communication skills.

  • Proven ability to work with and influence individuals across multiple disciplines and organizational levels in international environment.

Preferred

  • Professional certification in a Clinical Development discipline.

Benefits:

  • Medical, Dental and Vision Insurance

  • Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down

  • 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

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

EOE including Disability/Protected Veterans

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