Astellas Pharma Information & Systems Strategy Manager in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company. Astellas is announcing an Information & Systems Strategy Manager opportunity in Northbrook, IL.
Purpose & Scope:
Operational Improvement & Reporting Excellence is a leader in aligning functions across M&D organizations in areas which impact quality management; process management; non-drug initiative management, including IT components, to support business strategy; business information reporting and analytics; resource management; and learning and development. As the Associate Information & Systems Strategy Director this position will be accountable for leading specific business support processes and strategic oversight of complex information systems utilized within M&D through collaborative partnerships with cross-functional stakeholders in M&D and IS.
This position is responsible for leading small to medium sized clinical systems projects. This could include managing medium-touch systems or managing a suite of smaller applications. The Information and Systems Strategy Manager will be the system content expert for one or more systems and will have knowledge of other systems in order to assist the larger BIRA team.
Essential Job Responsibilities:
- Work with the leadership in the development of systems specific strategy and goals
Provide project management for assigned clinical system projects including responsibility for all phases of the project
Analyze and manage User Requirement and system change requests and coordinate user acceptance
- Develop detailed project plans and manage project timelines and budget as appropriate
- Ensure adequate resources are assigned in support of project/system including coordination of consultants
- Accountable for on-time delivery within budget constraints, in collaboration with IS R&D Partners (RDP) and other key stakeholders
- Manage system upgrades, integrations, releases and decommissioning
- Ensure deployment of system or new releases/upgrades including the timely delivery of project communications to end users and key stakeholders
- Develop and execute a comprehensive communication and change management plan
Provide system support in partnership with RDP and other business functions and where appropriate:
Manage and solve user issues, communicate issues to vendor (incident and change management)
- Interface with stakeholders to ensure study system builds result in interfaces being set up appropriately
- Ensure the effective use of systems and compliance with internal and external requirements
- Liaises with business process owner, systems trainer and help desk support to ensure system feedback loop
- Support internal and external Astellas users within OIRE
- May deliver end user training and train-the-trainer sessions as appropriate
- Responsible for system vendor relationship management as appropriate
- Responsible for ensuring system compliance and management of the help desk.
- Responsible for budget and timelines associated with assigned system and associated initiatives.
- May provide oversight and management of vendors or contractors working on a project, as applicable.
- The position reports to the Sr. Manager or Associate Information & Systems Strategy Director.
- The position may oversee outsourced and/or junior support staff.
- The position will work closely with other functions within Operational Improvement & Reporting Excellence support any gaps or improvements needed in the data model or reporting procedures for the system(s) assigned.
- The position works cross-functionally with other Astellas groups to develop and implement excellence in business and clinical operations.
Minimum 7 years in the pharmaceutical industry and/or management consulting group focused on R&D or clinical operations, with minimum 2 years in the drug development setting.
- Previous experience in the development, deployment, and/or maintenance of clinical information systems (IVRS, CTMS, etc.)
- Experience in Software Development Life Cycles including requirements/specifications development and/or user acceptance testing for computer systems
- Proficient project management and timeline management skills; ability to successfully manage a single project and associated tasks and manage risks
- Basic presentation and communication skills, negotiation and follow-up skills
- Ability to interact and network effectively with internal customers and external vendors
- Dedication to customer service, and experience delivering on customer needs
- Basic understanding of available business and clinical databases within Astellas
- Knowledge of the Pharma Development business process and conduct of Clinical Trials
- Forward thinking and creative solution development
- Attention to detail
- Works well individually and demonstrates good people/team skills
- Training in Regulatory and System Compliance
- Applied GXP experience in pharmaceutical or biotechnology industry with clinical drug development experience
- Knowledge of ICH and GCP required
- Proficient computer skills across multiple applications
- Fluency in written and spoken English
- Position may require domestic and international travel
- Location for this position is Northbrook, IL, Leiden, Netherlands or Tokyo, Japan
- Minimum 1 years of people management experience, preferable in a highly matrixed, multicultural global setting.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Planning and Administration