IT Manager - Clinical Systems

Company: Ascendis Pharma A/S
Location: Palo Alto
Posted on: February 19, 2021

Job Description:

Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs? Then Ascendis Pharma is committed to supporting your professional development on our journey.Ascendis Pharma is looking to hire an experienced IT Manager - Clinical Systems to join our team. This is an exciting opportunity to join a rapidly growing, innovative company!Position SummaryThe IT Manager role is part of a team that plans, develops, implements, manages, maintains, and supports various business applications and systems. The individual in this position is responsible for the management of one of more projects and/or programs involving cross functional stakeholders globally. The position will be based in Palo Alto and will report directly to the Head of US IT.Key Responsiiblities* Serve as the Manager for IT Systems enabling clinical business processes with technology platforms such as Veeva Vault, Omnicomm, Medidata, etc.* Mature Ascendis' Clinical Informatics capabilities such as TMF, CTMS, IRT, eCOA, EDC, LIMS, Clinical Supply Chain, etc.* Leads cross-functional project teams and works with business process owners to determine and translate business requirements into technology solutions. This includes responsibility for planning, directing and coordinating projects from initiation through to implementation.* Accountable for the delivery of the software solution including processes, requirements and configurations surrounding the use of system; including regulatory (GxP) compliance, where applicable.* Coordinates communication within the project team, escalates and facilitates the resolution of risks, issues, and changes.* Develops Requests for Proposals (RFPs) and leads the team to establish vendor and application selection criteria; coordinates vendor demonstrations, leads the vendor selection process and acts as the vendor's point of contact for the project.* Effectively interfaces and communicates with senior management and all key stakeholders regarding project deliverables, project status, risk identification/mitigation, issue management and budget spend.* Oversees all phases of solution implementation and the corresponding project and quality documentation to ensure adherence to budget, schedule and scope.* Provides on-going project management support to plan, prioritize and deliver system enhancements.* Develops high-level and detailed project plans and ensures that the scope and approach are fully understood by all stakeholders.* Actively manages project costs, resources, change requests, risk and issues to ensure maximum business benefit.* Follows Project Management Institute (PMI) methodology and best practices for project management; helps develop standards, processes around project management, prioritization, and portfolio management.* Functions as a liaison between the business and IT for those business units they have been assigned to manage projects, and other organizations/teams/functions throughout the business. This includes helping build strategy, functionality, acting as an SME, and helping to escalate issues to IT Service Management and the IT Service Desk.* Maintain an up-to-date knowledge on latest process optimization technologies and compliance regulations within the pharmaceutical industry.* Play a key role on the IT PMO to contribute towards efforts to mature project management methodology at Ascendis.* To coordinate and manage continuous improvement of IT Systems and processes across Ascendis.* Facilitates workshops and translates user needs into user requirements and use cases.* Work closely with solutions architect to identify the optimum combination of applications that meet the requirements of business functions.* Manage a team responsible for the implementation and maintenance of system capabilities and/or upgrades.* Contribute to the support and maintenance of validation package in compliance with validation/documentation procedures as per SDLC methodology.* Contribute to the support and maintenance of operational documentation including SOPs, work instructions, manuals, and training materials for end users and system administrators.Requirements* Minimum level of education and years of relevant work experience:* Bachelor's degree in a related discipline and a minimum of 7 years of progressively responsible experience in related roles (including a minimum of 3 years of demonstrated IT project management experience) in a pharmaceutical, biotechnology or related environment.* Experience preparing and presenting summary information and proposals to senior leadership.* Special knowledge or skills needed and/or licenses or certificates required:* Project Management Professional (PMP) Certification.* Direct and demonstrated IT project management experience including experience leading large, complex, enterprise-wide, transformative projects.* Hand-on experience in Agile methodology.* Expert experience identifying, developing, customizing and implementing vendor software, particularly Software As A Service (SaaS).* Hands-on experience with one or more of the following: Research and Development (R&D) technologies, Document Management Systems (DMS).* Proficiency with Microsoft Office (including extensive/applied experience using MS Project).* Excellent verbal and written communication and skills.* Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.* Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.* Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.* Demonstrated experience leading cross-functional teams* Advanced PowerPoint and Excel capabilities* Travel requirements: 5% - 10%Benefits* Medical insurance* Vision insurance* Dental insurance* 401(k)* Paid maternity leave* Paid paternity leave* Commuter benefits* Disability insurance

Keywords: Ascendis Pharma A/S, Palo Alto , IT Manager - Clinical Systems, IT / Software / Systems , Palo Alto, California