Principal Application Specialist
Principal Application Specialist
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Job Description
- Collaborate and lead the technical architecture discussions for Research and development clinical applications i.e CTMS eTMF Clinical Trial Transparency and Reporting tools.
- Assess the technical dependency resourcing risks integration upgrade data & data center migration for clinical applications.
- Requirement assessment analysis development and resource planning for integration of new business requirements.
- Coordination between business teams internal and external technology teams facilitate troubleshooting for complex technical issues conduct POCs and provide solutions.
- Provide inputs to project planning timeline and resourcing.
- Responsible to ensure all the applications are compliant as per industry and organizational needs and processes (GxP SOPs SDLC etc.
- Engage and support MSP staff as required in daytoday operations.
- Drive clinical application migration enhancement development retirement and ensure organizations process followed.
- Participate in enterprisewide IT initiatives (i.e. IT Security Platform Upgrades Infrastructure update and upgrades) evaluate and plan the impacts on clinical systems aligned the support team and contribute to its success.
- Work with SaaS vendors to identify issues fix them timely and address any security related issues. Maintain a good relationship with the SaaS vendors.
- Create review approve and maintain an informational IT knowledge base containing documentation of applications policies procedures infrastructure and other critical technology assets.
- Establish application SOP. Runbook and Work Instruction documents and ensure support team follows change management processes.
- Provide technical assistance to support analysts for managed applications.
- Ensure routine maintenance tasks and system administrative activities are running smoothly to maintain reliable and effective operation of all applications.
- Drive the implementation of the IT vision and strategy for R&D.
- Participate in problem resolution related to clinical application issues across business units and regions which includes working with business colleagues businessfacing IT colleagues infrastructure teams external partners and/or vendors.
- Drive the implementation of the IT vision and strategy for R&D.
- Work with BA and IT System Owner on projects such as application upgrade patching and enhancements.
- Lead and prepare support go live for all project and ensure the project to support transition occurs smoothly.
- Manage production deployment of application patches and upgrades including communications to users.
- Ensure change management processes are continuously followed to maintain a stable production environment.
- Sustain Software Development Life Cycle (SDLC) management through routine systems health assessment maintenance of highquality documentation and real time license management.
Position requires travel 5 100 domestic travel and 0 international travel).
May telecommute up to 30.
Qualifications :
Minimum Requirements:
Employer will accept a Bachelors degree (or foreign equivalent) in Computer Science or related field and 10 years of experience in the job offered or in a Principal Application Specialistrelated occupation.
- 7 years of experience in the field of Information Technology.
- 4 years of experience in R&D IT working in Biotech Company.
- 4 years of experience in working in onshore/offshore environment.
- 3 years of experience working with Pharmaceutical GxP environment.
- 3 years of experience in working and supporting on CTMS eTMF and reporting tools R&D Clinical applications.
Salary: $172744/year $183500/year
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver lifechanging medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an EVerify Employer in the United States.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
