Clinical R&D Business Systems Analyst, IT
Who we are :
Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for genetically defined diseases - and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company's leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.
The impact you will make :
Agios Pharmaceuticals is searching for a dynamic Clinical R&D Business Systems Analyst (BSA) to join our growing IT team. We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities. The Clinical R&D Business Systems Analyst will be responsible for understanding our overall Clinical Development, Clinical Operations, Regulatory, Medical Safety, Biostatistics strategies, they will also serve as the strategic interface for the purpose of technology strategy execution between the IT organization and the functions listed above.
This is a hands-on role requiring strong internal partnerships with R&D teams to deliver innovative solutions that meet evolving business needs. The BSA will analyze and support the design of processes and guide the business in the comparison and selection of right-sized and intentional business systems. The BSA will have an in-depth understanding of how the business leverages current systems and data today, and how we can develop and enhance solutions that enable the organization to meet future business needs. This resource will need to be flexible and have general BSA skills, to assist on many diverse types of projects.
To accomplish this, we are looking for a business systems analyst who can :
- Perform the traditional functions expected of a Business Systems Analyst - document requirements, develop flow diagrams, and understand business processes and analyzing and streamlining the business processes.
- Act as a 'product manager' for their domain - going beyond simple requirements elicitation and help define solutions that anticipate future needs, leverage knowledge of industry trends, and future proof our investments.
- Create and execute test scripts and facilitate the UAT process, ensuring stakeholders understand capabilities, test complete solution and supporting data for user experience, and ensure solutions are easy to navigate and consume.
- In collaboration with IT Business Partner, serve as an interface between the IT organization and the business functionals SME.
- Interface with functional solution delivery team to translate customer requirements into detailed technical specifications to be used in the solution design and development process.
What you will do :
Work with the business SME to clearly define user requirements and translate the requirements into detailed functional requirements to be used in the solution design and development process and communicating delivery status to the business.Assist business SME team to prioritize enhancements using Agile methodology including backlog grooming and creation of user stories.Orchestrate full cycle delivery of IT applications in partnership with the solution delivery team and ensure successful change management, implementation (planning, execution, and delivery) and operational support.Create and deliver documentation required per established project implementation process for each phase of SDLC including but not limited to creating User requirements doc, system impact assessment, Test plan, Test scripts, traceability matrix, training plan, communications plan, end user guides, RAID logs, status reports, data migration plan, etc.Design and document operational workflows, the development and execution of the roll out strategies, end-user training and support, and end-user documentation.Collaborate with business SME, IT system owners and vendors to plan and execute quarterly release and upgrade management and associated business critical regression testing.Develop test scenarios and test cases, including execution of unit testing and facilitate UAT.Assess new opportunities for IT solutions and utilization to further drug development efforts, and initiate projects and efforts accordingly.Identify opportunities for functional improvements and enhancements to maximize the effectiveness of available technology. Act as business SME for technical development staff in all phases of the development and implementation process.Troubleshoot critical production issues through discussion with end users, managed service vendor and operations team. Includes problem triage / recognition, research, and isolation and resolution steps.Working knowledge of project management methodologies. Manage project deliverables per Agios SDLC. Collaborate with Program Management Office (PMO) for process and status reporting on key project deliverables and milestones.Interact and support Clinical R&D systems including and not limited to CTMS, eTMF, EDC, IRT, RIM, Clinical Data Warehouse, Pharmacovigilance / Drug SafetyWhat you bring :
BS (Computer Science / Computer Engineering / Systems Engineering) or a related technical discipline or equivalent combination of education, technical training or work experience.Strong background in implementing and supporting GxP systems and computer systems validation process and documentation.6 to 8 years of related successes with in-depth knowledge of key Clinical systems such as Veeva Vault, SAS, Medidata and Argus platforms (or their competitors).Experience in pharmaceutical / biotechnology and an understanding of clinical trials operations and regulations including FDA, MHRAWell versed in GAMP 5 and Computer Systems AssuranceDemonstrated ability to analyze complex issues, to develop relevant and realistic recommendations and plans, and to drive projects to consistently meet deadlines.Good listening skills with ability to make timely well-informed decisionsEffective communicator (written and oral) across all levels of organization, including users, developers and line level management in multiple time zones.Knowledgeable about Software Development Life Cycle (SDLC) models.Must communicate clearly and effectively with both technical and non-technical stakeholders.Skilled in active listening ensuring mutual understanding and alignment across all levels of organization.Ability to solve complex problems with critical thinking and analysis and make compelling and persuasive presentations to win approval for recommendations.Ability to listen and collaborate with clients to generate forward-thinking innovative solutions that deliver practical and sustainable results.Work independently with minimal supervision with demonstrated experience working in a matrix environment.Strong ability to troubleshoot issues independently, prioritizing tasks effectively while managing high quality deliverables.Strong team player that has a customer service approach and is solution oriented.Experience with vendor management and oversight of data exchange, migration, and integrationPreferred Qualifications
Bachelor's Degree with PMP or Master's degree.Consulting background with recent client facing experience.Recent experience in Life Sciences with flexibility to adapt to the dynamic needs of a growing pharmaceutical company and to manage change effectively.Experience with implementing and supporting regulated systems RIM, CTMS, eTMF, Drug Safety in an organization with multiple business units / entities.Experience managing complex projects and integrations across multiple modules in a platform and standalone systems.Experience with Veeva Vault platform, Oracle Argus, Egnyte, SAS, RStudio, RAVE EDC, Elluminate, Spotfire.Work Location :
Location Agnostic : Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events / meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.
What we will give you :
Deliberate Development. Your professional growth as one of our top priorities.Flexibility. We're all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you're at your best, we're at our best.Premium benefits package. We invest in the health, wellbeing and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We're continuously looking to improve the inclusivity of our workforce.Commitment to community. We're an active participant in the communities that surround us - the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.
