Job Description :
Veeava Clinical Vault experience who has hands-on knowledge with Veeva CTMS. Candidate should have a deep understanding and knowledge of CTMS application migration (preferably: Calyx/Parexel IMPACT CTMS to Veeva CTMS), integration, and managing system configurations, with an understanding of the database and clinical studies operational datasets
Responsibilities:
• Drive technical discussion related to the Veeva Vault technologies related to clinical R&D applications
• Define, author, and present various architecture footprints i.e. Business, Logical, Integration, Security, Infrastructure, etc.
• Engage and provide support for the migration activities of the legacy CTMS system to Veeva CTMS (e.g. data/filed mapping, etc.)
• Define integration design by engaging Veeva technical team
• Engage the required team for review and approval of the proposed design
• Work and drive software vendor to perform various technical activities and documents following the SDLC process
• Adhere to Biogen SDLC methodology/process on authoring various technical deliverables
• Attention to detail and providing detailed documentation required in a 21 CFR validated environment
• Support project manager in best software implementation practices
• Responsible for all technical delivery that includes scheduling meetings with required individuals/groups
• Active participation in various meetings providing technical thought process
• Create support transition-related documents
• Ability to see the bigger picture and raise/escalate any concern/issues before becoming a bottleneck
Key Skills
• Experience in Clinical Trial Management Systems preferably Veeva CTMS or Calyx/Parexel IMPACT CTMS
• Understanding and Experience working on various architecture footprints e.g. Integration, Security, Infrastructure, etc.
• Knowledge of defining various Data flow model
• Experience with various AWS Cloud-related tools, e.g. storage, compute, etc., and implementation methodology
• Good understanding of Identity and Access Management protocols and technologies: OAuth, OpenID Connect, SAML, Federation, SSO such as OKTA.
• Knowledge of Single-Sign-On using OKTA is preferred
• Knowledge of various integration architectures and protocols: API Gateway, SOA, REST, XML, sFTP, MFT, WSDL, and SOAP.
• Working knowledge on the use of Active Directory group, permissions
• Understanding of network architecture, VPN, MPLS, Cloud to On-Prem network
• Knowledge of Oracle, and Postgres databases with Unix/Linux commands
• Strong experience with Relational database/Data Access -- RDBMS, tables, triggers, logical and physical modeling.
• Working knowledge of SDLC methodology/process, various deliverables, and authoring various technical SDLC deliverables
• Possess excellent problem-solving skills using creative approaches.
• Ability to work effectively with cross-functional engineering teams and business partners.
• Excellent written and verbal communication skills
Any Graduate