Description

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

Education

Any Graduate