TMS
Location
Bridgewater, NJ | United States
Job description
We are seeking a technical functional lead/developer with Veeva 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
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
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