Technical Lead III / Veeva Vault Tech Functional Lead/Developer

Duration: 8+ Months (40hrs/weeks)

Application Design, Architecture and Development experience in Biotech/Pharma industry. IT Development/Technical management experience. Experience working with outsourced service providers a plus. Experience working with offshore delivery teams a plus. Excellent written and communication skills; consultative skills and mentality; good listening skills with ability to make timely well-informed decisions; ability to translate business requirements and architecture designs into system designs; ability to track project activities and track progress to business value realization, escalating where necessary, hands-on experience configuring, validating, and supporting Documentum, eTMF, CTMS, clinical data management systems, and drug safety systems.

Requires bachelor’s degree in information technology, Computer Systems and 6+ years of experience.             

We are seeking a technical functional lead/developer with Veeva Clinical Vault experience who has hands-on knowledge of 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 Client 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

Shift:

1st   Shift (M-F)