Location

Remote (must overlap with EST business hours)

Contract Type

B2B Contract

Compensation

Gross salary (to be specified)

Holidays

10 public holidays per year
Vacation and sick leave are unpaid

About the Role

We are seeking a Senior Business Analyst to support the integration of regulated documents from Veeva Vault into our internal data lake. You will bridge the gap between clinical/regulatory stakeholders and the data engineering team, ensuring that document ingestion, metadata, and governance requirements are clearly defined, tracked, and implemented.

You will be responsible for requirements gathering, process mapping, and validation of data pipelines to ensure compliance, traceability, and usability of critical study, protocol, and submission documents.

Responsibilities

• Collaborate with stakeholders (Clinical, QA, RIM) to understand document workflows, lifecycles, and regulatory requirements.

• Define business and functional requirements for document ingestion, metadata capture, and traceability.

• Work with technical teams to ensure:

  • Incremental extraction of new/updated Veeva documents

  • Metadata capture (vaultId, documentNumber, versionId, lifecycleState, lastModifiedBy, checksum)

  • Auditability and compliance in storage and processing

• Create process flows, use cases, and user stories for Veeva Vault integration.

• Validate that technical solutions meet business needs, including:

  • Bronze/Silver data layers in S3 / Databricks

  • Event-driven metadata (Kafka)

  • Optional text extraction/indexing

• Document policies, SOPs, and compliance artifacts for regulated data handling.

• Act as a liaison between business and technical teams, ensuring clear communication and delivery alignment.

Required Qualifications

• 7+ years of experience as a Business Analyst in regulated industries (pharma, life sciences, clinical trials preferred)

• Hands-on experience analyzing workflows in Veeva Vault (QA Docs, Clinical, RIM)

• Strong knowledge of regulated data governance, document lifecycle, and compliance requirements

• Experience writing functional requirements, user stories, and process flows

• Understanding of data pipelines, metadata, and audit requirements (S3, Kafka, Databricks is a plus)

• Strong communication and stakeholder management skills

• Ability to work remotely during EST business hours

• B2B contract experience preferred

Nice to Have

• Exposure to AWS data lakes and data cataloging concepts

• Familiarity with text extraction / search indexing (Textract / OpenSearch)

• Prior experience in clinical trial submissions or regulatory operations

What We Offer

• Remote work with EST overlap

• Engagement in high-impact regulated data initiatives

• Clear role bridging business and technical teams

• Exposure to modern data lake architecture in a regulated environment