Clinical Business Analyst - Epista US

At Epista, we don’t hire generalists and hope they become clinical. We hire clinical experts who already understand how trials run—and we sharpen them into elite consultants.

We are a Life Sciences consulting firm focused on clinical, regulatory, and compliance excellence. Our clients are global pharma and biotech organizations running complex clinical programs—and they expect precision.

If your experience in clinical operations is surface-level, this is not the role.

If you’ve lived inside clinical systems, understand how trials actually operate, and can translate that into structured delivery—we should talk.

You will operate as a Clinical Domain Consultant first, Business Analyst second. You’ll work directly with clients to analyze, design, and optimize clinical processes and systems across the trial lifecycle.

CORE RESPONSIBILITIES: This role is clinically anchored. We are not looking for pure IT BAs or generic consultants.

Clinical Operations & Process Excellence

• Assess real-world clinical workflows across study start-up, conduct, and closeout
• Identify breakdowns in execution, compliance, and data integrity
• Translate clinical operations into structured business and system requirements
• Design scalable, compliant processes aligned to GxP expectations

Clinical Systems & Data

• Work hands-on with clinical platforms (eTMF, CTMS, EDC, eCOA/ePRO, IRT)
• Support implementation, optimization, and integration of clinical technologies
• Ensure alignment to CDISC standards and clinical data governance frameworks
• Drive data quality, reconciliation, and inspection readiness

Client Delivery

• Serve as a trusted advisor to clinical stakeholders (Clin Ops, Data Mgmt, QA)
• Lead workshops, gather requirements, and translate complexity into execution
• Communicate clearly with both business and technical teams

Strategic Impact

• Contribute to clinical transformation initiatives
• Align clinical operations with business outcomes, timelines, and regulatory expectations
• Support business development through credibility and domain expertise

Required Experience

• 3–5+ years in clinical operations, clinical systems, or clinical consulting
• Direct experience working within clinical trials (sponsor, CRO, or consulting)
• Hands-on exposure to at least two of the following:
• eTMF / CTMS
• EDC systems
• ePRO / eCOA
• IRT / RTSM
• Strong understanding of clinical workflows, documentation, and compliance requirements

Technical & Analytical Strength

• Ability to translate clinical processes into system and data requirements
• Experience with clinical data standards (CDISC)
• Strong analytical mindset with the ability to interpret and structure data

Consulting Readiness

• Comfortable working directly with clients in ambiguous environments
• Able to structure problems, communicate clearly, and drive outcomes
• Proven ability to balance detail (compliance) with speed (delivery)

Preferred Experience

• Veeva Vault (eTMF, CTMS)
• Medidata, Oracle Clinical, Siebel CTMS
• TransPerfect or similar platforms
• Experience supporting inspections or audit readiness

Education & Certifications

• Bachelor’s degree in Clinical, Life Sciences, Biotechnology, or related field
• Certifications such as CBAP, PMP, CPHQ, or Veeva are valued—but secondary to real clinical experience

WHAT MAKES THIS ROLE DIFFERENT

As an Epista Clincial BA, you’ll be working at the intersection of compliance and business as a part of our highly skilled and dedicated team. You’ll be involved in a wide variety of projects in the Clinical Domain and much of your time will be spent with our clients - international pharma and medical technology companies. Your daily activities might include:

What Makes This Role Different

• You won’t be “taking notes”—you’ll be solving clinical problems
• You’ll work in environments where compliance is real, not theoretical
• You’ll be part of a team that values expertise, trust, and measurable outcomes

At Epista, our standard is simple:

If it doesn’t improve clinical execution, it doesn’t matter.

#BeingEpista Our team is our differentiator. We operate with:

• Recognized Expertise
• Trustworthy Conduct
• Measurable Results
• Lasting Relationships

If you bring clinical depth, we’ll give you the platform to it at the highest level.

This role is likely a strong fit if:

• You’ve worked directly on clinical trials and understand how they actually run
• You’ve used clinical systems—not just heard of them
• You can move from clinical detail structured solution client delivery

This role is not a fit if:

• Your experience is primarily IT, product, or generic BA work
• You’re looking to “break into” clinical
• You need heavy direction to structure your work

Epista is a team of pioneers. We unlock each consultant’s potential to continuously improve.

Our #BeingEpista unique team spirit makes a positive impact – on our clients and the Life Science industry. Here, you’re never alone. We all work together for everyone’s success. And each individual is strengthened by the knowledge of the group.

We’re proud to be Epista, for good reason. are you ready to join us?

Epista is an equal opportunity employer and value diversity. All employment is decided on the basis of qualifications, merit and business need.