Director – Clinical Trial/CRO SME (Clinical Data Management & Customer Success)

United States

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Saama

Saama automates key clinical development and commercialization processes, with artificial intelligence (AI), machine learning (ML) and advanced-analytics, accelerating your time to market.

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Director – Clinical Trial/CRO SME (Clinical Data Management & Customer Success)Location: RemoteDepartment: Customer Success Role OverviewWe are seeking a Director level Clinical Trial Subject Matter Expert (SME) with deep expertise in Clinical Data Management (CDM) and a modern understanding of clinical data workflows and analytics. This individual will play a critical dual role in ensuring delivery excellence across customer engagements and supporting strategic sales and pre-sales efforts.
This is a highly visible, client-facing position that requires strong domain expertise, solution-oriented thinking, and a collaborative mindset to help life sciences sponsors adopt and scale the Saama platform across clinical trials. Key ResponsibilitiesCustomer Success & Delivery
  • Serve as the senior CDM SME during customer onboarding and implementation of the Saama platform and analytics solutions.
  • Guide clients in optimizing clinical data workflows – including ingestion, standardization, mapping, reconciliation, and data readiness.
  • Ensure platform configuration and data integration align with clinical operations, programming, and regulatory needs.
  • Provide clinical data oversight during ongoing platform usage, issue resolution, and continuous improvement.
  • Act as the primary CDM domain advisor during audits, reviews, and executive client interactions.
  • Translate client feedback and emerging data needs into platform enhancement recommendations.
 Sales & Pre-Sales Support
  • Support business development and sales teams by contributing to client pitches, solutioning workshops, and RFP responses.
  • Conduct product demonstrations, workshops, and discovery sessions from a clinical data domain lens.
  • Identify business pain points and articulate the clinical and operational value of the Saama platform and its AI-enabled capabilities.
  • Serve as a strategic partner in developing tailored proposals and positioning statements for pharma and biotech sponsors.
  • Represent Saama at industry conferences, panels, and webinars to establish thought leadership and visibility
 Required Qualifications
  • Bachelor’s or Master’s degree in Life Sciences, Clinical Research, Health Informatics, or related field.
  • 12+ years of clinical trial experience, with 8+ years in Clinical Data Management and several years in customer-facing roles, including prior experience working with CROs.
  • Strong knowledge of the clinical data lifecycle and end-to-end CRO workflows, including eCRF design, query management, data standards (CDISC SDTM/ADaM), and regulatory expectations (ICH-GCP, FDA 21 CFR Part 11).
  • Familiarity with clinical data programming logic and workflows (edit checks, derived variables, mapping).
  • Prior exposure to SAS, R, SQL, or Python in a clinical setting (not necessarily hands-on currently).
  • Expertise in working with EDC systems such as Medidata Rave, InForm, or Veeva Vault.
  • Proven ability to engage executive stakeholders in pharma/biotech.
  • Strong communication, presentation, and interpersonal skills in a sales-support or consulting environment.
 Preferred Qualifications
  • Experience in supporting or selling AI/ML, data analytics, or digital transformation solutions in clinical development.
  • Prior involvement in cross-functional solutioning with product, data science, and engineering teams.
  • Familiarity with RWD/RWE integration, patient-centric data models, or external data sources (e.g., imaging, genomics).
  • Previous experience contributing to platform development roadmaps and SaaS solution delivery.
 Why Join Saama?
  • Lead clinical transformation with cutting-edge AI solutions in life sciences.
  • Work directly with top-tier pharma/biotech companies to accelerate trial outcomes.
  • Be part of a collaborative, forward-thinking team bridging science and technology.
  • Competitive compensation, flexible work environment, and global exposure.


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Tags: CDISC Consulting Data Analytics Data management Engineering GCP Machine Learning Pharma Python R Research SAS SQL

Perks/benefits: Competitive pay Conferences Flex hours

Region: North America
Country: United States

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