Director – Clinical Trial/CRO SME (Clinical Data Management & Customer Success)
Location: Remote
Department: Customer Success
Role Overview
We 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 Responsibilities
Customer 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.