Director – Clinical Trial/CRO SME (Clinical Data Management & Customer Success)
Job Summary
Job Description
Seeking a Director-level Clinical Trial Subject Matter Expert (SME) with extensive experience in Clinical Data Management (CDM) and modern clinical data workflows and analytics. This role involves ensuring delivery excellence in customer engagements and supporting strategic sales and pre-sales efforts. The individual will be client-facing, requiring strong domain expertise, solution-oriented thinking, and a collaborative approach to help life sciences sponsors adopt and scale the Saama platform. Key responsibilities include guiding clients in optimizing clinical data workflows, providing clinical data oversight, acting as a domain advisor during audits, and translating client feedback into platform enhancements. Additionally, the role supports sales teams through client pitches, solutioning workshops, RFP responses, and conducting product demonstrations.
Must have:
- Bachelor's or Master's degree in Life Sciences, Clinical Research, Health Informatics, or related field.
- 12+ years clinical trial experience, 8+ years in CDM.
- Experience in customer-facing roles, including CRO experience.
- Strong knowledge of clinical data lifecycle and CRO workflows.
- Familiarity with clinical data programming logic and workflows.
- Prior exposure to SAS, R, SQL, or Python in clinical setting.
- Expertise in EDC systems (e.g., Medidata Rave, InForm, Veeva Vault).
- Proven ability to engage executive stakeholders.
- Strong communication, presentation, and interpersonal skills.
Good to have:
- Experience supporting/selling AI/ML, data analytics, or digital transformation solutions.
- Prior involvement in cross-functional solutioning.
- Familiarity with RWD/RWE integration, patient-centric data models, or external data sources.
- Previous experience contributing to platform development roadmaps and SaaS delivery.
Perks:
- Lead clinical transformation with cutting-edge AI solutions.
- Work directly with top-tier pharma/biotech companies.
- Collaborative, forward-thinking team.
- Competitive compensation.
- Flexible work environment.
- Global exposure.
9 skills required
Job Details
Description
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.
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