Pillar 1 - Clinical Data Operations
You are accountable for the end-to-end execution quality of all CDM activities across Clinfocus studies. That means:
• Study Execution Ownership: Drive every phase of CDM — EDC build and validation, CRF design, edit check specification, SAE reconciliation, query management, medical coding (MedDRA/WHO Drug), database lock, and CDISC-compliant data package delivery. You do not just oversee these; you are the accountable owner.
• Inspection Readiness: Every document, decision trail, and data artefact must be audit-ready at all times, not just before a milestone. Treat every study as if an FDA or EMA inspector is arriving next Monday.
• Technology & Automation: Configure, optimize, and champion CDM platforms (EDC, eCOA/ePRO, eSource, RTSM, CDMS). Identify manual steps that can be automated and build the business case for doing so. We invest in tools that eliminate rework.
• Vendor and Stakeholder Management: Own relationships with CDM vendors and CROs: negotiate SoWs, manage SLAs, escalate performance issues, and keep projects on budget. Translate technical CDM status into clear communication for sponsors and clinical leadership.
• Metrics That Matter: Define, track, and report CDM KPIs: cycle times, query rates, first-pass quality, data entry lag, database lock timelines. If a metric is drifting, you diagnose it and fix it — do not just report it.
PILLAR 2 — Quality Systems & Compliance
You are the quality function at Clinfocus. There is no separate QA department. You build and maintain the system that guarantees we are always compliant and always improving:
• SOP Architecture: Author, version-control, and maintain all CDM and operational SOPs, Work Instructions, and policy documents. SOPs must be clear, actionable, and actually followed — not filed and forgotten.
• Regulatory Compliance: Ensure all CDM and operational activities adhere to GCP (ICH E6/E8), 21 CFR Part 11, GDPR/DPDPA, CDISC (CDASH, SDTM, ADaM), and applicable regional regulations. Flag risks before they become findings.
• Quality Gates & CAPA: Implement quality checkpoints across study milestones. Own the CAPA process: when deviations or non-conformances occur, lead root cause analysis, document corrective actions, and verify effectiveness — do not delegate the close-out.
• Audit & Inspection Readiness: Lead internal audits and readiness assessments. Act as the primary point of contact during sponsor audits or regulatory inspections. Zero critical findings is the standard, not the aspiration.
• Training Program: Build and maintain the CDM and GCP training program for all staff and onboarding new hires. This includes curricula design, role-based learning paths, assessment tools, and effectiveness metrics. Training must change behavior, not just satisfy a checkbox.
• Risk Management: Maintain a living operational risk register. Identify regulatory, process, and data risks proactively and bring mitigations to leadership before they escalate.
ACROSS BOTH PILLARS — Startup Responsibilities
In addition to the two core pillars, you will be expected to:
• Improve and expand what exists — we have a functional operational and quality foundation built over six years. Your job is to assess it honestly, strengthen what is working, retire what is not, and build the additional infrastructure required for larger and more complex contracts.
• Contribute to business development — support proposal writing, capability decks, and client conversations where your CDM or quality expertise is needed.
• Hire and develop the team — as we grow, you will define the team structure beneath you, interview candidates, and mentor junior hires.
• Report directly to the CEO — bring clear data, clear problems, and clear recommendations. We move on facts, not instincts alone.
• We are building a company that is rigorous, direct, and relentlessly focused on quality. You set that standard by example.
REQUIRED QUALIFICATIONS
Non-Negotiable Requirements
• 8+ years of hands-on Clinical Data Management experience in a CRO, biotech, or pharmaceutical environment.
• Demonstrated end-to-end ownership of at least 3 studies through database lock, including at least one Phase II or III trial.
• Proven experience writing and managing SOPs, deviation handling, and CAPA processes in a GCP-regulated environment.
• Deep working knowledge of ICH E6(R3)/E8(R1), 21 CFR Part 11, CDISC standards (CDASH, SDTM), and GDPR/DPDPA.
• Hands-on EDC platform experience (Medidata Rave, Veeva Vault EDC, Oracle InForm, or equivalent) — not just oversight experience.
• Ability to operate independently with minimal direction and manage competing priorities without escalating every decision.
Strongly Preferred
• Bachelor's degree in Life Sciences, Health Informatics, Pharmacy, or a related field; Master's or CDM-relevant certification (CCDM, RAC) is advantageous.
• Experience in a growth-stage or mid-size CRO where you have both inherited existing processes and driven meaningful improvement programmes across quality and operations.
• Familiarity with eCOA/ePRO platforms, RTSM, and eSource data capture.
• Experience leading or contributing to sponsor audits or regulatory inspections.
• Exposure to clinical data review, statistical data standards, or basic SDTM mapping.
• Working knowledge of project management tools (Smartsheet, Jira, Asana, or similar).
