About ClinFocus

ClinFocus is a data-first contract research organization (CRO) and clinical intelligence company that leverages AI to automate clinical data workflows across the trial lifecycle. Operating in a regulated environments, ClinFocus delivers end-to-end biometrics services   from data management and statistical programming to medical coding and clinical systems development   with a commitment to quality, speed, and regulatory compliance.

Our team works on complex, high-stakes trials across oncology, rare disease, and neurology, and we are scaling rapidly to meet growing demand from biotech and pharmaceutical sponsors.

Role Overview

The Senior Manager, Biometrics Operations is a critical leadership role responsible for overseeing clinical data management and biometrics operations. Reporting directly to the VP/Head of Biometrics, this individual will manage cross-functional biometrics activities spanning clinical data management (CDM), statistical programming, medical coding, and clinical systems development. The ideal candidate brings hands-on technical expertise, strong operational acumen, and proven leadership in a CRO or sponsor environment operating under 21 CFR Part 11, ICH-GCP, and CDISC standards.

Key Responsibilities

Clinical Data Management

• Oversee end-to-end CDM activities including database design, data validation, edit check programming, and database lock across multiple concurrent studies

• Review and approve CDM deliverables including Data Management Plans (DMPs), Data Validation Specifications (DVS), and edit check specifications

• Ensure data quality and timely delivery against study timelines in compliance with ICH-GCP, 21 CFR Part 11, and sponsor SOPs

• Manage client-facing CDM interactions including status reporting and escalation management

Statistical Programming

• Provide operational oversight of statistical programming activities including SDTM and ADaM dataset development, TFL generation, and submission package preparation

• Collaborate closely with biostatistics to align on analysis-ready datasets and study deliverable timelines

Medical Coding

• Oversee medical coding operations using MedDRA and WHODrug dictionaries across active study portfolios

• Ensure coding quality, consistency, and dictionary version control in alignment with sponsor requirements and regulatory standards

• Manage coder training, coding conventions documentation, and query resolution workflows

Clinical Systems Management

• Lead the administration, configuration, and validation of clinical systems including Medidata Rave EDC and Medidata CTMS/Balance

• Oversee system validation activities including UAT planning, IQ/OQ/PQ execution, and associated documentation in compliance with 21 CFR Part 11

• Evaluate and implement emerging eClinical technologies and tools to improve operational efficiency and data quality

• Serve as primary operational contact for eClinical system vendors and internal IT on system-related issues

Operations & People Leadership

• Manage, mentor, and develop a team of CDM professionals, programmers, and coders across geographically distributed teams

• Define and enforce standard operating procedures (SOPs), work instructions, and quality standards across the biometrics function

• Drive capacity planning, resource allocation, and workload balancing across the project portfolio

• Support business development activities including contributing to RFP responses, client presentations, and capability discussions

• Track and report KPIs for biometrics operations to senior leadership; identify and implement process improvement initiatives

Required Qualifications

• Bachelor's degree or higher in life sciences, statistics, computer science, health informatics, or a related field

• Minimum 7 years of progressive experience in clinical data management and/or biometrics within a CRO, pharmaceutical, or biotech organization

• Hands-on expertise with Medidata Rave EDC and CTMS

• Demonstrated leadership experience managing cross-functional biometrics teams including CDM, statistical programming, and/or medical coding

• Strong working knowledge of 21 CFR Part 11, ICH-GCP, CDISC/SDTM/ADaM standards, and MedDRA/WHODrug coding

• Proven ability to manage multiple studies simultaneously in a fast-paced, deadline-driven environment

• Strong communication skills with the ability to present complex data topics to executive and sponsor audiences

Preferred Qualifications

• Experience in oncology, rare disease, and/or neurology therapeutic areas

• Familiarity with AI-assisted or automated clinical data workflows

• Experience supporting FDA or EMA regulatory submissions (NDA, BLA, IND)

• CCDM (Certified Clinical Data Manager) or equivalent professional certification

• Prior experience in a CRO environment managing sponsor-facing deliverables

• Exposure to eCOA, eConsent, or CTMS platforms beyond Medidata

Core Competencies

• Team Management and Mentorship
• Cross Functional Collaboration
• Executive Level Communication
• Client Relationship Management
• Process Improvement and SOP Development

Technical Competencies

• CDISC/SDTM/ADam proficiency
• Medidata Rave and CTMS/ Balance
• MedDRA/WHO drug coding standards
• 21 CFR part 11/ ICH GCP compliance
• System Validation ( IQ/QQ/PQ, UAT)

Why ClinFocus

• Work at the intersection of AI innovation and clinical research operations in a fast-growing, data-first CRO

• Lead a high-impact function with direct visibility to executive leadership

• Collaborate with multidisciplinary teams on complex oncology, rare disease, and neurology trials

• Fully remote position with flexibility and a results-oriented culture

• Competitive compensation, professional development support, and a mission-driven team