Senior Manager Biometrics Operation

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