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Affera, Inc.: Senior Clinical Data Manager

Affera, Inc.

This is a Contract position in San Jose, CA posted May 9, 2022.

About Affera Affera, Inc.

is a venture-backed medical device company dedicated to developing unrivaled solutions for the treatment of cardiac arrhythmia, a prevalent condition affecting millions of patients worldwide.

We are developing a comprehensive, integrated platform that includes RF/PF ablation and mapping catheters, a mapping system, and an ablation system.

Founded by leaders in the medical device industry, we are a highly selective team whose aim is to have a major impact on developing breakthrough, life-saving technologies.Position Overview Affera is looking for a passionate, experienced, and self-starter Senior Clinical Data Manager with strong data management skills to join our rapidly growing clinical team.

In this role, you will be responsible for the data and financial data and analysis associated with out US and EU-based trials.

This is an exciting opportunity to join at an early stage, work across multiple functions in a highly collaborative environment, and expand your set of experiences and broaden your impact.

The successful candidate for this position will be self-managing, have a high sense of urgency, and is driven to achieve technical, quality, and delivery goals.Key ResponsibilitiesDesign, program, and validate clinical electronic data capture (EDC) system(s) including user requirements, range checks, skip logic, and query logicReview EDC data and external data (i.E.

core lab data) for completeness and correctnessQuery sites/core labs for data inconsistencies, issues, or trends and escalate with Clinical Management Team as necessaryManage CRO data monitoring activities including Clinical monitoring strategy; monitoring visit scheduling, troubleshoot site and team issues, manage following up and closing issues/action items found during monitoring, and review monitoring reportsEnsure clinical data within EDC is in quality to lock/unlock as appropriate for statistical review, interim review, and/or final database lockDevelop clinical trial reports for real time tracking, vendors, and reporting requirementsDevelop study-specific documents such as Case Report Forms (CRFs), Study Worksheets, Monitoring Guidelines, External Service Provider Oversight Plan, Filing and Archiving PlanReview and track clinical related invoices and spend from sites and assigned vendorsEnsure that clinical trials are reported in accordance with the SOPs and federal regulationsEnsure real‐time inspection readiness of all assigned deliverables for the trials; participate in Regulatory Agency inspection and Affera’s internal audits as necessaryCreate trial-specific training materials and requirements for the site/CRO staff and delivering training as neededWork with biostatistics to develop reports and listings for centralized review of data; review data and spot trends to ensure quality of data.

QualificationsExperience in the Electrophysiology/AF ablation space A minimum of a BS degree or equivalent is requiredExperience reviewing, analyzing, and programming EDC systemsA minimum of 5 years of experience in managing data monitoring operations and reviewing monitoring reportsExcellent verbal and written communication and interpersonal skillsA minimum of 5 years of experience in data management (specifically in clinical data review), or significant experience with clinical data reviewDetail orientated with strong analytical skillsExperience with management and supervision of CROs/vendors is preferredPerksContribute to an innovative solution that can improve the lives of millionsBright, motivated co-workers in a fun and collaborative office environmentCompetitive pay, 401k, medical coverage