Manager, Clinical & Product Operations

SiPhox Health is building a home blood testing platform for biomarkers. The Manager, Clinical & Product Operations supports clinical operations across compliance, quality, complaint handling, and new product launches, while helping develop and test clinical products and content.

Responsibilities

Keep our documentation audit-ready

Catch errors before they reach a customer

Keep launches on track across clinical, product, operations, and software

Manage HIPAA compliance and complaints handling day-to-day

Keep company assets organized and build the processes the rest of the team relies on

Support the Director in keeping clinical operations in line with HIPAA and FDA requirements

Maintain compliance documentation, records, and evidence so we are ready for audits and partner lab inspections at any time

Track business associate agreements (BAAs), vendor compliance documents, and renewal dates

Run HIPAA housekeeping: access reviews, training completion, and prompt reporting of potential incidents

Maintain training records, competency checklists, and credentialing files (license verification, renewals) for employed and contracted clinical staff

Review the processes for result monitoring, critical and abnormal value escalation, and pre-release checks; flag gaps and propose improvements to the Director

Audit the review workflows for biomarker panels, reports, automated insights, and AI-generated summaries, and make sure they are documented, followed, and working as intended

Draft and update SOPs and work instructions for approval, and keep document control tight so the approved version is always the one in use

Log deviations and track corrective and preventive actions (CAPAs) to completion

Track sample rejection and redraw reasons (hemolysis, insufficient volume, transit delay) and share patterns with product and operations

Review physical and electronic kit instructions for accuracy and keep printed and digital versions in sync

Own the complaint log, with intake from customer support, reviews, B2B partners, and labs

Triage each complaint for clinical and safety significance, and escalate potential adverse events or result errors to the Director immediately

Coordinate investigations with the lab, manufacturing, operations, and software teams, and document root cause and resolution

Report complaint trends monthly so recurring problems get fixed at the source

Coordinate the clinical workstream for new panels, kit variants, and results features, from requirements through launch

Maintain launch checklists and track clinical sign-offs, validation documentation, and regulatory review

Make sure SOPs, training, health content, and kit instructions are updated before anything goes live

After launch, monitor early results, complaints, and redraw rates and report what needs to change

Help the clinical team document requirements for new products: biomarkers, reference ranges, interpretation rules, and insight content

Build and run test cases (edge cases, borderline values, unusual combinations) for new reports and AI features before release

Prepare literature summaries to support clinical content and product decisions

Fact-check health content, route it for clinical approval, and keep the approval record

Audit a sample of coaching conversations and content against our line between health coaching and medical advice

Preferred

hands-on experience as a phlebotomist, medical assistant, lab technician, or EMT

Eager to learn: you want to grow into clinical operations, quality, regulatory, or product work, and you'll get a close view of all four

Phlebotomy

Medical Assisting

Laboratory Technology

Emergency Medical Technician (EMT)

Clinical Operations

Regulatory Affairs

Product Development

Eagerness to Learn

Benefits

Stock options, and meaningful equity in a company solving a problem that matters

Company

At-home biomarker testing and personalized health action plans.

Burlington, Massachusetts, USA

https://siphoxhealth.com/

Founded in 2020

11-50 employees

Qualifications

Bachelor's degree in a health, life science, or chemistry-related field (e.g., biology, biochemistry, chemistry, biomedical engineering, biotechnology, biomathematics, nursing, clinical laboratory science)

At least 1 year of professional experience after college in a health or product role

Comfortable reading lab results, including units, reference ranges, and what makes a value abnormal, or able to learn quickly

Highly organized: you can keep a launch checklist moving across five teams without losing track of a single sign-off

Strong documentation habits: you write things down so the next person, or the auditor, doesn't have to guess

Comfortable with spreadsheets, ticketing systems, and shared documentation tools

Rigorous attention to detail: you catch the wrong unit, the swapped range, the typo in step 4 of the instructions

Composure under pressure: to you, a spike in complaints or a slipping launch calls for a procedure, not a panic

Ownership: you follow an escalation, a complaint, or a launch task until it's closed, not just until it's handed off

Process-minded: when you see something done three different ways, you fix it once and write it down

Low ego and high standards: willing to do unglamorous work while holding the bar high

Hands-on experience as a phlebotomist, medical assistant, lab technician, or EMT

Eager to learn: you want to grow into clinical operations, quality, regulatory, or product work, and you'll get a close view of all four

Required skills

Represents the skills you have, click on the tags

Experience

1+ years