Clinical Program Manager

SiPhox Health; Burlington (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

SiPhox Health is seeking a Clinical Program Manager to own the operational execution of clinical studies for our diagnostic products. You will collaborate with Quality, Regulatory, Assay Development, Engineering, Software, and external sites to translate study protocols into well-run programs and submission-ready data.

In this hands-on role, you will manage site startup through study closeout, coordinate sample handling, device logistics, and data reconciliation, and ensure compliance with

Qualifications

• Bachelor's degree in life sciences or similar field.
• 5+ years managing clinical studies in regulated settings.
• Experience coordinating multi-site clinical studies.
• Strong understanding of study operations, documentation, and data integrity.
• Experience working with investigators, coordinators, labs, and vendors.
• Excellent project management and organizational skills.

Responsibilities

• Manage clinical studies from protocol finalization through closeout.
• Translate protocols into operational plans, timelines, and site procedures.
• Coordinate startup activities across internal teams and external sites.
• Maintain the master study schedule and monitor enrollment and data quality.
• Ensure activities comply with protocols, SOPs, and regulatory requirements.
• Coordinate site initiation, training, and ongoing monitoring.

Skills

Project management

Organizational skills

Communication skills

Stakeholder management

Multi-site coordination

Data integrity

Education

Bachelor's degree in life sciences, biomedical engineering, clinical research, nursing, or related field

Job description

SiPhox Health is building a new generation of diagnostic systems that bring high-quality biomarker testing closer to the patient. Our platform combines silicon photonics, immunoassays, automation, software, and advanced manufacturing to enable fast, quantitative blood testing outside of the traditional central laboratory.

We are preparing our first at-home diagnostic system for FDA submission and are expanding the clinical and regulatory infrastructure needed to support multiple future assay panels.

The Role

We are looking for a Clinical Program Manager to own the operational execution of clinical studies supporting SiPhox diagnostic products.

This person will work closely with Quality, Regulatory, Assay Development, Engineering, Software, and external clinical sites to translate study protocols into well-executed clinical programs that generate high-quality, submission-ready data.

The Clinical Program Manager will be the primary operational owner of clinical studies from site startup through study closeout. This is a hands-on role suited for someone who is comfortable working in a fast-moving medical device/diagnostics environment and solving practical problems across sites, samples, devices, data, and regulatory requirements.

The role reports to the CTO office.

Responsibilities

Clinical Study Planning and Execution

• Manage clinical studies from protocol finalization through study completion and closeout.
• Translate clinical protocols into detailed operational plans, timelines, responsibilities, and site procedures.
• Coordinate study startup activities across internal teams and external sites.
• Maintain the master clinical study schedule and identify risks to enrollment, execution, data quality, and study completion.
• Ensure clinical activities are executed according to approved protocols, applicable SOPs, and regulatory requirements.
• Coordinate clinical study activities across multiple sites simultaneously.

Clinical Site Management

• Support identification, evaluation, selection, and onboarding of clinical study sites.
• Serve as the primary operational point of contact for investigators, coordinators, and other site personnel.
• Coordinate site initiation and training on study procedures, investigational devices, specimen collection, and data entry.
• Track site enrollment, study progress, open issues, and protocol compliance.
• Coordinate monitoring activities and ensure findings are resolved promptly.
• Manage site closeout and reconciliation activities.

Study Logistics

• Coordinate shipment and accountability of investigational devices, cartridges, collection materials, and study supplies.
• Manage specimen collection, labeling, handling, storage, shipping, and reconciliation workflows.
• Coordinate reference or comparator laboratory testing when required.
• Ensure study sites have appropriate inventory and materials throughout the study.
• Work closely with Manufacturing and Quality to ensure appropriate product lots and devices are available for clinical studies.

Clinical Data and Documentation

• Ensure clinical data are complete, accurate, traceable, and ready for regulatory analysis.
• Coordinate data reconciliation between clinical sites, device outputs, laboratory results, and study databases.
• Track and resolve missing data, discrepancies, and data queries.
• Maintain Trial Master File / study documentation as applicable.
• Maintain study records including training documentation, device accountability, deviations, monitoring reports, and site communications.
• Support preparation and review of clinical study reports and submission documentation.

Protocol Deviations and Study Quality

• Identify, document, investigate, and track protocol deviations.
• Work with Quality and Regulatory to assess the impact of deviations on study validity.
• Implement corrective actions when operational issues are identified.
• Identify recurring site or workflow problems and improve study procedures accordingly.
• Maintain clear documentation of clinical risks, decisions, and mitigations.

Cross-Functional Leadership

• Work closely with Regulatory Affairs to ensure clinical execution supports FDA submission requirements.
• Partner with Assay Development and Engineering to understand device behavior and appropriately manage technical issues arising during studies.
• Coordinate with Software teams on study software, data capture, device logs, and data transfer.
• Work with Quality on clinical procedures, training, deviations, CAPAs, and document control.
• Communicate study status, risks, and key decisions clearly to company leadership.

Qualifications

Required

• Bachelor's degree in life sciences, biomedical engineering, clinical research, nursing, or a related field.
• 5+ years of experience managing clinical studies in medical devices, diagnostics, biotechnology, or a related regulated industry.
• Demonstrated experience managing multi-site clinical studies.
• Strong understanding of clinical study operations, documentation, and data integrity.
• Experience working with clinical investigators, coordinators, laboratories, and external vendors.
• Excellent project management and organizational skills.
• Ability to independently drive complex programs involving multiple internal and external stakeholders.
• Strong written and verbal communication skills.
• Comfortable operating in a fast-paced environment where processes are still being built and improved.

Preferred

• Experience with IVD or diagnostic medical device clinical studies.
• Experience supporting FDA 510(k), De Novo, or PMA submissions.
• Familiarity with FDA requirements for clinical investigations of medical devices and diagnostics.
• Familiarity with GCP and applicable requirements such as 21 CFR Parts 11, 50, 54, 56, and 812.
• Experience with CLIA laboratories and comparator/reference laboratory testing.
• Experience with home-use or point-of-care diagnostic products.
• Experience managing studies involving blood collection, specimen handling, or laboratory biomarkers.
• Familiarity with usability/human factors studies is a plus.
• Experience working at an early-stage or rapidly growing medical technology company is strongly preferred.

What Success Looks Like

Within the first 6-12 months, the Clinical Program Manager should be able to:

• Independently manage SiPhox clinical studies across multiple sites.
• Keep sites, internal teams, study materials, and clinical data synchronized.
• Identify potential operational problems before they affect study timelines or data quality.
• Maintain inspection- and submission-ready clinical documentation.
• Establish repeatable clinical operations processes that can support additional assays and future regulatory submissions.
• Become the internal owner that leadership can rely on to answer: "Is the clinical study on track, and is the resulting data going to be usable?"

Ideal Candidate

The ideal candidate combines the rigor of a clinical research organization with the speed and ownership mindset of a startup.

They are comfortable moving between high-level study planning and highly practical details such as whether a site has the correct cartridge lot, why a sample was not shipped, whether a protocol deviation affects the analysis population, or whether a dataset is ready to lock.

They do not simply coordinate meetings - they take ownership of getting the clinical program completed correctly and on time.