Top 3952 Advanced Microsoft Database Organization Jobs

Senior Clinical Affairs Specialist
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ChenMed —East Point, GA
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University of Saint Mary of the Lake —Mundelein, IL
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Manager, OSP Engineering (MDU)
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ChenMed —Detroit, MI
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Primary Care Physician - Miami Dade County Various Locations
ChenMed —Miami, FL
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Senior Accountant
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- Full-time
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Lead Teacher - Education Center Director
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Post Market Surveillance Engineer II
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- Full-time
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- Mid-level
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Senior Clinical Affairs Specialist

Confidential
Houston, TX

Quick Apply

Job Details

Full-time
$110,000 - $125,000 a year
12 days ago

Benefits

Stock options
Relocation assistance
Health insurance
Dental insurance
Paid time off
Vision insurance

Qualifications

Data integrity assurance
FDA submissions
Data quality checks
Google Workspace
Operations coordination
Project timeline management
Data integrity and documentation
Schedule management
ICH guidelines
Data quality monitoring
Clinical program monitoring
Managing clinical research teams
Regulatory submission editing and review
Biomedical regulatory compliance
Communication with regulatory authorities for clinical trials
Neurology
Productivity software
Clinical quality assurance standards
Data collection
IRB compliance
Research budget management
Ethical review application preparation
ISO 13485
Operational budget management

Full Job Description

About

The Company is an innovative medical device organization focused on advancing neurostimulation technologies. We are dedicated to pioneering new standards of care for mental health. With our lead medical device advancing into pivotal clinical development, we are seeking an experienced Senior Clinical Affairs Specialist to drive the day-to-day execution of clinical studies and support the generation of clinical evidence necessary for regulatory and commercial objectives.

The Role

The Senior Clinical Affairs Specialist will be the operational owner of our pivotal and post-market clinical programs. This role Reports to the CEO and works closely with the executive team daily. This position is hands-on with study execution, CRO oversight, site management, and clinical data quality, and partners closely with external consultants to ensure clinical results are translated into approvable regulatory packages. Senior Clinical Affairs Specialist candidates should bring deep hands-on trial execution expertise.

Key Responsibilities

Clinical Study Execution: Drive execution of the program and future indication studies, including protocol authorship support, endpoint operationalization, and publication support
Pivotal Trial Operations: Own hands-on operational delivery of pivotal studies, including site activation, investigator engagement, IRB/EC submissions, monitoring oversight, and data quality
CRO & Site Management: Serve as the day-to-day point of contact for CRO partners, investigators, and clinical sites, ensuring trials are executed on time, within budget, and in full GCP compliance
Regulatory Submission Support: Author and contribute clinical sections of FDA De Novo, follow-on 510(k), and CE Mark (MDR) submissions; ensure all clinical data is “submission-ready”
Health Authority Support: Prepare clinical content for FDA Pre-Submissions, EMA scientific advice, and Notified Body interactions; participate in meetings as a clinical subject matter expert
Post-Market Clinical Follow-Up: Support PMCF study execution and real-world evidence collection in coordination with quality and regulatory functions

Required Qualifications

Education: Bachelor’s degree in a clinical, scientific, or engineering discipline required; Advanced degree preferred
Experience: 5–10 years of clinical research / clinical affairs experience in the medical device industry, with progressive responsibility running studies end-to-end
Clinical Domain Expertise: Direct experience executing pivotal IDE / IDE-exempt studies for Class II/III medical devices, ideally in neurostimulation, neuromodulation, neurology, or psychiatry indications
Trial Execution: Hands-on experience overseeing CROs and clinical sites for multi-site trials, including budget tracking, timeline management, and data integrity
Submissions Experience: Contribution to clinical sections of US (510(k) / De Novo / PMA) and/or European (MDR) submissions through to clearance or approval
Technical Knowledge: Working knowledge of GCP and Clinical Regulation (ISO 14155, ICH E6(R3) GCP, and 21 CFRs 50, 56, and 812); familiarity with QMSR and EU MDR is a plus (21 CFR 820 and EN ISO 13485)
Proficiency in Microsoft Office and Google Workspace

Preferred Skills

Deep hands-on monitoring, study start-up, and CRA / clinical operations experience
Background in neuroimaging (EEG, qEEG, fMRI) and digital biomarkers as clinical evidence
Experience with decentralized / “virtual clinic” trial models and digital health integration; strong written communication for presenting clinical data to internal stakeholders, investigators and KOLs

Compensation & Benefits

Base Salary (USD, annual)

Senior Clinical Affairs Specialist: $110,000 - $125,000. Houston, TX based

Annual Cash Bonus

Target 10% of annual base salary, tied to clinical trial milestones (enrollment, database lock, submission readiness) and overall company performance

Equity

Initial stock option grant valued at approximately $15,000–$50,000 (vesting over 3 years) plus eligibility for annual refresh grants

Benefits

Medical, dental, and vision insurance; paid time off; employee stock incentive plan (if applicable); and professional development support.

Pay: $110,000.00 - $125,000.00 per year

Benefits:

Dental insurance
Health insurance
Paid time off
Relocation assistance
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

Advanced Microsoft Database Organization jobs

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