Clinical Affairs Manager (Part-Time)

3 weeks, 2 days ago
Part-time
Senior
Project and Program Management
Aegis Ventures

Aegis Ventures

Aegis Ventures operates as a next generation venture studio that collaborates with entrepreneurs and industry leaders to create, launch, and expand innovative companies aimed at addressing significant societal challenges.

Professional Services
51-250
Founded 2020

Description

  • Lead clinical study design and execution across multiple hospital sites.
  • Manage relationships with clinical investigators and hospital administrators.
  • Support the FDA regulatory pathway, including Q-sub preparation and clinical trial protocols.
  • Oversee clinical data collection and analysis for regulatory submissions.
  • Establish and maintain relationships with OB/GYN departments and labor and delivery units.
  • Guide clinical workflow integration and user experience optimization.
  • Support hospital IRB processes and vendor vetting procedures.
  • Lead clinical training and education programs to support adoption.
  • Work closely with engineering, regulatory, algorithm, and business development teams on clinical requirements, validation, submissions, and partnership negotiations.

Requirements

  • Advanced degree such as MSN, MD, or PhD.
  • 5-10 years of relevant experience.
  • Direct experience in obstetrics, neonatal care, or women's health preferred.
  • Understanding of fetal monitoring technologies and labor and delivery workflows preferred.
  • Experience with clinical research, preferably medical device studies.
  • Knowledge of FDA medical device regulations, including 510(k) and PMA pathways.
  • Experience with clinical trial design, IRB processes, and GCP compliance.
  • Track record of successful regulatory submissions or clinical study management.
  • Understanding of biostatistics and clinical data analysis.
  • Medical device or healthcare technology background strongly preferred.
  • Experience working with hospital systems and clinical decision-makers.
  • Understanding of healthcare reimbursement and adoption challenges.
  • Familiarity with quality systems and ISO 13485 requirements.
  • Remote within the U.S. with approximately 25 hours per month and periodic travel to clinical sites; preference for candidates in major metropolitan areas with access to academic medical centers.

Benefits

  • Remote-first culture with periodic team gatherings.
  • Healthcare benefits and competitive compensation.
  • Equity participation in breakthrough medical technology.
  • Opportunity to directly impact maternal and neonatal outcomes globally.
  • Collaboration with world-class clinical researchers at Yale, USC, and international partners.
  • Hourly compensation of $135-$175 depending on experience and role alignment.

Interested in this position?

Apply directly on the company website

Apply Now

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