Philips — жеке денсаулық сақтау, диагностика мен емдеу және байланысқан медициналық көмек салаларында инновациялар әзірлейтін жаһандық денсаулық сақтау технологиялары компаниясы. Оның қызметі адамдардың денсаулық нәтижелерін жақсартуға қолдау көрсетіп, медицина қызметкерлеріне тиімді әрі өзара байланысқан көмек ұсынуға көмектесуге бағытталған.
Clinical Study Manager, Medical Devices — Pennsylvania Remote
Lead compliant medical device clinical studies for Philips, coordinating sites, documentation, data quality, budgets, and regulatory readiness. This remote role requires local proximity to Pittsburgh, Pennsylvania.
Сипаттама
- Lead clinical studies and maintain regulatory compliance throughout their execution.
- Manage study records, negotiations, and team priorities.
- Coordinate site assessments, monitoring, training, and study closeout.
- Apply ISO, GCP, FDA, and Philips requirements to study work.
- Advise study sites and investigators as a subject matter expert.
- Clarify protocol requirements, study procedures, and regulatory expectations.
- Check project records for accuracy and compliance.
- Improve study efficiency and data quality through process improvements, data review, and verification.
- Work with EDC, eTMF, CTMS, and other clinical trial technologies.
- Coordinate with Clinical, Medical, Biostatistics, Data Management, Regulatory, Quality, R&D, and other internal teams.
- Track study milestones, schedules, and budgets.
- Identify risks, resolve issues, and advance ongoing improvements.
- Report progress to senior management and maintain audit readiness.
Талаптар
- At least five years of clinical research execution experience in medical devices, pharmaceuticals, biotechnology, academia, or government research is required.
- Knowledge of medical device clinical trial design and best practices is strongly preferred.
- Familiarity with relevant medical device standards, including ISO 13485, ISO 14155, and ICH/GCP guidelines, is preferred.
- A bachelor's or master's degree is required.
- A doctorate or higher degree in a related field is preferred.
- Ability to meet the role's physical, cognitive, and environmental requirements, with or without accommodation.
- Strong attention to detail.
- A learning mindset and openness to coaching.
- Travel of up to 10% may be required based on business needs.
- Must live in the Pittsburgh, Pennsylvania area to be near study sites.
- US work authorization is required.
- Must not need sponsorship for a work-authorized visa now or in the future.
Артықшылықтар
- An annual incentive bonus may be available.
- A sales commission may be available.
- Long-term incentives may be available.
- Paid time off.
- 401(k) plan with up to a 7% company match.
- Health savings account with a company contribution.
- Employee stock purchase plan.
- Education reimbursement.
- Relocation benefits are not provided.