Philips este o companie globală de tehnologie medicală care dezvoltă inovații în domeniile sănătății personale, diagnosticării și tratamentului, precum și al îngrijirii conectate. Activitatea sa este concepută pentru a sprijini obținerea unor rezultate mai bune pentru sănătatea oamenilor și pentru a ajuta furnizorii de servicii medicale să ofere îngrijire eficientă și conectată.
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.
Descriere
- 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.
Cerințe
- 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.
Beneficii
- 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.