Philips este o companie de tehnologie medicală, cu activități care acoperă echipamentele clinice, îngrijirea conectată și sănătatea consumatorilor. Portofoliul său include sisteme de imagistică prin rezonanță magnetică și tomografie computerizată, ecografe portabile, soluții de monitorizare a pacienților și de terapie intensivă, precum și produse pentru consumatori, cum ar fi dispozitivele de igienă orală Sonicare și aplicația Pregnancy+. Philips reunește echipamente și tehnologii medicale pentru a sprijini personalul clinic și persoanele care își gestionează sănătatea. Echipele sale activează în aceste domenii, iar oportunitățile profesionale sunt legate de portofoliul de produse medicale și de consum al companiei.
Clinical Study Manager
Lead compliant clinical studies at Philips, coordinating sites, regulatory records, data quality, schedules, and budgets. Maintain audit readiness and work with cross-functional teams to meet study objectives.
Descriere
- Oversee clinical studies from setup through completion.
- Keep study activities aligned with regulatory standards and Philips procedures.
- Assess and monitor sites, train study teams, and manage close-out activities.
- Advise study sites and investigators as a subject matter expert.
- Explain protocol requirements, study procedures, and regulatory expectations to sites and investigators.
- Check project records for accuracy and regulatory compliance.
- Improve study efficiency and data quality through process changes, data review, and verification.
- Coordinate with Clinical, Medical, Biostatistics, Data Management, Regulatory, Quality, R&D, and other internal teams.
- Track study delivery against milestones, schedules, and budgets.
- Spot risks, resolve issues, and support ongoing improvement.
- Report study progress to senior management.
- Maintain audit readiness and support program objectives.
Cerințe
- At least five years of clinical research execution experience; medical device industry experience is preferred, with pharma, biotech, academic, or government research also relevant.
- Strongly preferred: knowledge of medical device clinical trial design and best practices.
- Preferred familiarity with ISO 13485, ISO 14155, and ICH/GCP guidelines.
- A bachelor's or master's degree in a related field is required.
- A doctorate or higher degree is preferred.
- Knowledge of ISO, GCP, FDA requirements, and Philips procedures.
- Proficiency with EDC, eTMF, and CTMS systems.
- Strong attention to detail.
- A willingness to learn and respond to coaching.
- Ability to meet the role's minimum physical, cognitive, and environmental requirements, with or without accommodation.
- Willingness to travel up to 10% based on business needs.
- Must live in the Pittsburgh, Pennsylvania area.
- US work authorization is required; current or future visa sponsorship is unavailable.
- Must be able to work without company relocation benefits.
Beneficii
- Annual incentive bonus.
- Sales commission.
- Long-term incentives.
- Generous paid time off.
- 401(k) with up to a 7% company match.
- Health savings account with a company contribution.
- Employee stock purchase plan.
- Education reimbursement.
- Philips Total Rewards benefits program.