Clinical Trial Manager - East Coast (MedTech)
ΠΡΡΡ & Π‘ΠΎΠΏΡΠΎΠ²ΠΎΠ΄
ΠΠ»Ρ ΠΌΡΡΡΠ° Ρ ΡΡΠΎΠΉ Π²Π°ΠΊΠ°Π½ΡΠΈΠ΅ΠΉ Π½ΡΠΆΠ΅Π½ Plus
ΠΠΏΠΈΡΠ°Π½ΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ
Location: Remote position for candidates based in Philadelphia, New York, New Jersey, Pittsburgh, Atlanta, Washington, DC, Orlando, Fairfax, or Boston. Travel required up to 25%.
Salary: $95,000β$130,000 base salary plus cash bonus.
Company
is a publicly traded medical technology company developing AI-driven, non-invasive solutions for diagnosing and managing coronary artery disease.
What you will do
- Oversee clinical operational activities at the trial and site level, including site management, documentation, vendor coordination, and project management.
- Develop clinical trial timelines, enrollment projections, instructional materials, communication plans, monitoring plans, and risk mitigation strategies.
- Lead process improvement initiatives and contribute to standard operating procedure development.
- Coordinate study start-up activities, including protocols, informed consent forms, source document worksheets, and training presentations.
- Review informed consents, IRB approvals, research agreements, and other regulatory documents for compliance with study requirements and GCPs.
- Collaborate with investigators, site research coordinators, staff, core laboratories, data management teams, and other vendors.
Requirements
- Bachelorβs degree in science or a health-related field.
- At least 5 years of relevant clinical research experience.
- Knowledge of ICH Guidelines, US FDA requirements, and European clinical trial regulations.
- Excellent written and oral English communication skills.
- Strong organizational skills, attention to detail, prioritization, and the ability to manage multiple shifting priorities.
- Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.
Nice to have
- Experience in cardiovascular medical device clinical research.
- Experience working in a smaller team with an all-hands-on-deck approach.
Culture & Benefits
- Fast-paced start-up environment with cross-functional collaboration.
- Remote work arrangement with up to 25% travel.
- Base salary supplemented by a cash bonus.
- Equal opportunity workplace committed to an inclusive and respectful environment.
ΠΡΠ΄ΡΡΠ΅ ΠΎΡΡΠΎΡΠΎΠΆΠ½Ρ: Π΅ΡΠ»ΠΈ ΡΠ°Π±ΠΎΡΠΎΠ΄Π°ΡΠ΅Π»Ρ ΠΏΡΠΎΡΠΈΡ Π²ΠΎΠΉΡΠΈ Π² ΠΈΡ ΡΠΈΡΡΠ΅ΠΌΡ, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΡ iCloud/Google, ΠΏΡΠΈΡΠ»Π°ΡΡ ΠΊΠΎΠ΄/ΠΏΠ°ΡΠΎΠ»Ρ, Π·Π°ΠΏΡΡΡΠΈΡΡ ΠΊΠΎΠ΄/ΠΠ, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡΠ΅ ΡΡΠΎΠ³ΠΎ - ΡΡΠΎ ΠΌΠΎΡΠ΅Π½Π½ΠΈΠΊΠΈ. ΠΠ±ΡΠ·Π°ΡΠ΅Π»ΡΠ½ΠΎ ΠΆΠΌΠΈΡΠ΅ "ΠΠΎΠΆΠ°Π»ΠΎΠ²Π°ΡΡΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡΠΈΡΠ΅ Π² ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΡ. ΠΠΎΠ΄ΡΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β