4 ΡΠ°ΡΠ° Π½Π°Π·Π°Π΄
Clinical Trial Manager
ΠΡΡΡ & Π‘ΠΎΠΏΡΠΎΠ²ΠΎΠ΄
ΠΠ»Ρ ΠΌΡΡΡΠ° Ρ ΡΡΠΎΠΉ Π²Π°ΠΊΠ°Π½ΡΠΈΠ΅ΠΉ Π½ΡΠΆΠ΅Π½ Plus
ΠΠΏΠΈΡΠ°Π½ΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ
Π’Π΅ΠΊΡΡ:
TL;DR
Clinical Trial Manager (Clinical Research): Overseeing and managing clinical operational activities at the trial and site level, coordinating cross-functional teams, vendors, and CROs with an accent on clinical trial execution, regulatory compliance, and budget control. Focus on developing monitoring plans, managing investigative sites and study deliverables, tracking risks, and ensuring compliance with GCP/ICH requirements.
Location: Hampton, NJ, United States
Company
provides scalable workforce solutions to customers across multiple industries in the United States and Canada.
What you will do
- Oversee and coordinate clinical trial operations at the study and investigative-site level.
- Lead cross-functional clinical teams and manage relationships with sponsors, vendors, and CROs.
- Develop trial timelines, enrollment projections, monitoring plans, training materials, and risk-mitigation plans.
- Coordinate investigative-site qualification and selection, investigator meetings, site training, and CRA activities.
- Manage study deliverables, vendor and CRO performance, clinical trial budgets, and cost estimates.
- Ensure study execution complies with GCP, ICH, FDA, and other applicable regulatory requirements.
Requirements
- Bachelorβs degree required; a BSN/RN or science-related degree is preferred. Candidates with relevant experience and a BA or AS may also be considered.
- At least 5 years of directly related experience, with clinical research experience strongly preferred.
- Experience in monitoring, study coordination, data management, or clinical project management, including vendor or CRO management.
- Knowledge of cGCP, ICH, and FDA regulatory requirements.
- Strong project management, analytical, problem-solving, interpersonal, oral, and written communication skills.
- Proficiency with Microsoft Office, including Word, Excel, Project, PowerPoint, and Outlook.
Nice to have
- Experience with late-stage opioid analgesics trials.
- Phase 2β3 clinical trial experience.
- Osteoarthritis clinical trial experience.
Culture & Benefits
- Six-month contract with a possible extension.
- Travel as needed to resolve field issues, provide training, and meet with partners and CROs.
- Work involves collaboration with multidisciplinary drug development and quality assurance professionals.
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