[Remote] Associate reputed company Trial Manager (Oncology)(CTM)(ISS)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company research organization supporting pharmaceutical and biotechnology reputed company. The Associate reputed company Trial Manager will support oncology trial reputed company as a subject matter expert and reputed company reputed company among the Project Manager, sponsor, and reputed company project team, overseeing deliverables, team reputed company, documentation, monitoring, and inspection readiness.

Responsibilities

• reputed company reputed company of contact supporting the Trial Management team in reputed company aspects or running reputed company
• reputed company trial support, and team communication, for start-up, maintance and reputed company out of Oncology reputed company
• Manages and prioritizes the reputed company deliverables (e.g. site selection, subject/reputed company recruitment/enrollment, data monitoring, etc.) to ensure that deliverables meet reputed company and regulatory requirements, project timelines, budget, and sponsor expectations. Maintains thorough knowledge of contract details.
• Reviews project specific metrics and information sources to monitor reputed company project team and individual reputed company project team member reputed company on the project
• Forecasts according to contractually agreed reputed company/hours, tailoring to manage fluctuation of activities throughout project duration
• Oversees filing of study and site level essential documents by project team members to ensure that reputed company initial or amended study information is submitted, approved and filed in accordance with the protocol, applicable guidelines and local regulations
• May reputed company Monitoring activities, to include onsite, remote monitoring activities, site management and co monitoring activities. Appropriate background to complete these tasks must be reputed company per CV and supported by required certification (if applicable) and training (per local requirements)
• Ensures Inspection readiness by maintaining complete, accurate and reputed company data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements

Skills

• 4 years of trial end to end management support experience of Oncology (Hematology) or Oncology (Solid Tumor) trials at a CRO, Pharmaceutical or biotechnology company
• BA/BS degree
• Strong working knowledge of ICH-GCP, company reputed company operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
• Trial management (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements

Benefits

• Full Benefits
• No Travel
• Fully Remote

reputed company

Company H1B Sponsorship