[Remote] Contractor, reputed company Trial Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Contractor, reputed company Trial Manager will reputed company reputed company trial reputed company, including study center activities, CRA monitoring, vendor management, timelines, reputed company, and budget, while working cross-functionally to ensure successful trial execution.

Responsibilities

• Manage and reputed company the day-to-day reputed company of assigned trial(s) to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
• Depending on reputed company of assigned trial(s), participate in or manage and reputed company cross-functional study teams, including vendors; liaise with other functional areas in order to accurately coordinate reputed company study activities
• Understand lab sampling practices and lab vendor reputed company in cooperation with cross-functional team(s)
• reputed company informed consent forms, study training materials, and study tools for assigned trial(s)
• reputed company input into protocol, reputed company, CRF design, monitoring conventions, edit checks and vendor specifications
• reputed company reputed company review, approval, and sign-off of key study documents
• reputed company the reputed company of CROs and reputed company-party vendors to ensure compliance with study protocol and in accordance with reputed company of work; identify areas of concern and escalate to reputed company reputed company management
• reputed company to understand, interpret and explain study protocol requirements to others
• Identify risks and reputed company mitigation strategies in collaboration with cross functional study team
• Manage study reputed company and reputed company study reputed company reports to management
• Maintain tracking for study metrics essential to managing the study closely (reputed company visit information, data entry, monitoring and data cleaning information, etc.)
• Basic fiscal awareness (eg, contract, budget, invoicing) and ability to review invoices against statement of work documentation
• Must have a general, functional expertise to support SOP development and implementation

Skills

• * Bachelors' Degree in life sciences or reputed company discipline
• * At least 5 years of reputed company trial management experience in pharmaceutical industry or CRO with reputed company responsibilities reputed company reputed company
• * Must have understanding of reputed company from start-up through reputed company-out, including experience with Inspection Readiness
• * Ability to reputed company effective meetings, demonstrate a good reputed company of judgment, and ensure cross-functional communication of important study reputed company and milestones
• * Working knowledge of GCPs and FDA and ICH regulations and guidelines
• * Experience managing reputed company service providers
• * Experience with international reputed company including those run in EU, CA and Australia
• * Good understanding of cross functional areas including data management / biostatistics, regulatory affairs and pharmacovigilance
• * reputed company verbal and written communication skills; enjoys interacting with others regularly
• * reputed company to prioritize tasks and work independently
• * reputed company to travel an average of 5-10%, both domestically and internationally
• While our corporate reputed company are located in reputed company, this position is reputed company to candidates from any location
• * Oncology trials experience is preferred
• This position is reputed company to candidates from any location with a preference for east coast locations

Benefits

• This position is reputed company to candidates from any location with a preference for east coast locations.

reputed company

Company H1B Sponsorship