Note: The job is a remote job and is open to candidates in USA. Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing innovative cancer therapies. The Contractor Clinical Trial Manager oversees the day-to-day execution of clinical trials, including study team coordination, site and vendor management, regulatory compliance, timelines, budgets, and cross-functional communication.
Responsibilities
- Manage and lead the day-to-day operations 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 scope of assigned trial(s), participate in or manage and lead cross-functional study teams, including vendors; liaise with other functional areas in order to accurately coordinate clinical study activities
- Understand lab sampling practices and lab vendor oversight in cooperation with cross-functional team(s)
- Develop informed consent forms, study training materials, and study tools for assigned trial(s)
- Provide input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications
- Provide timely review, approval, and sign-off of key study documents
- Oversee the performance of CROs and third-party vendors to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Clinical Operations management
- Able to understand, interpret and explain study protocol requirements to others
- Identify risks and develop mitigation strategies in collaboration with cross functional study team
- Manage study timeline and provide study progress reports to management
- Maintain tracking for study metrics essential to managing the study closely (patient 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 healthcare discipline
- * At least 5 years of clinical trial management experience in pharmaceutical industry or CRO with progressive responsibilities within operations
- * Must have understanding of clinical trials from start-up through close-out, including experience with Inspection Readiness
- * Ability to lead effective meetings, demonstrate a good sense of judgment, and ensure cross-functional communication of important study decisions and milestones
- * Working knowledge of GCPs and FDA and ICH regulations and guidelines
- * Experience managing external service providers
- * Experience with international clinical trials including those run in EU, CA and Australia
- * Good understanding of cross functional areas including data management / biostatistics, regulatory affairs and pharmacovigilance
- * Proven verbal and written communication skills; enjoys interacting with others regularly
- * Able to prioritize tasks and work independently
- * Able to travel an average of 5-10%, both domestically and internationally
- Location**: While our corporate headquarters are located in New York City, this position is open to candidates from any location with a preference for east coast locations
- * Oncology trials experience is preferred
Benefits
- Position is open to candidates from any location, with a preference for east coast locations.
- Remote work (#LI-Remote)
Company Overview
Company H1B Sponsorship