Contractor – Clinical Trial Manager

Syndax Pharmaceuticals

. Manage and lead day-to-day operations of assigned clinical trials in compliance with GCP/ICH guidelines and regulatory requirements .

Posted 11/3/2026contractRemote • New York • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical trials in compliance with GCP/ICH guidelines, with a strong focus on oncology trials and cross-functional team leadership. Proficient in protocol development, risk management, and vendor oversight, ensuring effective communication and operational efficiency.

Highest-signal resume keywords

Clinical Trial ManagementGCP/ICH ComplianceOncology Trials ExperienceCross-Functional Team LeadershipRisk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementProtocol DevelopmentData ManagementBiostatisticsRegulatory AffairsPharmacovigilanceInspection ReadinessStudy Metrics TrackingVendor ManagementSOP Development

Soft Skills

Verbal CommunicationWritten CommunicationTask PrioritizationIndependent WorkMeeting Leadership

Industry Keywords

Clinical TrialsPharmaceutical IndustryCROInternational Clinical TrialsFDA RegulationsEU RegulationsCA RegulationsAustralia RegulationsInformed Consent FormsStudy Training Materials

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Manage and lead day-to-day operations of assigned clinical trials in compliance with GCP/ICH guidelines and regulatory requirements
Participate in or manage and lead cross-functional study teams, including vendors
Coordinate clinical study activities with other functional areas
Oversee lab sampling practices and lab vendors
Develop informed consent forms, study training materials and study tools
Provide input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications
Review, approve and sign off on key study documents
Oversee CRO and third-party vendor performance and escalate concerns
Interpret and explain study protocol requirements
Identify risks and develop mitigation strategies
Manage study timelines and provide progress reports to management
Track study metrics including patient visits, data entry, monitoring and data cleaning
Review invoices against statements of work
Support SOP development and implementation

Requirements

What you’ll need

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
Understanding of clinical trials from start-up through close-out, including experience with Inspection Readiness
Oncology trials experience is preferred
Ability to lead effective meetings 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 data management, biostatistics, regulatory affairs and pharmacovigilance
Proven verbal and written communication skills
Ability to prioritize tasks and work independently
Ability to travel an average of 5–10%, domestically and internationally