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About the Role

The Clinical Trial Manager (CTM) is a key contributor to the successful execution of clinical trials. This role involves building and maintaining relationships with investigators, site personnel, CRAs, CRO teams, and external vendors. The CTM will closely supervise all aspects of Clinical Trial Operations, ensuring trials are delivered on time, with appropriate quality, and within budget.

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.
• Participate in or manage and lead cross-functional study teams, including vendors; liaise with other functional areas 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.
• 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.).
• Demonstrate basic fiscal awareness (e.g., contract, budget, invoicing) and ability to review invoices against statement of work documentation.
• Support SOP development and implementation.

Requirements

• 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.
• 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.

Skills

• Oncology trials experience is preferred.
• Ability to lead effective meetings.
• Demonstrate a good sense of judgment.
• Ensure cross-functional communication of important study decisions and milestones.
• Working knowledge of GCPs and FDA and ICH regulations and guidelines.

Location

• New York City
• Remote
• East coast locations preferred

Work Type

• Contractor
• Full-time

Experience Level

• 5+ years

Education Level

• Bachelors’ Degree in life sciences or healthcare discipline

About the Company

• Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies.
• Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease.
• Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment.
• For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn.

Equal Opportunity

• Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.