Contractor – Clinical Trial Manager

🕒 Yesterday

🗽 New York – Remote

🗽 New York – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Syndax Pharmaceuticals

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

Syndax Pharmaceuticals is a biotechnology company located in Waltham, Massachusetts. The company specializes in the development of innovative therapies to address unmet medical needs in cancer treatment and other serious diseases.

📋 Description

• 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

• 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

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