Contractor, Clinical Trial Manager

Syndax Pharmaceuticals•New York, NY

10d•Remote

About The Position

Syndax Pharmaceuticals is looking for a Contractor, Clinical Trial Manager. At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The CTM is a key contributor to the successful execution of clinical trials, performs a key role in building and maintaining relationships with Investigators and other study site personnel, CRAs, CRO team members and all external vendors. Based on a thorough understanding of the mechanics of conducting clinical trials, the CTM will closely supervise all aspects of Clinical Trial Operations, including clinical project management, oversight of study center activities, CRA monitoring activities and vendor management and will work cross-functionally to ensure trials are delivered on time, with appropriate quality and within budget.

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.
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

Nice To Haves

Oncology trials experience is preferred

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.