Contractor, Clinical Trial Manager

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 Role:

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.

Key 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.

Desired Experience/Education and Personal Attributes:

• 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
• Oncology trials experience is preferred
• 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.

About Syndax:
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.

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.

Originally posted on Himalayas