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About the Role

The position is responsible for the oversight, coordination, and execution of clinical data management activities across one or more clinical trials. This individual plays a key leadership role in the design, oversight, and execution of clinical data strategies that support high-quality, regulatory-compliant data deliverables. This position works on extremely complex problems and unique issues requiring conceptual thinking and independent judgment. It involves frequent collaboration with cross-functional teams and key stakeholders, requiring effective communication and the ability to guide others on complex matters. The role may lead high-impact initiatives and influence diverse stakeholders, recognized internally as a subject matter expert.

Responsibilities

Lead all Clinical Data Management tasks for a project including the development of eCRFs, eCRF completion guidelines, Data Management Plan (DMP) and other Clinical Data Management documents.
Oversee the implementation of project specific Clinical Data Management Systems and/or processes for assigned projects.
Oversee the implementation of plans for the processing of data within established timelines and budget specifications, and make necessary adjustments based upon project needs.
Lead clinical data management activities from study start-up through database lock.
Design, review, and finalize case report forms (CRFs) in collaboration with cross functional team members.
Develop and maintain data management plans, data review guidelines, and edit check specifications.
Oversee database development, validation, user acceptance testing and go live activities.
Monitor data flow, ensure timely and quality data availability for analysis.
Ensure compliance with standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements.
Review and contribute to clinical protocols and statistical analysis plans to ensure alignment with data collection objectives.
Manage and collaborate with external vendors, CROs, and partners related to outsourced data management tasks.
Represent data management in cross-functional meetings and communicate project status, risks, and resolutions.
Provide analysis and feedback on Clinical Data Management tasks, systems or processes.
Contribute to the development and improvement of data management processes and tools.
Monitor and manage study budgets to ensure financial efficiency and compliance.
Assess change orders, evaluating cost overruns to mitigate financial risk while maintaining study integrity.
Train and mentor junior team members, promoting best practices in clinical data standards and compliance.
Participate in audits and inspections, contributing to the development of corrective and preventive actions.
Communicate with all departments as necessary regarding project status/issues.
Perform other duties as assigned.

Requirements

Bachelor's degree in related scientific discipline.
Minimum of 10 years related industry experience.
Strong understanding of CDISC standards (CDASH, SDTM), ICH-GCP, FDA, and other regulatory guidelines.
Expert knowledge of Electronic Data Capture (EDC) systems (e.g., Medidata Rave, Veeva).
Experience with database design, development and user acceptance testing required.
Expert knowledge of clinical trial processes, data flow, and data cleaning best practices.
Excellent problem-solving skills with the ability to resolve complex technical issues.
Effective communication and leadership skills with the ability to influence cross-functional teams, levels, including executive leadership.
Experience working with CROs, vendors, and global clinical teams.
Proven track record leading data management for global clinical trials in a sponsor or CRO setting.
Demonstrates excellent written and verbal communication.
Strong organizational and prioritization abilities.
Exceptional critical thinking and project management skills.
Ability to handle multiple projects and work in a team environment.

Skills

CDISC standards (CDASH, SDTM)
ICH-GCP
FDA
Electronic Data Capture (EDC) systems
Medidata Rave
Veeva
Database design
Database development
User acceptance testing
Clinical trial processes
Data flow
Data cleaning
Problem-solving
Communication
Leadership
Project management

Location

New York City
Remote
East coast locations preferred

Work Type

Contractor
Full-time

Experience Level

Senior
Minimum of 10 years related industry experience

Education Level

Bachelor's degree in related scientific 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.