Note: The job is a remote job and is open to candidates in USA. Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing innovative cancer therapies. The Contractor - Senior Clinical Data Manager will oversee, coordinate, and execute clinical data management activities across clinical trials, leading data strategies and ensuring high-quality, regulatory-compliant deliverables. The role also involves cross-functional collaboration, vendor management, budget oversight, mentoring, and support for study activities from start-up through database lock.
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 in collaboration with applicable service providers and/or internal teams
- 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 in collaboration with applicable service providers and/or internal teams
- 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 to ensure timely and quality data deliverables
- Represent data management in cross-functional meetings and communicate project status, risks, and resolutions
- Provide analysis and feedback (questions, issues and possible resolutions) to the line manager and/or project team 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
Skills
- 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
- 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
Company Overview
Company H1B Sponsorship