Note: The job is a remote job and is open to candidates in USA. Clinovo is seeking a Senior Clinical Data Manager to lead clinical data management activities across one or more clinical trials. The role oversees data strategy, systems, documentation, vendor collaboration, regulatory compliance, study budgets, and database activities from study start-up through database lock, while serving as a subject matter expert and mentoring junior team members.
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
- Recent Sponsor experience is a MUST
- Only W-2 or 1099
- NO C2C
- • Bachelor's degree in a related scientific discipline
- • Minimum of 10 years of 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 and 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
Company Overview
Company H1B Sponsorship