Contractor - Senior Clinical Data Manager
About The Position
The position is responsible for the oversight, coordination, and execution of clinical data management activities across one or more clinical trials. This position applies broad expertise across specialized fields within clinical data management and related disciplines. 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 in which analysis of situations or data requires intangible variables. Requires conceptual thinking to understand advanced issues and implications. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. The position involves frequent collaboration with cross-functional teams and key stakeholders beyond the immediate domain of clinical data management. Effective communication, persuasive influence, and the ability to guide others on complex matters are essential. May lead high-impact initiatives and must have the ability to influence and align diverse stakeholders across the organization. Recognized internally as a subject matter expert.
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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
