Sr. Principal, Clinical Data Lead

Role Summary

The Senior Principal, Clinical Data Lead provides leadership and expertise in all aspects of Clinical Data Management for assigned clinical trials. They are accountable for all Clinical Data Management activities throughout the clinical study lifecycle and serve as an operational lead for data management deliverables.

Responsibilities

• Primary point of contact for the execution of Data Management deliverables on assigned trials and programs, ensuring use of global program standards, coordinating study team members, and monitoring overall study progress.
• Accountable for all Data Management activities throughout the study lifecycle, including document creation, data cleaning, and query management.
• Ensure Data Management standards across assigned trials and programs, with high utilization of CRF and edit check standards library components.
• Develop and execute plans for risk identification and mitigation.
• Assess operational metrics to optimize process efficiency and communicate data topics across internal and external teams, escalating issues for timely resolution.
• Oversee issue investigation and propose solutions using experience, judgment, and precedent.
• Contribute to the development of Data Management processes, including new process creation and process improvement.
• Manage quality and efficiency with vendors (including Data Management FSP team members and external data providers) and implement improvement strategies as needed.
• Lead and participate in cross-functional collaborations, including study-level activities and special projects or initiatives.

Qualifications

• Required: Bachelor’s degree, preferably in a scientific discipline (Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.).
• Required: 7+ years of relevant work experience focused on Clinical Data Management; 4+ years as a Lead Data Manager with full accountability across study start-up, conduct, and lock.
• Required: Robust technical experience with Electronic Data Capture platforms (Medidata Rave preferred) and data review tools (Elluminate preferred).
• Required: Strong project management skills to effectively lead and collaborate with various business functions.
• Required: Excellent written and oral communication skills in English; ability to communicate with cross-functional teams in diverse scenarios.
• Required: High attention to detail with proven ability to manage multiple competing priorities.
• Required: Deep understanding of drug development and the biopharmaceutical industry.

Skills

• Clinical Data Management expertise and study execution
• Electronic Data Capture (Medidata Rave) and data review tooling
• Project management and cross-functional collaboration
• Effective written and verbal communication
• Attention to detail and prioritization under multiple deadlines
• Understanding of drug development processes and biopharma landscape

Education

• Bachelor’s degree, preferably in a scientific discipline (Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.).