Senior Manager, Clinical Data Management

Role Summary

The Senior Manager, Clinical Data Management is responsible for all clinical data management activities and deliverables for assigned studies in accordance with ICH/GCP, GDCMP and other regulations. This role oversees vendor services, manages budgets and contracts, and serves as the subject matter expert to guide data management deliverables and timelines from study start-up through close-out, reporting, and data archiving. The position will help develop SOPs, data standards, and standardization, and drive DM operation excellence while partnering with internal teams and external vendors to ensure timely, high-quality data deliverables.

Responsibilities

• Manage assigned study/studies and provide expert recommendations to ensure timelines, deliverables, and data quality.
• Collaborate cross-functionally to resolve clinical data issues and maintain effective communication throughout drug development.
• Resolve or escalate issues at the study level to ensure DM performance.
• Provide CRO/vendor oversight to ensure requirements are met and project plans are executed.
• Leverage DM expertise to promote best practices across the drug development lifecycle and enhance stakeholder collaboration.
• Contribute to team building and best practices to achieve data quality with cost efficiency.
• Participate in regulatory audits and company initiatives.

Qualifications

• Required: MS/BS in life sciences or related field
• 7+ years of direct data management experience; at least 3 years of CRO oversight experience
• In-depth knowledge of clinical data management in Biotech/Pharmaceutical/CRO industry
• Strong project management skills with experience working with CROs/vendors
• Demonstrated organizational and interpersonal skills
• Detail-oriented with excellent communication skills in cross-functional settings
• Knowledgeable in CDISC standards, SDTM, and CFR-Part 11 compliance
• Knowledge of GCP, ICH and regional regulations
• Experience with the clinical data lifecycle from database setup to lock and archiving
• Working knowledge of current technologies in clinical trial data collection systems

Preferred

• Knowledge of current data collection technologies and integration (EDC, eCOA, CTMS, Drug Safety Database Systems, IRT)
• Proficiency in Excel and/or SAS programming

Education

• MS/BS in life sciences or related field

Travel

• You may be required to travel up to 5% of your time.