Clinical Data Management Lead (Contract)

Key Responsibilities

• Execute day-to-day clinical data management activities for assigned clinical studies, including database design, edit check development, data review, and database lock.
• Contributes to the development and maintenance of study-specific data management plans, CRF completion guidelines, data validation specifications, and data transfer agreements.
• Leads and proactively manages CRO data management activities, ensuring deliverables meet quality standards, timelines, and contractual obligations while identifying risks and driving resolution.
• Serves as the data management contact for cross-functional study teams, fostering strong collaboration and proactive communication between clinical operations, biostatistics, medical monitoring, regulatory affairs, CROs, and external vendors.
• Ensures compliance with FDA, ICH-GCP, and other applicable regulatory requirements across all data management activities.
• Develop CRF designs, database structures, edit checks, and coding dictionaries (MedDRA, WHODrug) in collaboration with CRO partners.
• Supports audit and inspection readiness activities related to clinical data management, including TMF documentation.
• Identifies process improvement opportunities and contributes practical, solutions-oriented recommendations that enhance data management efficiency, quality, and study execution.
• Independently manages assigned study activities while proactively escalating risks, maintaining organizational awareness, and supporting timely decision-making and issue resolution.
• Provides data management input into study protocols, statistical analysis plans, and clinical study reports.

Experience & Skills

• Bachelor's degree in life sciences, health informatics, computer science, or a related field.
• Minimum 8 years of clinical data management experience in the pharmaceutical/biotech industry.
• Advanced degree preferred, or equivalent professional experience.
• Strong expertise managing data for Phase I-III clinical trials; experience across multiple therapeutic areas a plus.
• Solid knowledge of GCP, 21 CFR Part 11, and global regulatory requirements.
• Experience supporting regulatory filings (e.g., IND, CTA, NDA, BLA) and global clinical trials desired.
• Experience working with or overseeing CROs performing data management activities is required.
• Demonstrated ability to work effectively in a collaborative and evolving biotech environment with strong organizational, communication, and relationship-management skills.
• Working knowledge of drug development processes from pre-IND through regulatory filing.
• Strong understanding of clinical trial protocols and data flow processes.
• Demonstrated problem-solving ability with strong organizational skills and attention to detail.
• Excellent written and verbal communication skills with the ability to build collaborative working relationships across functions and external partners are required.
• Self-motivated, adaptable, and willing to contribute in a hands-on manner within a growing and fast-paced organization.

Work Environment

• Primarily desk-based, generally in an office or home office setting.
• May involve extended periods of sitting and computer use.
• Ability to stand for extended hours.
• Ability to climb ladders/steps.