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.
• Led 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.
• Develops CRF designs, database structures, edit checks, and coding dictionaries (MedDRA, WHODrug) in collaboration with CRO partners.
• Conducts data reconciliation activities including SAE reconciliation, central lab data integration, and third-party vendor data transfers.
• Supports preparation for regulatory submissions by ensuring data packages meet quality standards and timelines, including CDISC (CDASH, SDTM) compliance.
• Supports the development and maintenance of SOPs, work instructions, and best practices for clinical data management.
• 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. Advanced degree preferred, or equivalent professional experience.
• Minimum 8 years of clinical data management experience in the pharmaceutical/biotech industry. Experience across multiple therapeutic areas a plus.
• Strong expertise managing data for Phase I-III clinical trials; 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.