Lead Data Manager

JOB TITLE: Lead Data Manager REPORTS TO: Manager, Data Management or Senior Manager, Data Management DIRECT REPORTS: Not Applicable POSITION SUMMARY: The Lead Data Manager is responsible for overseeing the data management processes across clinical trials, ensuring the quality, integrity, and compliance of clinical trial data. This position involves leading the protocol assigned data management team members, collaborating with cross-functional teams, and playing a pivotal role in the success of clinical studies. KEY RESPONSIBILITIES:

• Oversee the design, implementation, and maintenance of the selected EDC system or systems
• Lead the creation and review of data management documentation (e.g., CRFs, data dictionaries, data validation plans)
• Mentor any applicable data management team members, providing guidance and training as needed
• Ensure protocol assigned team members are meeting deadlines, following SOPs, and maintaining high standards for data quality
• Work closely with clinical operations, biostatistics, clinical monitoring, and regulatory teams to ensure data management activities align with study goals and timelines
• Track data management progress and provide regular updates to study teams and management

Provide feedback on draft protocols, TLFs, and Statistical Analysis Plans as needed

• Other data management services as required

REQUIRED QUALIFICATIONS:

• High school diploma or equivalent
• Strong communication skills with the ability to manage multiple projects simultaneously
• Capable of completing deadlines on time and regulate priorities in a fast-paced environment
• Knowledge of CDISC (CDASH, SDTM)
• Great organizational skills with the ability to multi-task
• Proficient in various EDC systems

PREFERRED QUALIFICATIONS: 5+ years of data management experience in the Pharmaceutical and/or CRO setting

• MedDRA and WHODrug coding experience preferred, but not required.