Lead Clinical Data Manager

The Clinical Data Manager II performs clinical database setup, maintenance, and data quality control functions through database lock in accordance with GCP and ICH guidelines This position can either be In-Office or work from home with less than 20% travel.

Responsibilities

• Manages processes to ensure data integrity via appropriate data management processes, such as manual data listing reviews, query review and generation for missing or discrepant data, evaluating data outliers, performing data or query quality checks, ensuring database updates are applied, etc.) in accordance with approved study documentation
• Manages project resources according to budget and notifies project manager and supervisor of any potential out-of-scope requests from clients
• Proactively performs data management study startup activities including CRF/eCRF design, CRF annotation, developing database specifications, and defining validation specifications, and database and validation specification testing
• Ensures approved study documentation is maintained and properly stored in the trial master files
• Functions as the primary contact for sites or other study team members if there are questions regarding data management issues for their assigned trial
• Participates in internal/sponsor meetings and training programs, as required, working directly with the assigned project manager to provide data management support
• May lead such meetings and provide formal training as required
• Performs and is accountable for all data management activities such as data collection and entry, database access requirement implementation, project specific training, and/or other tasks associated with the clinical trial database
• Performs data management study close-out activities including finalizing SAE reconciliation, medical coding, and quality control steps in accordance with Standard Operating Procedures
• Performs Business Development functions including but not limited to attendance and participation in client meetings
• Provides operational support for Data Operations
• Serves as data management lead interacting directly with sponsor, sites and vendors on medium complexity paper-based or EDC projects with moderate to minimal supervision

Qualifications

Experience / Education:

• Must have experience with DM start up, maintenance and closeout activities in both paper and EDC studies
• Experience in moderate to complex projects, paper based and EDC Databases. Some global project experience preferred
• Master’s degree or MPH degree required.

Knowledge / Skills / Abilities:

• Must have experience in managing clinical trial databases in Pharmaceutical or related industry
• Familiarity with SAS including basic programming skills a plus
• Must show excellent interpersonal skills
• Ability to effectively communicate issues and potential resolutions to sites, other team members, project manager, and supervisor
• Experience with both paper-based and EDC studies preferred
• Requires excellent oral and written communication skills to interact with investigative sites, sponsors and vendors and to build rapport with each