Lead/Senior Lead Clinical Data Management - IQVIA Biotech at IQVIA

BASIC FUNCTIONS:

• Lead/Senior Lead Clinical Data Manager position is to manage all data management (DM) tasks to include more complex and/or larger studies and/or a program of studies from start-up through database closure and archival producing high-quality databases for analysis and potential regulatory submissions.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• Manages DM-related aspects of the program and/or project
• Collaborates with the project team on overall data management strategy for the program and/or projects, assuring overall quality and efficiency
• Represent DM as the functional lead at internal and sponsor project team meetings
• Provides proactive, timely communication of project status, data trends and issue resolution with internal team and Sponsor
• Develops, generates and analyzes project progress and/or metric reports, reporting summary of findings and remediation activities, as required, to DM management, project team and Sponsor
• Assumes ownership for DM project deliverables within DM scope of services including creation and management of DM-specific timelines and providing resource and budget projections
• Discusses roadblocks to DM deliverables and potential strategies for overcoming with project team and/or DM management and implements solutions
• Performs peer reviews of key DM study documents or other DM deliverables to assure quality of content and, where appropriate, consistency across a program of studies
• Reviews and provides DM staffing projections for program and/or projects
• Presents EDC and/or CRF completion at Investigator Meetings
• Participates in regulatory and Sponsor audits for program and/or projects
• Oversees daily team member activities
• Serves as a Data Management team leader
• Reviews DM team member activities and deliverables to ensure plans and processes are followed
• Assures project activities are performed within budget and according to expected timelines and meet high quality standards.
• Reviews resource allocation with the assigned DM project leads to ensure projects and budgets are managed effectively
• Provides training of DM staff on project specific processes
• Oversees the DM project and/or program team and performs DM tasks, as required, based on the approved Data Management and Data Review Plans
• Oversees System Development and Modifications
• Oversees System and Data Listing Testing Activities
• Develops, Maintains and Archives DM Project Documentation
• Represents Data Management at Bid Defense Meetings (BDM)
• Continuous improvement

KNOWLEDGE, SKILLS AND ABILITIES:

• Ability to collaborate and strategize with both technical and clinical team members (CRAs, Safety, Biostatistics, etc)
• Ability to effectively communicate technical issues to non-DM team members and Sponsor
• Ability to maintain positive and open relations with internal, sponsor, and vendor team members
• Ability to facilitate team meetings ensuring accurate attendees and take meeting minutes
• Ability to develop study-specific procedures
• Knowledge of clinical trials concepts
• Ability to create detailed DM project instructions and documents (CRF Completion Guidelines, Database design documents, edit check specifications, Data Review Plan, etc.)
• Proficiency with multiple clinical EDC systems (preferred systems are InForm and Rave)
• Proficiency with IQVIA Biotech SOPs, WPs
• Efficient with organizational skills to meet established timelines
• Organized and thorough with attention to details
• Proficiency in computer applications and time management tools (e.g., MS Office)

MINIMUM RECRUITMENT STANDARDS:

• Bachelor’s degree, or educational equivalent, in clinical, biological or mathematical sciences, or related field, or nursing qualification

7 years of experience in clinical trials within a similar function, including:

• proven competence in managing delivery of multiple projects / programs independently through full data management study life-cycle
• Proven Lead experience
• experience in handling bid defense meetings
• Equivalent combination of education, training and experience