Associate Clinical Data Management Director

Role Summary

Provide oversight for the execution of data management activities at the program level for oncology studies from study start up through regulatory submission. May serve as the lead study data manager for large, complex trials or multiple smaller studies, collaborating with cross-functional teams and external partners. Support CDM process improvement and participate in staff recruitment, onboarding, training, and mentoring.

Responsibilities

• As the main point of contact to the Study Team, collaborate with cross-functional team members to meet project deliverables with quality and per agreed timelines
• Lead the planning and execution of data management activities on assigned studies
• Ensure all Data Management study documents are developed and archived
• Establish and lead the Data Working Group (DWG) for the assigned study
• Develop and maintain Data Management timelines
• Track and manage progress towards data deliverables through metrics tracking, analysis, and reporting
• Identify and mitigate risks to Data Management deliverables; resolve data handling related issues
• Provide expertise in data management to support clinical studies; deliver clear information and hands-on support to project teams and CROs related to eCRF and database design, data quality, and reporting
• Develop and execute procedures for data quality review and data acceptance prior to analyses and/or database lock
• Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA/WHO-DD coding
• Support transfer, locking, and archiving of study databases; manage scheduling across multiple projects
• Prepare recommendations for new or improved data management processes
• Work with cross-functional stakeholders to ensure timely project deliverables
• Direct and oversee activities of Data Management staff assigned to studies
• Perform project-level resource management in conjunction with CDM Management
• Lead electronic submission activities for Data Management as appropriate
• Participate in selecting outsourcing partners, including input to RFPs, reviewing proposals, and vendor oversight
• Develop and execute study-specific training within projects
• Lead or participate in CDM process improvement initiatives; promote CDM internally and externally
• Direct activities and hold accountable junior data managers and/or data review teams

Qualifications

• BS/BA in a related discipline with a minimum of 11 years of related experience; or MS/MA with a minimum of 9 years; or PhD with a minimum of 5 years; or equivalent combination of education and experience
• May require certification in the assigned area
• Typically requires a minimum of 9 years of related experience; a minimum of 7 years in clinical data management in the pharmaceutical industry or clinical trials; and a minimum of 4 years in a project leadership role
• Experience with Electronic Data Capture (EDC) required; IVRS/IWRS experience preferred
• Demonstrated experience leading data management teams preferred
• Knowledge of GCP essential; general knowledge of FDA regulations governing clinical trials and EDC systems required
• Expertise in CDASH/CDISC standards preferred
• Strong analytical and business communication skills; excellent verbal and written communication

Skills

• Problem solving with people and project leadership skills
• Strong knowledge of data management concepts and processes
• Ability to resolve complex issues creatively and effectively
• Ability to manage multiple projects and vendors; strong organizational skills
• Strong data governance and quality assurance capabilities
• Proficiency with data standards, data transfer, and database management

Education

• BS/BA in a related discipline; or higher degrees as noted in qualifications

Additional Requirements

• Not specified