Associate Clinical Data Management Director

Role Summary

Associate Clinical Data Management Director – Provide oversight for the execution of data management activities at the program level from study start up through regulatory submission. May serve as the lead study data manager for a large, complex trial or multiple smaller studies. Support CDM process improvement initiatives. Participate in staff recruitment, onboarding, training, and mentoring.

Responsibilities

• As the main point of contact to Study Team, work collaboratively 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 assigned study
• Develop and maintain Data Management timelines
• Track and manage progress towards data deliverables through effective metrics tracking, analysis, and reporting
• Effectively identify and mitigate risks to Data Management deliverables
• Identify and resolve data handling related issues
• Provide a high level of expertise in data management to support clinical studies
• Provide clear verbal or written information and hands-on support to project team members and to CROs related to eCRF and database design, data quality, and reporting of database / data quality status
• Develop and execute procedures for data quality review and data acceptance prior to data analyses and/or database lock
• Manage data transfers with CROs and third-party data sources, SAE/AE reconciliation and MedDRA /WHO-DD coding
• Support the transfer, locking, and archiving of study databases. Manage scheduling and time constraints across multiple projects
• Prepare recommendations for new or improved processes for data management and data flow
• Work collaboratively with cross-functional stakeholders to ensure project deliverables and timelines are met
• Direct and oversees activities of Data Management staff assigned to studies and tasks within projects
• Perform project level resource management in conjunction with CDM Management
• Lead electronic submission activities for Data Management as appropriate
• Participate in selecting outsourcing partners for assigned studies including: Input to Request for Proposal (RFP); Review proposals; Participate in evaluation/audits and capabilities presentations; Review project scope of work documentation; Provide oversight of vendors providing Data Management services
• Develop and execute study specific training of staff within a project
• Lead or participate in CDM process improvement initiatives
• Promote and be an advocate for CDM internally and externally
• Direct the activities and hold accountable junior data managers and/or data review teams

Qualifications

• BS/BA degree in related discipline and a minimum of 11 years of related experience; or
• MS/MA degree in related discipline and a minimum of 9 years of related experience; or
• PhD in related discipline and a minimum of 5 years of related experience; or
• Equivalent combination of education and experience
• May require certification in assigned area
• Typically requires a minimum of 9 years of related experience and/or combination of experience and education/training
• A minimum of 7 years of clinical data management experience in the pharmaceutical industry or clinical trials
• A minimum of 4 years in a project leadership role
• Experience with Electronic Data Capture (EDC) is required; experience with IVRS/IWRS preferred
• Demonstrated experience leading data management teams preferred

Experience / Skills

• The ability to problem solve and have people/project leadership skills
• Knowledge of GCP is essential
• General knowledge of FDA regulations that govern the execution of clinical trials and EDC systems
• Expertise in CDASH/CDISC standards preferred
• Extensive experience in relevant industry and area of specialization
• Uses professional concepts and company objectives to resolve complex issues creatively
• Identifies and implements methods and procedures to achieve results
• Leads or manages the work of others with responsibility for results, including costs, methods, and staffing
• Performs a variety of complicated tasks with creativity and latitude
• Complete understanding and wide application of technical principles, theories, concepts, and techniques
• Good knowledge of related disciplines
• Strong analytical and business communication skills
• Demonstrated Data Management Project Management skills
• Excellent verbal and written communication and interpersonal skills

Education

• BS/BA, MS/MA, or PhD in a related discipline as listed above