The Associate Director, Clinical Data Management will handle and manage data management (DM) activities for all phases of clinical trials (Phase 1-4) including oversight of CRO data management activities and management of the quality of data management deliverables. The Associate Director, Clinical Data Management will also oversee activities/assignments for contract employees and may manage Akebia DM staff as applicable.
Required Skills
- Provide leadership and contribute to strategy decisions regarding data management solutions for Akebia
- As a member of the clinical study or project team, ensures oversight of the Data Management external service providers; provides status reports/updates, resolves disputes, and ensures timely acquisition of high-quality deliverables from the external service provider
- Provide oversight and participate in study setup and initiation procedures such as CRF design, database design, edit check design/review, DMP (Data Management Plan) review/approval and annotated CRF design
- Ensure accuracy, completeness, and consistency of clinical trial data by performing or managing CDM staff in the oversight of data collection and data cleaning final quality review activities, the review of analysis tables, listings, and figures and archiving study databases and supporting documents
- Apply experience and education to initiate and develop new and more efficient processes and procedures for study setup, maintenance, closure and archiving activities to meet business needs
- Develop and implement changes to DM guidelines and quality processes to ensure clinical databases, external data files and analysis datasets are designed in a standard, accurate, complete and consistent format conducive to analysis and regulatory submissions
- Coordinate the acquisition and development of tools to support data management tasks internally and externally with DM vendors
- Contributes to regular budget forecasting and cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results
- Ensure that optimal relationships are developed with internal customers/colleagues and with new or existing strategic partners/vendors
- Mentors team members, junior staff or contractors via matrix relationships (internally or at external service providers) or direct supervision, by directing work, resolving problems and/or providing guidance
Required Experience
Basic Qualifications:
- BA/BS Degree
- Minimum 8 years of experience as a Data Manager in a CRO or pharmaceutical/biologics/biotechnology company.
- Experience as lead CDM managing studies from start-up through close-out (including data management activities related to study conduct, study completion and archiving of study materials)
Preferred Qualifications:
- BA/BS degree in a scientific discipline
- Experience with managing direct reports
- Ability to communicate data management standards, developments, and challenges in an accurate, concise, consistent, organized and grammatically/situationally correct manner to both internal and external audiences
- Comprehensive understanding of DM responsibilities and project activities (i.e. budget, timelines, resources) and of linkages with tasks and responsibilities of other functions
- Capable of prioritizing individual and CRO/Vendor tasks based on timelines and study needs
- Extensive experience with all study phases and with large, complex clinical programs
- Experience managing junior staff
- Ability to use metrics to determine project status, monitor internal/external DM team progress and plan for project resources and monitor project budget
- Ability to propose areas for development or process improvement and assist with staff compliance
- Ability to apply technical knowledge to work activities and use critical thinking skills for problem identification and solving
- A demonstrated proficiency in efficient database and/or SAS dataset design
- Familiarity with ICH GCP as well as full knowledge of industry practices and standards (CDISC, SDTM, CDASH)
- Ability to prioritize and effectively manage several large projects simultaneously
- Capacity to work with little or no supervision with accuracy and thoroughness
- Excellent written and oral communication skills