Manager, Data Management

KEY TASKS & RESPONSIBILITIES

• Acts as the key scientific and technical data management expert; define and drive the data management strategy and standards for the Therapeutic Areas (TA) as well as Risk Based Monitoring (RBM) standards, tools, data provisioning, and reporting
• Manage the data management delivery team and develop the capability for the group to support the existing workload while building expanding the capability as necessary to support the growth of the organization
• Ensure Data Management deliverables meet/exceed project/study team expectations regarding quality, time, and cost and that Data Management documentation is filed/archived according to applicable eClinical Solutions and regulatory requirements
• Subject matter expert of end-to-end study execution, inclusive of cross-functional core teams to optimize study-specific clinical trial processes
• Manage a team of study leads, responsible for data management task, ensuring target dates are met, risks identified and escalated as necessary
• Provide technology expertise and guidance business development/sales opportunities
• Develop staff and provide clear performance targets for appraisal
• Participate in expert working groups/innovation discussions
• Champion of the elluminate DM tools
• Provide project and strategic consulting and management activities while delivering the highest degree of quality, optimizing efficiencies, and ensuring consistency and repeatability
• Develop, implement, and execute data management strategies to allow Clients to better leverage their clinical data through elluminate Data Central and analytics modules
• Develop a mindset throughout the organization that will foster intimate customer relationships resulting in account growth and repeat business
• Dual Role comprising of operational leadership and study data management
• Mentor and assist with the growth of all data management employees by recruiting, developing, and retaining top performers
• Regularly present updates on the status of the Data Management team to the eClinical Leadership Team and others, as required
• Contribute to and monitor eClinical Solutions division and project financials with a focus on annual budgets versus actual revenue, gross margin, and net profit targets
• Monitor and interpret key performance indicators (KPIs), metrics, dashboards, Clinical Trial Operational Analytics (CTOA), and reports to provide actionable recommendations to eClinical Leadership Team and others, as required
• Interact with multiple vendors including clinical CROs, lab vendors, IVRS on assigned projects to ensure data needs are met
• Ensure compliance with eClinical and industry quality standards, guidelines, and procedures
• Proactively address any/all issues as and when appropriate
• Identify and promote appropriate training and development programs for staff
• Act as DM representative at industry meetings/conferences
• Other duties as assigned

CANDIDATE PROFILE

Education & Experience

• Bachelor s degree in health-related field or equivalent experience preferred
• 15+ years experience working in the Life Sciences industry preferred
• CCDM certification preferred

Professional Skills

• Strong project management experience and project team leadership skills, with significant experience supporting Pharmaceutical / Biotechnology / Medical Device organizations in a consultative role preferred
• Ability to proactively detect and act upon identified clinical data trends
• Strong project management skills and experience with scope management, resource management, financial management, project planning and resource allocation
• Demonstrated experience managing complex client relationships requiring multiple DM services and projects
• Strong data management and EDC experience required
• Strong prior customer interface experience with a demonstrated ability to develop, maintain and grow strong Client relationships
• Proven ability to motivate and mentor data management staff resulting in a world-class delivery team
• A detail-oriented team player with strong organizational skills and the ability to multi-task, prioritize and plan within a high-energy, solutions-based environment where the customer comes first.
• Excellent command of the English language (both written and verbal)

Technical Skills

• Proficiency in Microsoft Office Applications
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology
• Strong familiarity with EDC and Clinical Data Management Systems: Medidata Rave is preferred
• Experience with project and budget tracking
• Experience with Cloud SaaS platforms (preferred)
• Experience with data reporting tools such as Qlik, JReview, Spotfire preferred
• Experience with RBQM methodology
• Demonstrated working knowledge of CDISC guidelines and standards