Study Data Manager

• Leads the CDM study team and maintains oversight of all build, conduct and close activities for one or more studies, ensuring fit for purpose quality
• Implements study conventions, processes, knowledge sharing and best practices on assigned study(s)
• Effectively communicates study goals and status of work, including all requirements to CDM study team and stakeholders
• Shares knowledge using relevant forums and communication tools
• Manages CDM study deliverables, including timelines, risks and coordination of cross-functional tasks
• Identifies and escalates study issues appropriately and addresses corrective action plans
• Evaluates the impact of risks, and develops and implements mitigation plans at the study level
• Provides coaching and mentoring on sub functional activities to peer Study Data Managers (SDMs) and associate Study Data Managers (aSDMs)
• Provides timely feedback to individuals and to CDM
• Management, and seeks ongoing feedback for personal development.
• Fosters teamwork
• Develops and maintains working relationships within and outside of CDM at the study level
• Contributes or leads sub functional or cross functional working groups and initiatives
• Adapts to change, E.g. new tools, processes and technology
• Maintains outsourcing relationships and oversight with partners and inputs to CRO selection participation & review of work orders & scope of work (SOW)
• Provides vendor performance oversight on an ongoing basis

Qualifications

• BA/BS degree or equivalent and moderate industry-related experience
• Moderate practical and theoretical expertise within his or her sub function.
• In-depth understanding of the business of his or her sub function and
• the wider CDM organization