Director, Clinical Data Management

Responsibilities

• Oversight of a distinct DM operational unit (e.g. therapy area, cross-product area)
• Recruiting, managing and developing staff
• Global resource planning and assignments
• Setting of functional goals and objectives
• Creating and implementing GSO & DM strategies developing, reviewing, implementing and enforcing data standards
• Ensuring DM processes/systems meet regulatory and business requirements
• Be an active member of the Leadership Team to provide a foundation for GSO success

Key activities will include:

• Team management including performance, coaching and development
• Develop, review and implement policies, SOPs and associated documents affecting DM globally
• Set vision, strategy and direction for DM group; develop annual goals and objectives
• Accountable for and oversee DM FSP relationships; ensuring goals of product areas and systems groups can be met via the FSP
• Define and maintain Service Level Agreements and Key Performance Indicators; including oversight of quality and CAPA management
• Governance oversight -ensure visibility into performance of FSPs to the department
• Sponsor, Lead and participate in cross functional working groups
• Resource and budget management for global function Ensure adequate training and capability within area and be accountable for staff compliance with all DM processes
• Vendor management (development of strategies, contract management, relationship management, etc)
• Respond to audit/inspection findings
• Be accountable for and oversee all study deliverables and submission activities for products within group
• Ensure that status information on DM activities is available and is acted on as needed

Basic requirements:

• 18 to 23

  years of data management experience

Preferred Experience:

• Masters degree or equivalent in life science, computer science, business administration or related discipline
• 10+ years of extensive experience in data management in the Pharmaceutical or Biotech arena
• 8+ years of experience in rare disease therapeutic area, in a leadership role
• Broad experience of working in a global organization
• Experience at or oversight of outside vendors (CROs, central labs, imaging vendors, etc)
• 8+ years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Strategic and innovative thinker with experience of driving operational excellence
• Excellent relationship building skills with the ability to influence and make business impact
• Ability to work collaboratively cross functionally with ability to influence and drive decisions
• Proven experience within oversight of clinical research suppliers
• Project management
• Previous experience in a global, matrix organization
• Excellent organizational and interpersonal skills
• Ability to anticipate and problem solve challenging issues.