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About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Director, Clinical Data Strategy & Operations, Specialty

Madison, New Jersey Req ID 2208687 Category Research and Development Division AbbVie
  • The position has responsibility for understanding the demands of the business as well as the changing needs of the organization,sourcing and implementing new technology to meet business needs, and staying current with industry practices.
  • This responsibility includes the creation and translation of a business vision into strategies that maximize organizational performance.
  • The position is responsible for delivering high operational service levels, client satisfaction , and ensuring that data management applications and processes are aligned with clinical development strategic and operational objectives.
  • Manage relationships with all global project teams, understanding their needs and assuring that cost effective solutions are created to meet those needs. Identify global opportunities for efficiencies and implement appropriate cost reduction programs.
  • Ensure that global processes/SOPS are established
  • Ensure processes and standards are globally defined and utilized.
  • Ensure clinical trial management plans are prepared and approved within established deadlines,complying with all applicable project and global standards .
  • Ensure that study documentation across sites are kept current, readily accessible, and compliant with global documentation standards.
  • Ensure Data Sciences activities, processes and technology are fully integrated and meet all applicable project and global standards and expectations. Allocate global resources to maximize efficiencies. Recruit and develop individuals to maximize the collective skills to the organization.
  • Provide coaching and direction to further enhance Data Science capabilities and performance. Lead and develop direct reports to plan, schedule , and monitor work to ensure all project objectives are met. Oversee study and project budgets, monitoring actual versus planned costs. Act as functional head of DM Ops across all global sites. Collaborate with global site heads with regard to HR concerns, site performance , staffing , and resource utilization.
Qualifications:
  • 10+ years experience in clinical development in pharmaceutical or related industry
  • 5+ managing matrixed and/or direct reports
  • Experience in clinical data management processes and systems with:Experience leading change implementation Experience leading clinical trial process development Experience supporting clinical trials
  • Client relationship management
  • Negotiation and conflict management
  • Excellent written and verbal communication
  • Problem solving
  • Staff development
Significant Work Activities: N/A
Travel: Yes, 15 % of the Time
Job Type: Experienced
Schedule: Full-time
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