Director Clinical Data Management - Rare Disease

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Job Description

Director Clinical Data Management

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What You Will Do

Let’s do this. Let’s change the world. The Amgen Global Clinical Data Management team is looking for an experienced Director to lead our data management team on the aspiration of optimizing and delivering an industry admired clinical evidence platform to deliver innovative medicines to patients with unmet medical needs.

The Director is accountable for leadership and oversight of the data management organization; ensuring operational excellence and consistency in clinical trial execution. They are accountable for building and developing a high performing internal data management team, as well as ensuring engagement and alignment of Amgen’s strategy and priorities with the Functional Service Provider (FSP).

The Director is also part of the Global Study Operations (GSO) leadership team, accountable for the delivery of quality clinical trials through industry-leading execution of innovative processes, strong cross-functional partnerships, and best-use of clinical systems and analytics to guide site and study operations. The role will support acceleration of clinical programs and other continuous improvement efforts, applying innovative thinking in shaping future strategy.

Our Global Clinical Data Management Team:

The Global Clinical Data Management Team comprises approximately 50 people. The three Directors, as part of the wider GSO organization and reporting into the Executive Director, Global Study Operations, work together to meet the demands of an industry leading, fast paced, high throughput organization with a commitment to compliance, quality and standards.

Director Clinical Data Management role overview:

You will lead and manage Data Management (DM) teams within a specific DM operational business unit. The Director will set and drive forward the vision and strategy for DM as a member of the DM and GSO Leadership Team.

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
   

Win

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The data management professional we seek is a collaborator with these qualifications.

Basic requirements:

Doctorate degree and 4 years of data management experience
OR
Master’s degree and 8 years of  data management experience experience
OR
Bachelor’s degree and 10 years of  data management experience experience

In addition to meeting at least one of the above requirements, you must have at l