At AstraZeneca we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

The Director of Clinical Data Management is a member of the Clinical Data Management Leadership Team (CDMLT).  As such, this role is responsible for developing the TA strategic strategy and global execution plans for Clinical Data Management (CDM) that is aligned with the Clinical Data Management Leadership Team and GMD Clinical Operational Leadership Team vision and principles, 

The CDM TA Head will establish asset level strategies and tactics to ensure consistency, efficiency, and excellence in the application of standards, establishment of advanced, predictive data monitoring practices from database activation through database release and submission, and knowledge sharing within a TA.  The role is responsible for driving a global culture of delivering to established milestones with the highest degree of customer satisfaction, emphasizing communication and transparency of operations. 

The role has formal authority to decide and/or assign work to staff in more than one country in Clinical Operational Hubs or functional operational teams.    This includes partnering with CDM Associate Directors or Global Data Management Leaders (GDMLs) in Clinical Operational Hubs to discuss and assign development opportunities as appropriate, or to serve as an escalation point to provide guidance to Clinical Data Management Staff on a global scale that are assigned to clinical drug project and non-drug projects to ensure timely and high-quality data management deliverables.

This role is expected to provide CDM leadership and influence in to Clinical Operation Leadership Team (COLT), GMED, B&I, Regulatory and other functional colleagues/groups as required (e.g. GPT, CPT, Cancer Enterprise, etc.). 

Typical Accountabilities:

• Execute the Clinical Data Management Leadership strategy that is aligned with GMD Clinical Operations organization vision, principles, and strategy at TA level.
• Global Position with full global level scope and decision-making responsibilities for TA
  • Global Capacity Management and Alignment for DM within the TA:  Ensure appropriate resources are available (internal and/or external) and assigned appropriately to meet demand of data management function
  • Key Interactions:  TA Directors, GPT/CPT members, GMED, B&I TA Heads (Programming, Biostatistics), Cancer Enterprise (Oncology and I/O).
  • Secondary interaction:  Study Teams, SMO Directors/Hub Managers, DCDs/ADCDs, GMED/Safety, Enablement Heads
• Ensure globally, that clinical trial data provided for exploratory or reporting purposes are high integrity, high quality, timely and fit for purpose to meet the needs of the Clinical organization
• Establish leading and lagging indicators of group performance; use these to inform continuously improving clinical data management services
• Partner with B&I Standards Group and Clinical Operations colleagues to support portfolio and TA level data standards to enable the right balance of efficiency, flexibility and value in how data is handled and used
• Establish and maintain strong relationships with collaborators and suppliers, to enable fit for purpose delivery of clinical trial data
• Attract, develop and retain top talent; provide direction, real time situational mentoring, career development guidance.  Actively work to promote team building and morale within the department

Requirements:

• Bachelor or Master degree in Biological Sciences, Statistics, IT or related field with a strong understanding of biomedical data and analytics. Advanced degree is a plus
• At least 10-15 years relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency
•  Strong leadership capabilities including ability to drive strong following in reporting lines
• Experience with Clinical Trial Operations and a clear understanding of clinical data from internal as well as external sources
• Demonstrated knowledge of regulatory requirements supporting clinical trials and submissions
•  Demonstrated experience to manage complex projects and cross-functional teams including delivering to project and portfolio metrics
•  Demonstrated strong communication, interpersonal and negotiating skills in relating to colleagues and associates internal/external to the organization and leveraging of those competencies to ensure continuous progress 
• Strong track record of building successful relations with supervisors, peers, direct reports, suppliers, customers, partners and stakeholders is essential
• Strong strategic experience and business analytics ability to distil research needs and define business, technical, and operational requirements
• Certified Clinical Data Manager (CCDM) via the Society of Clinical Data Management (desirable)

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.