The Strategic Projects Lead, Late Phase Data Management is a member of the Late Phase Data Management Leadership Team (DMLT).

As such this role an act as a designee of the Late phase DM Head and is responsible for assigned projects and tasks internally and with DM service providers and alliance/collaboration partners.

The assigned tasks could include oversight, management and delivery of:

• DM related improvement projects and initiatives on project, program and/or executive level, including DevOps/R&D/AZ level initiatives as required
• Leading, managing or contributing to AZ portfolio deliverables, such as development alliances and partnerships and managing/facilitating global DM input and representing AZ DM in such alliances (Examples (not limited to): Daiichi Sankyo, Acerta)
• Collaboration in service provider managed initiatives and managing vendor deliverables and KPIs in collaboration with other DMLT members as applicable
• Collaboration in initiatives with other functions
• Defining, harmonizing, and measuring the internal performance metrics for whole DM function and as well as applicable and relevant external vendor KPIs/status reporting as agreed. 
• Other tasks in support of AZ portfolio delivery on behalf of DMLT.

As a matrix leadership role, this position leads, mentors, or drives other DM functions in development of their areas, procedures and processes, especially as a result of improvement initiatives and influences BaU process in collaboration with DMLT, while ensuring alignment across the Early and Late DM space and broader into Biometrics Data operations and other departments.  This position may have direct or indirect reports depending up initiative assignments.

In portfolio related tasks, projects and initiatives, the role will report dotted line to DM TA Head of relevant TA.

This role is expected to provide DM leadership and influence in to BDOLT, TA aligned biometrics, Regulatory, Patient safety and other functional colleagues/groups as required (e.g. GPT, CPT, etc.), as part of or connected to initiatives, assignments and governance interactions.

Typical Accountabilities:

• Establish and maintain strong relationships with collaborators and suppliers, to enable fit for purpose delivery of clinical trial data

• Serves as the expert in Clinical Data Management to provide oversight and advice to all staff within and out of the function regarding process around DM deliverables and initiatives
  • Develops and maintains performance KPIs to ensure delivery excellence.
  • Liaises with external departments such as Compliance, Quality Assurance, Regulatory, Procurement, IT, Alliance Management, etc. as a decision maker as delegated by the the Head of DM.
  • Operationalizes vision and defined objectives into actionable assignments which may be executed as an independent contributor or oversite of multiple teams of individuals executing the work initiative streams.
  • Manages one or more subornment senior specialists in a matrixed leadership role engaged in process assessment and design for DM and other functions
• Serves as the expert in Data Management process to provide advice to the clinical project team regarding the DM activities and deliverables.
  • Monitors industry developments within DM and technology space for consideration, planning and implementation
  • Contributes to all aspects of DM business, development of future strategies, and processes
  • Maintains operational environment with regulatory compliance, industry initiatives and/or technical advances
  • Develops and integrates clinical project standards and processes based on industry best practices
  • Assesses DM needs and areas of improvement and recommends changes to the operating model with DM Leadership
  • Provides DM process expertise for Global Clinical Development Initiatives as required

• People management and development:
  • Builds and maintains strong partnerships with internal teams and external partners to ensure clinical data is of high quality, delivered on time, and within budget.
  • Ensures optimum performance of group function. Recommends and implements techniques to improve productivity, increase efficiencies, reduce costs, and maintain state-of-the-art practices
  • Leads multiple concurrent DM procedure and policy related initiatives with additional reach of leading/executing broader Biometrics cross-department and/or AZ Enterprise initiatives.  Initiative assignment leadership requires budget creation and management, payment authorization, schedules, planning design, and execution.  Assignments are objective-based aligned with corporate, Clinical Biologics, Biometrics, or DM strategic roadmap. 
  • In a matrixed leadership role frequent interaction with senior leadership is expected both internally and externally facing vendors

Qualifications:

• 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, and people management skills
• Ability to work independently, under pressure meeting tight deadlines, demonstrating high level of initiative and flexibility.
• Excellent organizational and analytical skills
• Strong technical and problem-solving skills with
• 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.