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 role holder will be responsible for developing the Clinical Data Management (CDM) strategy for either the therapeutic area and/or the execution strategy at the process level. Will be responsible for global processes, CDM quality, management of external partners, internal training, and delivering against metrics for the CDM Function. Will be a member of the Data Management Leadership Team (Early or Late) and is expected to provide CDM expertise to influence decision making with the relevant partnering teams i.e. Biometric Data Leadership Team, TA aligned Biometrics team, Regulatory, Patient safety and other functional colleagues. Will be responsible for managing a team of Clinical Data Management specialists in one or more countries, that are assigned to clinical drug/non-drug projects. Will drive a culture of delivering to established milestones with the highest degree of customer satisfaction, emphasizing communication and transparency of operations. 

Typical accountabilities:

• Establish asset level strategies to ensure consistency, efficiency, and excellence in the application of CDM standards, implementing advanced predictive data monitoring practices and knowledge sharing within a TA.
• Execute the CDM Leadership strategy for the relevant TA or processes, ensuring alignment with the vision, principles, and strategy of partnering teams i.e. Dev Ops Biometrics Data Operations, TA-wide or process business strategy. Full decision-making responsibility for all aspects of CDM execution at the TA or process level.
  • Capacity Management and Alignment for DM:  Ensure appropriate resources are available (internal and/or external) and assigned appropriately to meet demand of CDM function
  • Manage relationships with internal and external partners to ensure the CDM strategy is appropriate in the wider context i.e. TA Directors, Training and Risk Management, Quality Management, Statistics and Programming, Study Management Teams, Digital Health, external vendors.
• Ensure 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
• Serves as the expert in Clinical Data Management to provide oversight and advice to all staff within the function regarding process around EDM deliverables and compliance
• Accountable for development and maintenance of vendor relationships and contracts, maintaining strong relationships to enable fit for purpose delivery of clinical trial data in line with established agreements.
• Establish and monitor relevant indicators of group performance; use these to continuously improve clinical data management services. Evaluates resource gaps and create headcount requests and justification.
• Accountable for assessing quality gaps and CAPA submissions, determining isolated events from systemic issues and developing improved process mitigation strategies and trainings.
• Partner with Standards Group and Study Management 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
• Accountable for driving team performance and authority to assign work to staff in more than one country in CDM.  Serves as an escalation point to direct reports.
• Attract, develop and retain top talent; provide direction, real time situational mentoring, career development guidance.  Actively work to promote team building and positive culture within the department
• May act as designee of the DM Head where appropriate

Requirements:

• University or college degree in the life sciences or related subject, pharmacy, nursing or equivalent relevant degree. Advanced degree is a plus but not mandatory
• 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 experience on computer systems for Data Management.
• Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP) and relevant regulatory requirements
• Experience with Clinical Trial Operations and a clear understanding of clinical data from internal as well as external sources
• 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)
• Expert reputation within the business and industry (desirable)
• Extensive knowledge of the latest technical and regulatory expectations (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.