Director, Clinical Data Management

Here you’ll have the opportunity to make a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.

With our ground-breaking pipeline, the outlook is bright. Be proud to be part of a place that has achieved so much, yet is still moving forward. There’s no better time to join our global, growing enterprise as we lead the way for healthcare and society

As Director, Clinical Data Management you 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. Responsible for global processes, CDM quality, management of external partners, internal training, and delivering against metrics for the CDM Function. Aa 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. You will be responsible for leading 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 openness of operations.

What you’ll do

• Establish asset level strategies to ensure consistency, efficiency, and excellence in the application of CDM standards, implementing sophisticated 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

• Maintain 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 supervise 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, resolving 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

Essential criteria

• 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 proven experience in a pharmaceutical, biotech, CRO or Regulatory Agency

• Strong leadership capabilities including ability to drive strong following in reporting lines, and people leadership 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 lead sophisticated 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 background of building successful relations with supervisors, peers, direct reports, suppliers, customers, partners and stakeholders is critical

• Strong strategic experience and business analytics ability to distil research needs and define business, technical, and operational requirements.

Why AstraZeneca

At AstraZeneca, we 're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

So, what’s next?

This role is open from 14th June 21 and welcome with your application no later than end of play 23rd June 21

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.