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.

Senior Clinical Development Leader oversees the Clinical Database Development (CDD) deliverables on therapeutic or technical area level ensuring harmonization and standardization of clinical databases across clinical studies within the therapeutic or technical area. An expert on CDD processes, standards and technology. Supports the Clinical Project Teams (CPT) with technical expertise in clinical databases. Responsible to ensure CDD deliverables follow standards and meet data quality on therapeutic or technical area level. Maintains Business Continuity for CDD processes and standards including integrity of the clinical database for the relevant therapeutic or technical area.

Typical Accountabilities:

• Accountable for oversight on standardization and harmonization of clinical database deliverables across clinical projects in the therapeutic or technical area
• Provides project level technical expertise to Clinical Project Teams, data management, medical, analysis and reporting and study management teams throughout all study start up activities in therapeutic or technical area
• Works in collaboration with the clinical project level representatives of other technical groups, data management, analytics and reporting to define harmonized requirements for delivering clinical studies across the therapeutic or technical area
• Works in collaboration with the standards group for defining and maintaining therapeutic or technical area level standards related to clinical database development
• Ensures compliance to GCP, GAMP and other global guidelines in delivering clinical databases for clinical studies across the therapeutic or technical area
• Provides expertise in solving complex programming requirements related to CDD
• Governs the Clinical Data Management Systems global and program standards libraries for the therapeutic or technical area
• Leads projects to automate, simplify and innovate in order to ensure that the team is industry leading
• Supports the organization in defining the digital strategy for delivering future CDD activities
• Accountable for delivering CDD activities within budget for the managed therapeutic or technical areas
• Accountable for appropriate resourcing of managed therapeutic or technical areas
• Accountable for appropriate training of reporting teams within managed therapeutic or technical areas
• May act as backup for the Head of Clinical Database Development
• Mentor and train Database Developers

Qualifications :

• Bachelor's degree, preferably in computing or scientific discipline
• 10+ years database development experience in the pharmaceutical industry working with clinical trial data.
• 5+ years line management experience
• Experience in working with matrix organizations
• Excellent Clinical trial knowledge
• Excellent organizational and analytical skills and high attention to detail
• Excellent written and verbal communication skills, organized and ability to lead tasks from concept to delivery
• Excellent planning, resource and project management skills
• Excellent understanding of clinical data system design / development / validation and system interoperability.
• Ability to work independently without close supervision
• Ability to work in a global team environment

Desirable:

• Vision to deliver digital strategy for Clinical Database Development
• Excellent knowledge of clinical and pharmaceutical drug development process
• State of the art understanding of data standards (CDISC) and practices as they apply to CRF design, clinical data tabulation, database development, data handling and reporting
• Excellent ability to work effectively with external partners
• Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement
• Experience with Medidata's Rave Study Build
• Experience in Medidata Rave Custom Functions
• Experience or knowledge of Rave Safety Gateway, TSDV
• Experience with object-oriented programming using .NET technologies, C#, Visual Basic, MS SQL, SAS, Python, APEX, PL SQL, XML, Java an advantage
• Experience with reporting environments Crystal Reports, Business Objects, Tibco SpotFire, PowerBI, Tableau

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.