Associate Director, Process & Documentation Business Planning & Operations,

at  AstraZeneca

WHY JOIN US?

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, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.
The Associate Director, Process & Documentation for Data Management (DM) plays a pivotal role in promoting and branding Data Management. This position ensures the efficiency of business operations and implements necessary changes or improvements to processes and documentation. The role involves planning and leading strategies for process simplification and harmonization, ensuring effective communication across stakeholders and end users. The AD provides functional process expertise, working closely with Subject Matter Experts within and beyond the functions. This role is crucial in promoting and communicating DM activities to stakeholders across the business and externally. The AD also serves as an expert in Clinical Data Management Process development, offering oversight and advice to SMEs regarding CDM Governing documentation development and maintenance. Monitoring regulatory, technical, and pharma-industry trends to implement continuous process improvements is a key responsibility. This position collaborates with other Associate Directors to strengthen the infrastructure of the function.

ACCOUNTABILITIES

• Accountable for reviewing and updating processes to ensure DM deliverables are met in a harmonized, simplified manner while remaining compliant with HA guidelines and ensuring quality and GxP compliance
• Develops strategies for effectively communicating process changes internally and externally
• Brings a six sigma approach to processes to ensure best practices are upheld
• Evaluates and improves business processes, brainstorming and collaborating with teams for new ideas
• Monitors and assesses processes to ensure desired outcomes in close collaboration with Business Process Management
• Liaises with counterparts in Process and Enablement to ensure company SOPs are updated as necessary
• Develops high-quality, informative communications that brand DM
• Ensures all messaging aligns with key business strategies
• Develops content for social media, newsletters, town halls, and other distribution channels
• Produces videos detailing who we are and what we do
• Develops reports showcasing activities in Data Management
• Creates questionnaires to gather feedback from stakeholders and baseline business
• Collaborates closely with cross-functional colleagues to ensure connectivity and dependencies of DM processes on other functional processes are considered
• Leads, facilitates, supports work in the ECMS tool
• Acts as SOP steward and trainer with functional SME support
• Manages and coordinates resource assignments for review cycles of governing documentation
• Represents DM as SME during activities associated with LSI governing documentation system (AZDoc & AZLearn)
• Partners with LSI colleagues to ensure appropriate training curriculum for DM staff
• Translates business objectives into individual assignments/tasks
• Collaborates with Biometrics, Data Management, Clinical Operations, and partner CRO organizations to ensure coordination, compliance, and proper use of DM Processes
• Leads creation of workstreams for developing new CDM governing documentation
• Provides oversight and advice on creating SOPs, Guidelines, Job Aids, supporting templates, and forms
• Offers expertise and consultancy to TA Leads on interpreting CDM governing documentation

ESSENTIAL SKILLS/EXPERIENCE

• Bachelor in scientific discipline or related field with a strong understanding of biomedical data and analytics. Advanced degree is a plus
• Relevant experience in a pharmaceutical, biotech, CRO or Regulatory Agency
• Experience as a project manager and subject matter expert of special initiatives supporting DM activities
• 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 of computer systems for Data Management
• Excellent understanding of clinical trial methodology, GCP, ICH, GCDMP, and medical terminology
• Experience with technologies and best practices across multiple platforms
• Demonstrated experience supporting complex projects and cross-functional teams including delivering to project and portfolio metrics
• Excellent communication, interpersonal, and negotiating skills relating to colleagues and associates internal/external to the organization
• Strong track record of building successful relations with supervisors, peers, suppliers, customers, partners, and stakeholders is essential
• Strong strategic experience and business analytics ability to distill research needs and define business, technical, and operational requirements
• Strong team player

DESIRABLE SKILLS/EXPERIENCE

• Ability to multitask and monitor several activities on a daily basis
• Six Sigma green belt certified
• Ability to coach and mentor
• Ability to take initiative to develop new strategies and outside-the-box ideas for social media
• Excellent media relations skills

Please refer the Job description for details