Associate Director, Process & Documentation Business Planning & Operations, Data Management
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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
Business Planning and Operations (BPO) within the Clinical Programming domain, part of the Data Management (DM) team
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
Serves as a functional process expert with a focus on clinical programming
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 in Clinical Programming (SAS)
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
SO, WHAT’S NEXT?
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.
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AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.
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