Associate Director, Process & Documentation

AstraZeneca • Durham, NC

17h

About The Position

The Associate Director, Process & Documentation for Data Management (DM) is a pivotal role focused on enhancing the efficiency of business operations and promoting Data Management. This individual is responsible for creating and implementing changes and improvements to processes and documentation, as well as leading the strategy for process simplification and harmonization, ensuring effective communication across all stakeholders and end users. The role provides functional process expertise, collaborating closely with Subject Matter Experts (SMEs) within and outside the functions. Key responsibilities include promoting and communicating DM activities internally and externally, serving as the expert in Clinical Data Management Process development, and offering oversight and advice to SMEs on the development and maintenance of CDM Governing documentation. The Associate Director will monitor regulatory, technical, and pharma-industry trends to drive continuous process improvements and will collaborate with other Associate Directors to strengthen the overall infrastructure of the Data Management function.

Requirements

• Bachelor in scientific discipline, or related field with a strong understanding of biomedical data and analytics
• 5+ years of 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 to support complex projects and cross functional teams including delivering to project and portfolio metrics
• Excellent 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, 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
• Strong team player
• 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

Nice To Haves

• Advanced degree is a plus

Responsibilities

• Accountable for the review and update of processes to ensure that DM deliverables can be 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
• Able to bring a six sigma approach to process to ensure best practices are being upheld
• Evaluate and improve business processes
• Brainstorm and collaborate with teams for new ideas to enhance processes
• In close collaboration with Business Process Management, continue to monitor and assess processes to ensure they are producing the desired outcomes
• Liaises with counterparts in Process and Enablement to ensure that company SOPs are updated as necessary
• Develop and produce high-quality, informative, and interesting communications that brand DM
• Ensure all messaging aligns with key business strategies
• Develop content for social media, newsletters, town halls and any other distribution channels
• Produces videos to detail who we are and what we do
• Develop reports that showcase activities in Data Management
• Develop questionnaires that allow us to get feedback from stakeholders and baseline our business
• Collaborates closely with cross-functional colleagues (e.g. in SM&M, Study Management, Programming) to understand and ensure connectivity and dependencies of DM processes on other functional processes are thoroughly considered when providing FPE input or working with PES to update processes
• ECMS - Leads, facilitates, supports work in the tool
• SOP steward and trainer, with functional SME support
• Manages and coordinates the assignment of resources for the review cycles of Biometrics, Data Management and Clinical Operations owned governing documentation and determines the appropriate CDM SME involvement in the review of such documentation
• Interacts with Learning, Standards & Insights (LSI), Clinical Directors and CBDM Directors in this capacity
• Represents and serves as the SME for Data Management during activities associated with all aspects of the LSI governing documentation system (AZDoc & AZLearn)
• Partners with colleagues in LSI to ensure appropriate training curriculum is in place for DM staff
• Translates business objectives into individual assignments and/or tasks
• Collaborate and communicate with Biometrics, Data Management, Clinical Operations and partner CRO organizations to ensure coordination, compliance and proper use of DM Processes in data standards, database builds, programming and/or reports in clinical studies
• Leads the creation of the workstreams for developing new CDM governing documentation and supporting documentation
• Provides oversight and advice to the workstream regarding the activities of creating SOPs, Guidelines, Job Aids and supporting templates and forms
• Provide expertise and consultancy to TA Leads on interpretation of CDM governing documentation to ensure overall CDM quality and consistency

Benefits

• qualified retirement program [401(k) plan]
• paid vacation
• paid holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans
• short-term incentive bonus opportunity
• eligibility to participate in our equity-based long-term incentive program (salaried roles)

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees