Associate Director, Process & Documentation

AstraZeneca • Durham, NC

1d

About The Position

The Associate Director, Process & Documentation for Data Management (DM) plays a key role in promoting and branding Data Management. This role ensures the efficiency of business operations and creates and implements changes or improvements to process & documentation as needed. The position plans and leads the strategy for process simplification and harmonization, ensuring communication across stakeholders and end users. The AD, Process & Documentation for Data Management provides functional process expertise, working closely with Subject Matter Experts within and beyond the functions. This role is responsible for promoting and communicating activities in DM to stakeholders across the business and externally. It serves as the expert in Clinical Data Management Process development, providing oversight and advice to SMEs regarding the development and maintenance of CDM Governing documentation. The position monitors regulatory, technical, and pharma-industry trends to implement continuous process improvements. This role is responsible for a key component supporting Business Operations within Data Management and will collaborate with other Associate Directors to strengthen the function's infrastructure.

Requirements

• Bachelor's degree in a 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 a 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 distill 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 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.
• 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 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 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.
• Leads, facilitates, and supports work in the ECMS 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.
• 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 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 and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director