Associate Director, Process & Documentation

The Associate Director, Process & Documentation for Data Management plays a key role in promoting and branding Data Management. Ensuring the efficiency of business operations and creating and implementing changes or improvements to process & documentation, as needed.

Plans and leads the strategy for process simplification and harmonization and ensures this is communicated across stakeholders and end users. The Associate Director, Process & Documentation for Data Management plays a key role in providing functional process expertise, working closely with Subject Matter Experts within the functions and beyond, where required.

Responsible for promoting and communicating activities in DM to stakeholders across the business and externally. Serves as the expert in Clinical Data Management Process development to provide oversight and advice to the SMEs regarding the CDM Governing documentation development and maintenance.

Monitor regulatory, technical and pharma-industry trends to implement continuous process improvements. This position is responsible for one of the key components that supports Business Operations within Data Management and will collaborate with the other Associate Directors to strengthen the infrastructure of the function.

Accountabilities:

• 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.