Associate Director, Process & Documentation

The AD, Process & Documentation for Data Management (DM) plays a key role in promoting and branding Data Management. Ensures the efficiency of business operations and creates and implements 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 AD, 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

Qualifications

• Bachelor in scientific discipline, or related field with a strong understanding of biomedical data and analytics. Advanced degree is a plus

• 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 Key stakeholders and relationships

The annual base pay for this position ranges from $143,112.80 - $214,669.20 . Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.