Associate Director, Process & Documentation Business Planning & Operations, Data Management

Job title:

Associate Director, Process & Documentation Business Planning & Operations, Data Management

Company

AstraZeneca

Job description

WHY JOIN US?
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.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.AccountabilitiesBusiness Planning and Operations (BPO) within the Clinical Programming domain, part of the Data Management (DM) teamAccountable 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 complianceDevelops strategies for effectively communicating process changes internally and externallyServes as a functional process expert with a focus on clinical programmingBrings a six sigma approach to processes to ensure best practices are upheldEvaluates and improves business processes, brainstorming and collaborating with teams for new ideasMonitors and assesses processes to ensure desired outcomes in close collaboration with Business Process ManagementLiaises with counterparts in Process and Enablement to ensure company SOPs are updated as necessaryDevelops high-quality, informative communications that brand DMEnsures all messaging aligns with key business strategiesDevelops content for social media, newsletters, town halls, and other distribution channelsProduces videos detailing who we are and what we doDevelops reports showcasing activities in Data ManagementCreates questionnaires to gather feedback from stakeholders and baseline businessCollaborates closely with cross-functional colleagues to ensure connectivity and dependencies of DM processes on other functional processes are consideredLeads, facilitates, supports work in the ECMS toolActs as SOP steward and trainer with functional SME supportManages and coordinates resource assignments for review cycles of governing documentationRepresents DM as SME during activities associated with LSI governing documentation system (AZDoc & AZLearn)Partners with LSI colleagues to ensure appropriate training curriculum for DM staffTranslates business objectives into individual assignments/tasksCollaborates with Biometrics, Data Management, Clinical Operations, and partner CRO organizations to ensure coordination, compliance, and proper use of DM ProcessesLeads creation of workstreams for developing new CDM governing documentationProvides oversight and advice on creating SOPs, Guidelines, Job Aids, supporting templates, and formsOffers expertise and consultancy to TA Leads on interpreting CDM governing documentationEssential Skills/ExperienceBachelor in scientific discipline or related field with a strong understanding of biomedical data and analytics. Advanced degree is a plusRelevant experience in a pharmaceutical, biotech, CRO or Regulatory AgencyExperience in Clinical Programming (SAS)Experience as a project manager and subject matter expert of special initiatives supporting DM activitiesAbility to work independently under pressure meeting tight deadlines, demonstrating high level of initiative and flexibilityExcellent organizational and analytical skillsStrong technical and problem-solving skills with experience of computer systems for Data ManagementExcellent understanding of clinical trial methodology, GCP, ICH, GCDMP, and medical terminologyExperience with technologies and best practices across multiple platformsDemonstrated experience supporting complex projects and cross-functional teams including delivering to project and portfolio metricsExcellent communication, interpersonal, and negotiating skills relating to colleagues and associates internal/external to the organizationStrong track record of building successful relations with supervisors, peers, suppliers, customers, partners, and stakeholders is essentialStrong strategic experience and business analytics ability to distill research needs and define business, technical, and operational requirementsStrong team playerDesirable Skills/ExperienceAbility to multitask and monitor several activities on a daily basisSix Sigma green belt certifiedAbility to coach and mentorAbility to take initiative to develop new strategies and outside-the-box ideas for social mediaExcellent media relations skillsSO, 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.Great People want to Work with us! Find out why:Are you interested in working at AZ, apply today!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 .#LI-HybridDate Posted 13-Dec-2024Closing Date 12-Jan-2025AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Expected salary

Location

Mississauga, ON

Job date

Sun, 15 Dec 2024 04:45:07 GMT

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