Project Manager, ESR Governance Operations

About the role

As Project Manager,ESR Governance Operationswithin the Oncology Business Unit MedicalInnovation, Strategy, and OperationsTeam at AZ, you will play a pivotal role in channelling our scientific capabilities to make a positive impact on changing practice and patients’ lives. You will support evidence generating activities according to specific processes to help secure Oncology portfolio deliverables to time, cost, and quality.This role will report directly to the Senior Director, Project Management Office and be based in Mississauga, Canada.

Accountabilities/responsibilities

• Deliver comprehensive end-to-end project management leadership to the Externally Sponsored Research governance process and portfolio, serving as a subject matter expert and a single point of contact for stakeholders, queries, and tools/systems, while championing high quality and SOP compliance.

• Manage and update all ESR statuses and decisions in the ESR Management System and any related documentation, from the initial proposal submission through to the approval of protocols and amendments.

• Independently deliver and address complex activities or customer queries; manage multi-layered global to local market stakeholder maps using solid professional judgment and decision-making.

• Provide strategic guidance and input into the development and implementation of Global Medical Affairs study governance processes, driving standardization and consistency across teams for intake, routing, record-keeping, tracking, communication follow-up, and issue resolution.

• Collaborate with Local and Global teams to triage proposals to appropriate teams and against strategy, ensure appropriate risk classificationis assigned, and prepare presenters for the Global Review Committee (GRC) meetings.

• Ensure successful execution of the GRC meetings and their outcomes, including preparation and dissemination of materials, agenda setting, meeting facilitation, minute-taking, and follow up with review committee members for all necessary actions in a timely manner.

• For protocol and amendments reviews, serve as single POC to liaise with external vendor and route to the necessary local, global, and functional reviewers, ensuring all relevant documents are accessible to reviewers and providing prompt support upon request.

• Update ESR Strategies and Areas of Interest on internal and external websites in collaboration with Corporate Communications & Compliance.

• Support one or more tumor areas and/or business units in all initiatives.

• Identify process gaps and propose solutions, driving process simplification, clarity, and improvements; provide expertise in process, tools, and systems.

Culture

• Foster an entrepreneurial and externally oriented team focus that emphasizes courageous leadership, strategic collaboration, and innovation.

• Collaborate strongly with other Project Leaders to incorporate best practices.

• Encourage a flexible mindset dedicated to achieving efficient productivity.

Required experience

• Bachelor’s degree in biological science or healthcare-related field

• At least 2 years working experience in healthcare, clinical sites, or related industry roles

• Experience of effective working in a multi-cultural, matrixed environment

• Experience working in a global setting, managing stakeholders within different time zones

• Excellent written and verbal communication skills as well as proven collaboration, organizational, and problem-solving/critical thinking skills 

• Excellent knowledge of spoken and written English 

• Team oriented and flexible; ability to respond quickly to shifting demands and opportunities 

• Strong interpersonal skills and ability to work in a team environment 

• Demonstrate concern of standards, concern of impact, good team skills including cooperation, willingness to learn from others, sharing relevant information, adaptability, self-control and tenacity 

• Willingness and ability to train others when needed

• Demonstrate ability to work independently, as well as in a team environment 

• Experience using systems and tools

Preferred Requirements

• Master’s degree in biological science or healthcare-related field

• Knowledge of the clinical study and drug development processes, GCP/ICH guidelines and general understanding of the development/commercialisation of pharmaceutical products

• Six Sigma Medical/Process Excellence and/or Project Management/PMP/FPX certification is a plus but not required

• Depth of understanding of medical, scientific and/or commercial pharmaceutical marketplace of Oncology

Knowledge/Skills/Competencies

• Skilled in process development and implementation, organizational effectiveness, and communication

• Able to deliver high quality work outputs despite ambiguity or a constantly evolving environment

• Delivery focus with an ability to be responsible for and manage multiple project deliverables in very short timelines

• Strong interpersonal skills with an ability to flex styles dependent upon the situation

• Ability to pull together diverse teams over whom they have no line management responsibility in a matrix environment (i.e. ability to influence and drive for results)

• An excellent communicator; evidence of strong independence and innovative seeker of strategic solutions; forward looking