Description
of Services)
Co-ordinate / lead timely contributions of AZ core / extended members
Collaborate with key partners cross-functionally, and / or external partners, to identify, handle and resolve issues affecting study delivery
Review protocol drafts and input operational perspectives / content into document and authoring team discussions
Provide input into and / or quality review and hold accountability for the development of crucial study level documents ( ICF, study plans and guidelines), delegate responsibilities among the team as appropriate
Ensure all required External Service Providers ( CROs) are engaged at the study level (including execution of relevant vendors contracts) and are performing to contracted goals, timelines and budget, as well as adequate oversight is documented
Responsible for study budget management through the study lifecycle and for providing budget progress updates to Dir EPM / Sr Dir EPM including any financial risks and mitigation plans (as part of the ongoing study change control process)
Maintain / report accurate cost forecasts throughout study, lead study spend within available budget & agreed tolerances
Lead / be responsible for financial processes (PO's, invoicing, cost reconciliation etc.), may delegate as appropriate
Responsible for setup of the study cost tracker
Monitor study risks throughout delivery and oversee team in the development / implementation of mitigations and contingencies
Oversee study / EAP level performance against agreed upon plans, achievements and key performance metrics, EAP exit strategy
Identify and report quality issues that have occurred within the study, proactively communicate findings and corrective action plans (CAPA) to relevant collaborators
Supervise periodic TMF QC and responsible for review of relevant sections / documents in accordance with SOP / Wiki
Specifically in the EAP space if assigned to, in addition to the above :
Lead program planning, set up, implementation and delivery of EAP in collaboration with local / regional / global medical and market access teams
Participate in operational governance activities related to agreed CRO strategic and operational governance principles
Perform vendor oversight to ensure EAP delivery to time, cost and quality
Collaborate with vendors to ensure the EAP operational aspects are effectively undertaken and that they have clear remits for delivery
Manage resolution of program specific issues and partner concerns with internal and external team members
Requirements : Essential :
Essential :
Bachelor’s degree required preferably in medical or biological science or equivalent by experience
Extensive pharmaceutical industry / CRO experience within clinical study / research project delivery, drug development process and relevant guidelines, for example GCP / ICH, for a specific therapeutic and geographical area
Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools
Ability to effectively work with Clinical Research Organisations / External Providers
Ability to mentor, develop and educate staff
Leadership promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives
Ability to look for and champion more efficient and effective methods / processes of delivering evidence studies focusing on key performance metrics around reliability, efficiency, cost and quality
Consistent record in interacting widely and effectively within the company across regions, functions and cultures
Persuasive communicator in English with a proven track record to work collaboratively in a multi-cultural environment
Desirable :
Experience and knowledge within compliance management of Early Access Program
Advanced degree in medical or biological sciences or field associated with clinical research
Experience of incorporating digital health and patent centric strategies into clinical studies
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 .
Date Posted
17-Jun-2024
Closing Date
30-Jun-2024
Associate Director, Evidence Project Management
Project Management qualification or demonstration of project management skills including scope, budget, timeline, resource management and use of associated tools. Responsible for study budget management through the study lifecycle and for providing budget progress updates to Dir EPM /Sr Dir EPM incl...
Associate Director, Project Management
The Associate Director, Project Management position will work across all functions and departments to manage deliverables required to implement and maintain Teladoc Health Canada’s line of business. Manage key project risks and issues, including appropriate escalation to executive sponsors as needed...
Associate Director, Project Management - Live MedComms Events
A leading Canadian medical communications agency is looking for an Associate Director, Project Management to join the team – someone based ideally in Ontario and with 7-8+ years of experience. Provide project management to the team throughout the project life cycle utilizing company and client syste...
Associate Director, Regulatory, Governance & Issues Management
As part of the Group Risk Management team (GRM), the Associate Director, Regulatory, Governance & Issues Management will act as a central point to achieve common outputs for ORSS and GRM OR driven by work orders. Experience in project management. Business Process Design, Decision Making, Financial R...
Associate Director, Prospect Management
Under general direction, the Associate Director, Prospect Management contributes to the successful development of a stronger pipeline for the University of Toronto’s fundraising priorities and the institutional campaign and the success of yearly strategy initiatives and planning to mitigate delays. ...
Real World Evidence Associate Director
AstraZeneca has a pedigree of experience in Real World Evidence, having developed a coherent strategy to develop and internalize rich data assets the group is now amplifying those investments through a Real World Evidence Data Science capability. Powered to take sensible risks based on scientific ev...
Credit Analyst, Associate Director / Director - Funds & Asset Management - Toronto
Fitch Ratings’ Funds & Asset Management group is currently seeking an Analyst, Senior Analyst or Associate Director based out of our Toronto office. Fitch Ratings’ Funds & Asset Management group is a global team responsible for fund ratings analysis, methodology and model development, and publicatio...
Associate Director Project Data Manager
Management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned projects and studies. Provides data management expertise in supporting strategic and operational aspects of Data Management on project level. Responsible for the oversight ...
Director of Program Management Office and Project Controls
MBA or bachelor’s degree in construction management, business administration, project management (or PMP), engineering or a related field. Within our consult business we harness our unique combination of leading-edge practical expertise and project delivery consultancy to unlock the potential in eve...
Director/Associate Director, Asia Asset Liability Management
Description – Director/Associate Director , Asia Asset Liability Management. The Global Asset Liability Management group plays a leadership role in the identification and assessment of ALM related risks globally, along with the development of investment and risk management strategies to support the ...