Responsible for the oversight of the Clinical Data Management (CDM) delivery of high-quality data via external partners or internally run studies for one or more assigned projects or an indication.
Alternatively, acts as an expert on Clinical Data Management (CDM) projects and technology outside of CDM program support.
Maintains an up-to-date awareness of trends / changes in external CDM approaches and serves as a subject matter expert in process development and improvement.
May act as a team leader or provide training or coaching to junior colleagues within CDM.
Provides CDM leadership for assigned projects, indications and / or studies dependent on size and scale of the project.
Takes global accountability and serves as the second line of contact at the project level.
Demonstrates leadership and operational expertise in the strategic planning and delivery of CDM deliverables at project level.
Management and oversight of vendor contracts, resourcing and budget management and oversight of vendor performance for assigned projects and studies.
- Communicates and negotiates effectively with all other project level team members. Primary point of contact for Clinical Data Management (CDM) at the Global Program Team (GPT) level.
- Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent CDM processes and documentation across assigned projects, ( ensuring consistency across data quality plans.)
- Provide oversight and expertise of external service providers or in-house teams to deliver quality data with compliance to study model procedures and standards;
give guidance on AZ standards, processes, systems and expectations to external partners, internal partners and third-party vendors.
- Responsible for proactive risk management and issue resolution / escalation connected to Clinical Data Management improvement or technology.
- Proactively provides suggestions to improve AZ Standards, CDM processes and technologies. May also act as a Subject Matter Expert in any of these areas.
- Develops an understanding of CDASH and SDTM or other recognized industry standards and impact to programming team to ensure consistency of program level standards.
- Specialist in TA specific data capture and standards, conducts lessons learned and disseminate across the organization as appropriate
- Provides data management expertise in supporting strategic and operational aspects of Data Management on project level.
- May act as a team leader or mentor Clinical Data Management colleagues and any stakeholder with operational processes used in studies and projects.
- Represents Clinical Data Management at cross functional forums, meetings and provides timely feedback to partners.
- Understands health authority requirements and provide input into the Clinical Data Management related activities associated with regulatory inspections / audits and liaison with Clinical Quality Assurance.
May also assist with AZ QIs.
Demonstrates willingness to take on and lead any project level activity consistent with current or experience in support of study delivery.
May also act as Study Data Manager for assigned studies.
Performs any CDM related ad-hoc requests from Line Manager. Support Line Manager with portfolio oversight.
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
30-May-2024
Closing Date
01-Jul-2024
Associate Project Manager M&A Advisory
Experience in performing energy assessments and/or analyzing output data for renewable energy projects, such as:Validation of technical inputs in project financial models including estimation and review of construction and operating costs, and energy estimates;Operational evaluations through Monthly...
Sr. Manager/ Associate Director- Credit Risk Manager / Credit Risk Strategy
Gathers and analyzes macro-economic data, competitive benchmarking data and determines impacts to ongoing portfolio performance and recommend credit strategy changes as appropriate. We are the trusted analytics partner for several Fortune 100 companies, enabling them to generate business value from ...
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. Extensive pharmaceutical industry/CRO experience within clinical study/research project delivery, drug development process and relevant g...
Senior Project Manager
Botsford Associates is expanding its Risk Management practice and in doing so we are in search of an experienced Senior Project Manager to join our xVA team. In this role you will lead a project tied to a new strategic xVA system used for running stress testing calculations for various products. In ...
Senior Project Manager - Wastewater Services **MARKHAM, ON**
Serving as Project Manager on major water and wastewater projects in the GTA and other municipalities in Ontario, acting as primary contact with the client project manager, and being responsible for project scope, schedule, budget and quality management, as well as management of multi-disciplinary d...
Associate Project Manager - (Technology / Payments / Banking)
Ensures that a successful business outcome is the prime measure of project success including delivering projects on time, within budget, within quality standards and to the satisfaction of the project sponsor. Provides guidance to the project sponsor on the implementation and sustainment of projects...
RQ08064:Digital & Data Project Manager
The Project Manager is expected to strategize, lead, plan and report on the development and implementation of the Digital and Data Action Plan in partnership with the Digital & Analytics Strategy Division. The Project Manager will implement processes and practices facilitating portfolio manageme...
Senior Project Manager, Transportation
Planning projects, developing accurate scopes of work, cost estimates, project plans, schedules and deliverables to execute high quality projects on time and on budget. Senior Project Manager, Transportation. RVA is looking for a Senior Project Manager to join their Transportation team in a full-tim...
Associate Director, Project Management - Live MedComms Events
Associate Director, Project Manager – Position Summary:. 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 ...
Senior Project Manager, Municipal - Niagara
Project manage and/or technically support the design team and oversee projects / project performance. Senior Project Manager, Municipal - Niagara. Ensure projects meet the professional needs of RVA and Quality standards and participate in interdisciplinary review of project deliverables. Whatever yo...