Associate Director Project Data Manager

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, (i.e. 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:

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

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 AZCHumanResources@astrazeneca.com.

Date Posted

Closing Date

AstraZeneca 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.