Typical Accountabilities

·Lead, guide, evaluate and develop the team, to ensure the quality execution and delivery of the site monitoring in the determinate sites. Build up the team spirit and contribute to efficient SMM organization by working closely with SMM Director.

·Ensuring adequate site monitoring resources allocation for the studies assigned and manage resource conflicts.

·Accountable for build and retain an efficient CRA team by providing leadership and monitoring to CRA.

·Develop CRA's professional capability, be accountable for CRA's career development according to business needs and individual aspiration. Providing necessary career development suggestions and co-design the individual development plans and implement the plans.

·Contribute to the quality improvement of the study processes and other procedures. Oversee relevant system which maintained by CRA with high quality. Review of monitoring reports/follow up letters of CRA as per study monitoring and/or local clinical quality management plans. Perform necessary accompanied site visits for CRA.

·Assist SMM Director or Local Study Manager/teams in forecasting study timelines, resources, recruitment, study materials and drugs. Provide guidance to Local Study Manager/teams on major study commitments including resolving any key issues identified.

·Contributes to development of clinical investigator network and strategic cooperation with sites to support clinical trial execution.

·Ensure CRA complying with company policy and code of conduct.

Education, Qualifications, Skills and Experience

Essential

·Bachelor degree in biological science or healthcarerelated field, or equivalent.

·Minimum 5 year experience in Clinical Operations (CRA/CSM).

·People coaching or mentoring experience is preferable.

·Solid knowledge of the Drug Development Process,Clinical Study Process, AZ Procedural Documents and

international ICH/GCP guidelines, relevant local regulations.

·Excellent knowledge of the site management and monitoring.

·Fluent in both oral and written English.

·Good learning agility.

·Good ability to learn and to adapt to work with IT systems.

Desirable

·Good understanding of the Study Drug Handling Process and the Data Management Process.

·Ability to work in an environment of remote collaborators.

·Ability to Manage change with a positive approach for self and team.

·Ability to prioritise and handle multiple tasks.

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.