• Be responsible for the on time, quality, within budget delivery of global and local medical affairs clinical study and program for key products

•  Prepare and deliver study level feasibility, and develop recruitment strategies , and the delivery of the approved Clinical Study Protocol .The job holder will lead a team to develop and deliver study results and ensure study meet local, regional and globally agreed timelines.

•  Responsible for the delivery of clinical study to time, quality and budget in compliance with GCP/SOPs, local regulations and the Clinical Study Protocol

•  Monthly track and manage to agreed project timelines, budget and resource to highlight significant variance and take appropriate actions to get project on track.

•  Review and approve project relevant document.

•  Timely update projects information to the Brand Team

•  Lead preparation and delivery of study documents (e.g. Protocols/amendments, ICF, CRF, study related forms, etc.)

•  Prepare and lead investigator and monitor meeting

•  Ensure SAE reporting according to GCP and regulation

•  Plan and lead activities associated with study level Quality Control plan

•  Develop & manage contingency risk plans to assure timely delivery to quality, budget, and time and escalate issues to stakeholders as appropriate

•  Provide operational support to the ESR investigators to ensure the on time delivery of ESR

•  Update study information into IMPACT,ESR

• and/or global & regional team to ensure up-to-date information captured

• Clinical study and program progress on track

• Actual vs. Plan on budget, timeline of clinical study and program

• Timely update in IMPACT, ESR /global & regional team

• No critical audit findings for post-marketing clinical program

• Feedback from line manager, direct reports and Brand Team members

• Optimize existing local process/working instruction on clinical study and program

•  Provide input to local process on clinical study and program

•  Share best practice within team

•  Feedback from line manager and direct reports.

• Develop KOL through the clinical study and program

•  Work with Brand Team on KOL/potential investigators development activities including appropriate investigators and sites selection, operational experience improvement through projects delivery in big city big hospital.

•  Investigator’s future engagement in AZ study

•  Feedback from internal/external customers

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.