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Associate Director Study Management

Location Shanghai, Shanghai Municipality, China Job ID R-089726 Date posted 25/02/2021

Major Responsibilities
•    Leadership of group work and building the team spirit, including developing team style and behavior
•    Organize and chair the monthly project review meeting in SMM China
•    Organize and chair the regular PM forum in SMM China
•    Ensuring adequate  resources for the studies assigned
•    Ensure that the workload of the team(s) or direct reports is adequate
•    Development and performance management of the team(s) or direct reports
•    Ensure that the everyone in the team or direct reports have development and training plans, according to IDP process
•    Contribute to high quality feasibility work 
•    Contribute to efficient SMM organization and its functioning at country level by working closely with responsible SMM Director.
•    Contribute to the quality improvement of the study processes and other procedures.
•    Plan and organize coaching of the team members and all direct reports
•    Ensure that the individual performance planning and review process is completed for all direct reports
•    Prepare salary and bonus proposals of all team members or direct reports  based on their performance in close collaboration with responsible SMM Director and HR partner.
•    Ensure all systems are continuously updated.
•    Assist SMM Director or Local Study Leader/teams  in forecasting study timelines, resources, recruitment, study materials and drugs.
•    Provide direction to LSL/teams on major study commitments including resolving any key issues identified.
•    Review of monitoring reports/follow up letters of all direct reports as per study monitoring and/or local QC plans.
•    Perform necessary accompanied site visits for direct reports, supporting ongoing coaching and development.
•    Support SMM region in initiatives/activities as agreed with SMM Director(s).

Minimum Requirements and Preferred Background

  • •    University degree in biological science or healthcare-related field, or equivalent. 
    •    Minimum 10 years experience in Clinical Operations (CRA / Sr. CRA / LSTL/CRM) or other related fields. 
    •    Proven team building and people/organizational development skills.
    •    Excellent knowledge of spoken and written English. 
    •    Good ability to learn and to adapt to work with IT systems.

    Functional skills
    •    Very good knowledge of the Clinical Study Process, AZ Procedural Documents and international ICH/GCP guidelines.
    •    Excellent knowledge of the Monitoring Process.
    •    Good understanding of the Study Drug Handling Process and the Data Management Process.  
    •    Good knowledge of relevant local regulations.
    •    Good medical knowledge in relevant AZ Therapeutic Areas.
    •    Good knowledge of the Drug Development Process.
    •    Ability to deliver quality according to the requested standards.
    •    Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
    •    Have a rich of CRO management experience and skills
    •    Have the strong communication skills among x-functional stakeholders .

    Management Skills
    •    Ability to work in an environment of remote collaborators.
    •    Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business. 
    •    Integrity and high ethical standards.
    •    Excellent resource management skills.
    •    Excellent decision-making skills.
    •    Good financial management skills.
    •    Good delegation skills.
    •    Good conflict management skills.
    •    Good interviewing skills – responsibility for attracting, developing and retaining personnel.
    •    Good in handling crisis situations.
    •    Excellent team building skills also in cross-functional teams. 
    •    Excellent interpersonal skills.
    •    Good intercultural awareness.
    •    Excellent organizational skills.
    •    Excellent analytical skills.
    •    Excellent influencing skills. 
    •    Excellent negotiation skills. 
    •    Excellent communication skills, verbal and written.
    •    Excellent ability to prioritize and handle multiple tasks.
    •    Excellent ability to have attention to details.
    •    Excellent ability in working according to global standards.

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 authorisation and employment eligibility verification requirements.

10000929 F CDSM R&D Oncology (Susan Galbraith (07016555)) (85008610)

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.