AstraZenecaR&DClinical Site Lead (BioPharma), Site Management & Monitoring Group, BioPharma Clinical Operations, Development Operations
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Monthly Salary:
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
職務内容 / Job Description
Clinical Site Lead (CSL) is a field-based role within Site Management & Monitoring (SMM) at AstraZeneca K.K. dedicated to supporting clinical trials within Japan. The CSL will be assigned to dedicated disease area and proactively drive site performance enhance site engagement and foster strong relationships with investigators and site staff based on enhancing knowledge at the specific disease area. The CSL will focus on driving recruitment performance and ensuring strong CRO oversight without direct site management and monitoring responsibilities. This role will contribute to operational feasibility assessments and provide input on recruitment and retention strategies as well.
Key Responsibilities
Planning: Contribute to the accurate site and recruitment plan
Partnerships: Establish strategic partnership models and frameworks for deployment across key clinical sites and investigators.
Communication: Maintain awareness of market activities policies trends technologies and information affecting the business to support the ongoing improvement of clinical recruitment efforts in line with company policies
Strategic Input: Provide SMM input to clinical study documents including Clinical Study Protocol (CSP) Informed Consent Form (ICF) and Monitoring Plan.
Performance Monitoring: Monitor study progress including country start-up site activation and recruitment
Risk Management: Track study performance and delivery risks and work alongside LST and GST to develop and implement mitigation plans.
When the CSL is assigned to induvial clinical study having full responsibility for the site and study management from AZ KK the CSL will take following responsibilities.
Lead and manage all activities related to site management and monitoring including the following with agreed timelines and company standard quality in Japan.
Plan and deliver a site selection strategy
Plan patient recruitment strategy including SMO managements and following patient recruitment progress
Lead and manage CRAs including CRO CRAs to deliver clinical study data
Develop and manage risk mitigation plans and contingency plans to execute site managements and monitoring from site qualification to site close on time.
Lead and manage the quality of clinical study data.
Lead and manage queries and quality issues related to site management and monitoring together with CRAs.
Contribute to regulatory inspection in the area of site management and monitoring from study set up through conduct and inspection readiness.
Escalate issues related to site management and monitoring to an appropriate person and contribute to resolve.
Lead certain number of CRAs (incl. CRO CRAs) to in terms of information management and communication related to site management in study team to keep monitoring quality.
Contribute to the development of Development Operations Japan by joining some projects or initiatives e.g. Process Ownership responsibilities CRA training.
Contribute or encourage to innovate clinical trial environment with new technologies which AZ will implement cooperating with study sites and sites staff.
応募資格経験資格等/ Qualification (Experience & Skill etc.)
経験 / Experience
必須 / Mandatory
At least 3-years experience in pharmaceutical industries or clinical research organization preferably in Clinical Operations (CRA Senior CRA)
Demonstrated leadership capability in a team environment successfully.
Negotiated some complicated issues and/or requirements with site staff.
Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
歓迎 / Nice to have
Preferred experience to collaborate with external partners.
Performed monitoring activities from qualification visit to closure visit as a CRA.
Education
必須 / Mandatory
Bachelors degree in a related discipline preferably in life science or equivalent qualification
能力 / Skill-set
必須 / Mandatory
Personal Effectiveness & Drives Accountability in Others
Learning Agility
Financial Technology & Process Competency
Communication & Teamwork Influencing Collaboration Business Partnering
Effective risk-based thinking Strategic thinking Problem Solving Critical Thinking Decision Making
Deliver Priorities Results & Impact Project Management Recruitment/Retention Planning & Action
Act with Integrity & high ethical standards
キャリアレベル / Career Level
D
勤務地 / Work Location
Osaka or Tokyo
Date Posted
01-12月-2025Closing 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.
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
