【AstraZeneca】【R&D】Senior Clinical Research Associate / Clinical Research Associate (Oncology), Development Operations, Late Development Oncology Clinical Operation 1 job opportunity at AstraZeneca.

Home Jobs In Japan Tag: Development Operations, Late Development Oncology Clinical Operation 1 【AstraZeneca】【R&D】Senior Clinical Research Associate / Clinical Research Associate (Oncology), Development Operations, Late Development Oncology Clinical Operation 1 position at AstraZeneca


DateMore Than 30 Days Ago bot
AstraZeneca 【AstraZeneca】【R&D】Senior Clinical Research Associate / Clinical Research Associate (Oncology), Development Operations, Late Development Oncology Clinical Operation 1
Experience: 3-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Development Operations, Late Development Oncology Clinical Operation 1

Copy Link Report
degreeAssociate
loacation Japan - Osaka, Japan
loacation Japan - Osaka....Japan

■ 職務内容 / Job Description Monitor is responsible to ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and the trial site in order to verify that: ・The rights and well-being of human subjects are protected. ・The reported trial data are accurate, complete, and verifiable from source  documents. ・The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s). ■Key Responsibilities • Acting as the main line of communication between the sponsor and the investigator. • Communicate with Japan Study Leader and third party vendors as needed. • Conduct site selection activities for verifying adequate qualifications. • Manage and monitor the responsible sites and ensure their quality appropriately, agreed cost spent and on a timely basis. •  Ensure input the latest site related information in IMPACT at appropriate timing. •  Participate in-house and/or external clinical trial related meeting (ex. Study team meeting, CRA’s meeting, Investigators’ meeting) including the preparations. •  Cooperate with site audit in liaison with QA and a site inspection by regulatory authority. •  Cooperate with resolving the result of SAE reconciliation. •  Ensure inspection ready TMF regarding site related documents. In addition to above, Senior CRA also is to  •  Lead a 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. •  Taking some tasks delegated by Study Leaders if agreed. •  Contribute to the development of Clinical Operations Japan by joining some projects or initiatives, e.g. Process Ownership responsibilities, CRA training. •  Mentor CRAs on monitoring and internal procedures. ■ 応募資格（経験、資格等）/ Qualification (Experience & Skill etc.) 【経験 / Experience】 ＜必須 / Mandatory＞ •    At least 3 years of CRA experience. •    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＞ •    Bachelor’s degree (or equivalent), preferably in biological science or discipline associated with clinical research 【能力 / Skill-set】 ＜必須 / Mandatory＞ ＜Required for CRA＞ • Communication skill  • Negotiation skill • Spirit of inquiry • Ability to manage for delivering the clinical study data. • Ability to plan effective monitoring activity  • Ability to build and manage effective relationship with Investigators and site staff • Consistently exhibits Leadership capability as below:    Drives Accountability - focuses on delivery/results; holds self accountable: Stretches and challenges self to meet or exceed high standards of behaviour and outcomes in line with AZ Values.    Works Collaboratively - seeks diverse views: shares and seeks out diverse views, incorporating them where appropriate in order to develop better proposals and creative solutions for the business ＜Required for Senior CRA＞ • Communication skill  • Negotiation skill • Spirit of inquiry • Ability to manage for delivering the clinical study data. • Ability to plan effective monitoring activity  • Ability to build and manage effective relationship with Investigators and site staff • Consistently exhibits Leadership capability as below:    ・ Drives Accountability - focuses on delivery/results; holds self accountable: Stretches and challenges self to meet or exceed high standards of behaviour and outcomes in line with AZ Values.    ・ Works Collaboratively - seeks diverse views: shares and seeks out diverse views, incorporating them where appropriate in order to develop better proposals and creative solutions for the business • Demonstrate superior site monitoring and management skills at the site level covering more sites with multiple protocols compared to CRAs.  • Examine issue signals and resolve them with appropriate resolution and timing.  • Effective problem and conflict resolution skills especially for CRA/Site related issues. Collaborate with other function's experts, if needed. • Ability to share best practice and lessons learnt actively to improve quality and productivity of the wider monitoring team. • The ability to build and manage effective relationship with CRO to keep monitoring quality. 【キャリアレベル / Career Level】 D (Seniro CRA) C (CRA) 【勤務地 / Work Location】 Osaka or Tokyo Date Posted 27-1月-2026 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.

Other Ai Matches

【AstraZeneca】【ONC】MR, オンコロジー事業本部 Applicants are expected to have a solid experience in handling オンコロジー事業本部 related tasks
Director Cell Therapy CMC Program Lead - Late Stage Applicants are expected to have a solid experience in handling Job related tasks
MR-GUGY-清远 Applicants are expected to have a solid experience in handling Job related tasks
Regulatory Affairs Director Applicants are expected to have a solid experience in handling Job related tasks
Senior DevOps Engineer (AWS) - Evinova Applicants are expected to have a solid experience in handling Job related tasks
MR-HEMA-南京 Applicants are expected to have a solid experience in handling Job related tasks
Clinical Research Associate (Biopharma) Applicants are expected to have a solid experience in handling Job related tasks
Associate Director Quality Control Applicants are expected to have a solid experience in handling Job related tasks
Senior CloudOps Engineer Applicants are expected to have a solid experience in handling Job related tasks
희귀질환 사업부 신입 영업사원(MR) Applicants are expected to have a solid experience in handling Job related tasks
Oncology Account Specialist (Hematology) – Boston, MA Applicants are expected to have a solid experience in handling MA related tasks
Maintenance Technician - Nights Applicants are expected to have a solid experience in handling Job related tasks
Medical Representative - ONCO - HCM Applicants are expected to have a solid experience in handling Job related tasks
Senior Facility Engineer Applicants are expected to have a solid experience in handling Job related tasks
Key Account Manager for Hybrid Area (Bangkok + Southern), CVRM Applicants are expected to have a solid experience in handling CVRM related tasks
Data Science / AI Intern – Literature Mining & Graph Modeling Applicants are expected to have a solid experience in handling Job related tasks
Senior Director, Clinical Operations Strategic Enablement R&I Applicants are expected to have a solid experience in handling Clinical Operations Strategic Enablement R&I related tasks
Assistant de Direction (H/F) Applicants are expected to have a solid experience in handling Job related tasks
Medical Science Liaison-HTN-Guangzhou Applicants are expected to have a solid experience in handling Job related tasks
Medical Scientific Liaison - CVRM Applicants are expected to have a solid experience in handling Job related tasks
Credit Collection and Treasury Administrator Applicants are expected to have a solid experience in handling Job related tasks
Senior Data Engineer - Data Pipelines Applicants are expected to have a solid experience in handling Job related tasks
Financial Analyst - Cairo Applicants are expected to have a solid experience in handling Job related tasks