KPS Life is seeking a Sr. Clinical Trial Manager based in Japan. Contact Nikhil Nair to discuss this opportunity further: [email protected]
The Senior Clinical Trial Manager (SrCTM) is responsible for study team leadership in one or more cross functional study teams to deliver clinical research study deliverables on time, within budget and with good quality in compliance with Regulatory Authorities' regulations/ICH GCP guidelines and applicable SOPs. This role collaborates and interacts with the Clinical Study Team and oversees the functional duties of the study and CRA team.
The SrCTM will:
- be responsible for the oversight of the execution and adherence of various aspects of the study operational plan (start up, conduct, close-out, and vendor oversight) with input from key stakeholders including adherence to all relevant regulations including GCP, ICH and Regulatory requirements, as well as applicable SOPs and policies.
- be responsible for the oversight of monitoring assigned study operational plan.
- be responsible for managing assigned as study budget, timelines, and risk mitigation
- process input from key stakeholders, communicating to the clinical team, as appropriate.
- support the development and application of standardized operational study processes, methodologies, appropriate quality and performance metrics and tools to systematize continuous process improvement and impart best practices across clinical operations to maximize its effectiveness.
- be responsible for the filings of all clinical trial documentation in eTMF and paper TMF as assigned.
The SrCTM will have:
- in-depth knowledge of clinical drug development processes and experience applying GCP, ICH and FDA requirements.
- solid knowledge of clinical research study protocol and processes; ability to incorporate and adhere to GCP and regulatory standards. Ability to develop study processes in support of a clinical study design.
- demonstrated solid knowledge in several areas related to clinical research: human anatomy, subject protection, regulatory requirements, study design, study execution.
- demonstrated skills in implementing tools for effective study management, identifying and implementing solutions to address study issues, overcoming obstacles.
- demonstrated skills in cultivating relationships with healthcare professionals and cross-functionally with co-workers from both the Sponsor and KPS teams
- demonstrated skills in maintaining composure and identifying and adapting to shifting priorities and competing demands
- Excellent written and verbal communication.
- The ability to generate concise summaries for different audiences, professional correspondence, presentations, reports, and training materials.
- Literacy in word processing, spreadsheets, and databases applications (e.g., MS Word and Excel).
- Skilled at developing project timelines and milestones and working with team to ensure milestones are met; adjusts appropriately when needed and communicates risks when necessary.
- strong communication skills to be able to discuss with the Principal and Sub-Investigators and their site staff, even in challenging situations such as recruitment, protocol deviations and oversight.
- Ability to identify and articulate risks and benefits of plan.
- High attention to detail and accuracy; ability to ensure data accuracy and review data.
The SrCTM will have:
- BS degree in biology, allied health, nursing or related life science preferred.
- 7 or more years related experience in clinical study execution.
- experience leading a study or significant participation on study team through major milestones.
- experience in planning study design for pre and/or post market trials.
- experience managing others as direct supervisor and/or leader of matrix clinical trial team preferred.
- experience managing CROs and other external providers.
- system experience preferred: (i.e., CTMS, eDC, eTMF etc.).
-
Sr. CTM Japan
2週間前
Japan KPS Life ￥5,000,000 - ￥15,000,000 per yearKPS Life seeks a Senior Clinical Trial Manager based in Japan to lead study teams and deliver clinical research study deliverables on time and within budget. · Oversight of study operational plan execution and adherence to regulations. · Monitoring assigned studies. · Managing st ...
-
Sr. Recruiter Japan
2ヶ月前
Chiyoda Palo Alto Networks Full time￥4,320,000 - ￥6,480,000 per yearPalo Alto Networks is in search of a Senior Recruiter to evolve our recruitment model, process and strategy for Go-To-Market teams in Japan. This position encompasses all stages of the hiring process – from partnering with business leaders on position strategy and candidate requi ...
-
Chiyoda, Japan Palo Alto Networks ￥5,400,000 - ￥10,800,000 per yearPalo Alto Networks is in search of a Senior Recruiter to evolve our recruitment model, process and strategy for Go-To-Market teams in Japan. · ...
-
Sr. Recruiter Japan
2ヶ月前
Chiyoda Palo Alto Networks ￥4,500,000 - ￥6,300,000 per yearPalo Alto Networks is in search of a Senior Recruiter to evolve our recruitment model, process and strategy for Go-To-Market teams in Japan. · Partner with business leaders on position strategy and candidate requirements · Develop sourcing strategies to target and assess top tale ...
-
Tokyo Elanco Full time$100,000 - $200,000 per yearAs an HR Business Partner at Elanco Japan, you will provide HR partnership to the organization including contributing to business strategy and developing people plans/initiatives. You will also ensure compliance with local labor laws and foster a high-performance culture. · ...
-
Tokyo Elanco ￥450,000 - ￥750,000 per yearWe are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. · Making animals' lives better makes life better – join our team today · ...
-
Tokyo Intuitive ￥800,000 - ￥1,600,000 per yearWe are seeking an experienced Senior Manager of Commercial Operations for Japan. Reporting to the Director of Commercial Operations, Asia, this role will be responsible for driving sales alignment, commercial excellence, and organizational capability across Japan and APAC's direc ...
-
JP - Tokyo Elanco ￥560,000 - ￥1,200,000 per yearThis role will serve as an HR Business Partner to provide HR partnership to Elanco Japan organization including contributing to business strategy, developing and executing an aligned people strategy; designing and catalyzing implementation of relative people plans/initiatives; an ...
-
Tokyo Elanco ￥80,000 - ￥160,000 per yearWe are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. We believe that diversity is the driving force behind innovation, creativity, and overall business success. · ...
-
Japan, Tokyo Workday ￥5,000,000 - ￥10,000,000 per yearWe are looking for a Sr. Services Executive to join our team in Japan. As a Workday Global Services Organization's Services Executive, you will be responsible for planning, management, and execution of all Professional Services business development activities in your area. · You' ...
-
Tokyo L'Oréal ￥8,000,000 - ￥12,000,000 per yearTAKAMI Sr. CRM Planner responsible for maximizing sales and customer experience in D2C business, collaborating with various teams to lead strategic planning, execution, and analysis. · Key Job Accountabilities include promoting projects, managing marketing campaigns, analyzing da ...
-
Tokyo Tesla ￥5,000,000 - ￥10,000,000 per yearTesla has an opening for a Construction Project Manager to lead the construction of new Sales, Service, and Delivery sites as we expand our fleet throughout Japan. · Receive, review, and ascertain the real estate handoff of each project to establish a project budget and schedule ...
-
Shinjuku Cordis Full time￥3,600,000 - ￥6,000,000 per yearProvide support on a range of medical device and activities which include product submissions, implement regulatory strategies, change assessments, commercial supports, and other responsibilities aligned with medical device regulation and business goals. · Implement regulatory st ...
-
Tokyo Visa ￥8,000,000 - ￥12,000,000 per yearMake an impact with a purpose-driven industry leader. Join us today and experience Life at Visa. · Act as a primary point of contact for providing day-to-day operational support to clients. · Establishes and fosters relationships with clients and internal stakeholders at all leve ...
-
Tokyo Visa Full time￥8,000,000 - ￥15,000,000 per yearAs a Senior Consultant supporting Japan market, you will be leading Client Services operational and processing engagements as well as supporting Value-Added Services activities. You will be responsible for providing day-to-day operational support to clients, establishing and fost ...
-
Tokyo SpaceX ￥8,000,000 - ￥12,000,000 per yearSpaceX is leveraging our experience in building rockets and spacecraft to deploy Starlink, the world's most advanced broadband internet system. We design, build, test, and operate all parts of the system – thousands of satellites, consumer receivers that allow users to connect wi ...
-
Tokyo L'Oréal ￥4,200,000 - ￥8,400,000 per yearThe Sr. CRM Planner (LUXE) will be responsible for leading the D2C business strategy and execution, including sales planning, marketing campaigns, and data analysis. · Determine KPIs to measure campaign success · Analyze customer behavior and preferences using CRM data and other ...
-
Tokyo Visa ￥8,000,000 - ￥12,000,000 per yearAs a Senior Consultant supporting Japan market, you will be leading Client Services operational and processing engagements as well as supporting Value-Added Services activities. · Act as a primary point of contact for providing day-to-day operational support to clients. · Establi ...
-
Tokyo VISA ￥10,000,000 - ￥20,000,000 per yearThis Sr. Consultant, Client Success will lead Client Services operational and processing engagements supporting Japan market clients. · Act as primary point of contact for day-to-day operational support. · Foster relationships with clients and internal stakeholders. · Lead cross- ...
-
Tokyo, Japan Visa ￥600,000 - ￥1,800,000 per yearSr. Consultant, Client Success will lead Client Services operational and processing engagements for Japan market. · ...
-
Tokyo Amazon Full time￥15,000,000 - ￥25,000,000 per yearAmazon Web Services (AWS) is looking for highly talented hands on technical architects to help accelerate our growing business. This is an excellent opportunity to join Amazon's world class technical teams, working with some of the best and brightest engineers while also using an ...
