- The position is responsible for the successful execution of local, regional, and/or global clinical trials for assigned programs/projects within a Therapeutic Area (TA), including adequate planning and resource allocation, producing deliverables within as per timelines and budget; all aspects of the trial must be of high quality, meeting all the SOP and regulatory mandates.
- This position acts as the single point of accountability at the program/project level and has a direct interface with the Japan Compound Team (JCoT) and/or Global Clinical Development Operations (GCDO) in the management of clinical trials. As applicable, this position is responsible for the coordination of all activities performed by the Japan Clinical Operation Leader (JCOL) & Local Trial Manager (LTM) assigned to her/his program/project and is also responsible for the line management and development of all JCOLs & LTMs.
1. Initiates assigned programs/projects.
- Establishes interaction as a primary member of the JCoT with other assigned members of the JCoT.
- Coordinates with the JCoT on the accurate planning of trials within the program/project;
- Ensure that information is available to the JCO.
- Provide operational input into Japan Development Plans and answers to key operational TA questions from members of the JCoT.
- In close interaction with the JCoT, ensures that the JCO/GCDO promptly receives Protocol Designs Elements/Protocol and the critical TA operational questions important for protocol feasibility, allowing optimal preparation of the trial.
- After JCOL(s) & LTM(s) assignment, support the activity as the line manager.
2. Drives the execution and closure of assigned programs/projects.
- As applicable, discusses the availability of JCOLs/LTMs with the director of the Trial Lead Department, procure them, and be accountable for their performance
- Is apprised of the efforts of the Japan Clinical Team (JCT) in all its programs/projects and ensure operational consistency.
3. Provides the key input for resolving issues and can escalate decision making for assigned
- Communicates timely trial updates and issue escalation to the Director of the Trial Lead Department.
- Reviews proposals for action plan(s) developed by the JCOLs and JCTs.
- Works with the JCoTs and JCTs to implement solutions on a program/project level.
4. Ensures that project operational objectives conform to all relevant laws, regulations, guidelines, and internal SOPs/policies as laid out in the “End to End” (E2E) process for clinical trials.
5. Manages and develops all JCOLs/LTMs assigned to her/his program/project.
6. HR management of JCOLs & LTMs.
- Evaluates the performance of group members and provides input to the Director.
- Consults with the Director on resource management for group members.
- Owns responsibility for the long-term career development of group members.
7. Acquires and sustains advanced knowledge of the therapeutic area and product and clinical trial setting in the TA
- At least 10 years operations experience in clinical trials with a pharmaceutical company and/or a CRO are preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering a candidate’s eligibility.
- People management experience is strongly preferred.
- Expertise in the areas of drug development and strategic planning, specifically in relation to the management of clinical trial operations is required. A full understanding of all logistical aspects when conducting local, regional, and/or global clinical trials are also required.
- Demonstrated experience managing and mentoring clinical operations team members.
- Excellent leadership skills and a proven ability to foster team productivity and
cohesiveness is required.
- Excellent decision-making and communication/collaboration skills are essential to this position as are, analytic skills and effectiveness in seeking solutions to issue.
-A Bachelor’s Degree (or equivalent) is required. An advanced degree in ascientific discipline and/or a Master’s Degree is preferred.
Janssen Pharmaceutical K.K. (7195)