Job DescriptionLead the trial team to ensure trial deliverables are met with required quality, resources/budget and timeline. Depends on trial, countries involved in a trial will not be limited to Japan. Accountable for operational management of a trial that includes the planning, set up, conduct and reporting of clinical trials. As Leader of the Trial Team, maintains trial oversight, ensures feasibility of trial plans and pro-actively assesses and mitigates trial risks. Enforces AAI approach and skills in the trial team and trial management. Communicates trial status to stakeholders/senior management on a monthly basis, escalating issues as appropriate. As a CTL, ensure proper implementation of BI SOPs and systems for clinical trial related activities; contribute to continuous improvement within COJ for quality, efficiency and productivity.
RequirementsMinimum Education: Degree, often higher degree/qualification
Major experience focus: Life Sciences
- Practical Clinical research management experience (preferably 5+ years)
- Experience in Therapeutic Area relevant in BI pipeline is desirable
- Understanding of major regulations (US FDA, EMA and PMDA)
- Familiarity with guidelines and standard of care is desirable
- High level communication skills in complex international, cross-functional matrix structures
Enforce AAI approach and skills in the trial team and trial management
- Technical Expertise: Demonstrates knowledge and expertise (plus TA) across all aspects of clinical trial operations and execution. Dimensions of trial complexity include protocol, # patients, # sites, # countries, # vendors. Demonstrates knowledge and expertise in trial management skills including risk management, vendor oversight on trial-level, issue management, communication plan, budget/resource management.
- Leadership and Influence: Candidate's skills and capabilities in addressing complex situations, resolving conflicts, horizontal and vertical influencing.
- Communication: Articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and action. Highly developed receptive communication skills, cultural sensitivity
- Strategic Mindset: Big picture thinker, able to manage through ambiguity. Integrates study strategy with overall TA portfolio. Embraces cross functional initiatives , applying innovative learnings.
- Coordination and Oversight: Candidate's skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources