Clinical Trial Leader

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Job details

Company overview

We are a foreign pharmaceutical company. Through a merger with an international biopharmaceutical company, we have introduced innovative biotechnology to the Japanese market. Through highly specialized medical information activities, we are enhancing our presence in the Japanese market. Focusing on cancer, cancer immunotherapy, and infertility treatment, we provide innovative healthcare solutions to the people of Japan.

Responsibilities

• Leads the development of the clinical trial strategy and delivers the clinical operational plan within the budget, timelines and quality standards agreed upon by Governance Committees.
• Accountable for oversight of CROs in the execution of Phase I – III global clinical trial(s).
• Represents Global Clinical Operations (GCO) within the Global Trial Team and serves as the key GCO operational point of contact for the trial.
• Accountable for the successful preparation and presentation of operational content at key governance discussions
• Key contributor to the development of annual trial/project objectives and communicating to relevant line management and Clinical Operations Team
• Drives and leads the successful execution, oversight and approval of all clinical trial documents and operational plans of global clinical trials using strong project management, leadership, and organizational skills.
• Ensures strong oversight, review and delivery of trial/project CAPAs in order to meet corporate compliance standards and timelines.
• Accountable for partnering with CRO in audit responses and addressing quality issues.
• Provides leadership and contributes to all operational aspects of the trial budget, including forecasts to ensure delivery within the R&D financial standards.
• Performs review and provides strong operational input in the development of clinical trial protocols, ICFs and CSRs and contributes as a member to the CTM Internal Protocol Review Committee.
• Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges.
• Supports the development and implementation of department initiatives including input on SOPs, processes, and workstreams.
• Ensures strong inspection readiness application for all assigned clinical trials.
• Manages a small project or project stream with tasks of low to moderate complexity within a larger project. Leads a small project team with members typically from direct working environment and a straightforward project structure. Coordinates stakeholders from own area or even closely related areas or is partially or even fully responsible for the project’s management within small to medium sized projects. Applies technical expertise in the analysis of factual information and may even look beyond the immediate problem and use business acumen to understand the wider implications.
• Accountable for projects within a clearly defined scope and milestones. Receives moderate to low level guidance and direction within broad guidelines.

Requirements

• Handles, oversees and prioritizes multiple tasks simultaneously; good time management skills; works with moderate supervision; highly self-motivated and proactive.
• Ensures studies are run according to plan and expectations, ultimately resulting in timely and high-quality delivery of projects; directs daily operations of clinical study(ies) to meet expected timelines and achieve milestones while ensuring quality and adhering to budget.
• Finds creative solutions to problems and make suggestions for the improvement of existing processes
• Thinks beyond the confines of own function; considers interfaces and actively fosters cross-functional cooperation, ability to manage internal and external customers; Knows his/her customers, builds relationships and treats them with professionalism
• Anticipates, recognizes, and manages issues: Analyzes clinical study and investigative site risks and implements corrective actions, where required. Applies critical thinking skills.
• Collaborates with vendors and verifies each is meeting expectations according to scope of work and budget on assigned study. Utilizes technology and available sources of data to verify vendors are on target for deliverables in an ongoing manner.

Salary

12 - 17 million yen

Location

Tokyo