Position is responsible for decisions affecting the ultimate quality of the product, including regulatory compliance, data quality, patient safety, and investigator relations. Contributes to efficient and timely execution of clinical trials, thereby benefiting cost control, company reputation with future prescribers and patients, and future revenue.
KEY DUTIES AND RESPONSIBILITIES:
1. Scope
• Ensure that the scope, all tasks and responsibilities for a study are appropriately reflected in all study contracts and amendments. Ensure that scope changes are appropriately endorsed and reflected in respective contracts before implementation of activities by the vendors.
• Develop, communicate and evaluate trial management plans to include trial team objectives, workflows, and timelines.
• Supervise study conduct by regularly reviewing external vendors’ performance through the review of KPIs, metrics and deliverables, with a focus on critical activities that might delay the project, jeopardize quality, and/or impact on budget.
• Perform other tasks as deemed necessary by the Company.
2. Communication
• Familiarize with the competitive landscape; engage with KOLs, investigational sites, and other relevant organizations and vendors.
• Work closely with the PL (Project leader), other team members and stakeholders as required and serve as the internal key contact for their assigned studies.
• Identify issues/gaps in processes and interfaces with other groups and departments and contribute to developing recommendations for resolution.
• Appropriately escalates issues in a timely manner and endures resolution.
3. Quality and Risk
• Ensure quality and adherence to the relevant HUA SOPs, GCP/ICH-GCP, regulatory guidelines and working practices. Support any audit/inspection activities to ensure that result findings from audits/inspections are appropriately addressed in a timely manner.
• Ensure a risk assessment is performed with Quality Department.
• Conduct QC visit to sites to ensure trial quality standards are maintained.
QUALIFICATIONS (KNOWLEDGE, EXPERIENCE, ABILITIES & SKILLS)
1. Experience and Knowledge
• Bachelor degree in relevant major. Advance degree is preferred.
• Above 3-5 years’ relevant experience in clinical development including at least 1-2 years’ team leadership.
• Must have a thorough knowledge of clinical research concepts, practices, and relevant resources.
• Regulatory and policy on drug registration in China, MAH, and GXP relevant.
2. Abilities
• Responsibility: response for company, project process, milestones and tasks in own domain.
• Planning: able to systematically think and analyze the company's business development in relevant area of responsibility, and formulate corresponding plans; Timely adjustment according to the external environment to meet the needs of the company's business development;
• Decision-Making: make a correct decision based on the analysis and judgment of the external environment. Ability to fully and accurately analyze and evaluate the strengths and weaknesses, risks and benefits of different programs and to make decisions that are superior to those of their peers.
3. Skills
• Clinical trial management and team leadership.
• Proficiency in the Microsoft office suite.
• Good interpersonal skills.
• Excellent time management and organizational skills.
• Negotiation skills.