上海招聘

Key Responsibilities:

• To ensure clinical research to meet mandatory compliance requirement and standards including ICH-GCP, SOP/guideline and regulatory requirement.
• Resolve site non-compliance and data quality issues (violations on protocol, ICH GCP, SOPs) and escalate the issues to Line manager in agreed timeline.
• To enhanced efficiencies and quality to initiate process improvements aligned with line manager.
• Develop and drive the local training process and delivery
• Ensures team to receive necessary training, i.e. TA, study and SOPs
• Seek out and build competence in therapeutic knowledge through trainings, etc;
• Contribute to site inspection readiness and trial quality oversight

Key Activities:

• Identifies successes, risks, and action plans on study issues following SOP/regulation/compliance requirement
• Design, lead and oversee the training programs based on function needs;
• Lead process improvement and initiative aligned with internal & external team on quality, cost, and time
• Ensure function staff to update individual training record in time and file accordingly.
• Conduct Accompany site visit with CRA;
• Support site inspection readiness and trial quality oversight if assigned

Recommended Education and Key Competency:

Basic Qualifications

• Minimum Bachelor degree major in medical, biology, pharmacology or other life sciences subject
• Minimum 7 years of clinical operation experience including 5 years in monitoring clinical research
• Good knowledge of product development process, clinical trial monitoring procedures, GCP guidelines and medical terminology.

Preferred Qualifications

• Prefer to be involved in self-inspection, audit, and inspection readiness.
• Prefer to have experience on study management, trainer, line manager.

Knowledge

• Extensive knowledge of ICH/GCP regulations and guidelines
• Advanced knowledge of China clinical trial management including regulations and guidelines
• Clinical trial processes and operations

Key Competencies

• Strong presentation skills or training skills
• Strong communication skills
• Can-do attitude and willingness to take challenge tasks
• Ability to work within team
• Critical thinking and Problem solving
• People management
• Leadership skills including decision making, influence skills, stakeholder management
• Ability to work effectively in a changing environment
• Language: Chinese & Business English fluency