Mgr Clin Operations
On-siteGuangzhou, Guangdong, China
Job Summary
Oversee, train, and performance manage a clinical operations team using metrics and key performance indicators to drive end results. Conduct regular performance appraisals, career discussions, and recruitment activities while managing induction programs and ensuring accurate timesheet and expense reporting. Deliver training on Working Practice Documents, Standard Operating Procedures, and regulatory standards, identifying gaps to meet requirements. Evaluate staff work through project audits and system reviews of Activate, CTMS, and Preclarus to monitor skills and project status. Collaborate with senior leadership on strategic planning, resource allocation, and process improvement initiatives to enhance department performance. Ensure adherence to ethical and regulatory standards by facilitating quality assurance audits and alerting management to issues.
Required Qualifications
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
- 1+ year of leadership responsibility
- Advanced mentoring/leadership/supervisory skills
- Excellent clinical trials monitoring skills; Remote and on-site
- Demonstrated understanding of or ability to learn the company's SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
- Demonstrated ability to evaluate medical research data
- Strong organizational and negotiation skills
- Strong attention to detail
- Advanced written and oral communication skills
- Good knowledge of English language and grammar
- Demonstrated use of computer to include data entry, archival and retrieval
- Ability to travel as needed
- Excellent teammate with team building skills
- Excellent interpersonal and conflict resolution skills
- Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
- Solid knowledge of medical/therapeutic areas and medical terminology
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