Responsibilities

• Manage the day-to-day operational aspects of Clinical Trial Team including management of the Contract Research Organization (CRO) and other study vendors for assigned trials.
• Provide efficient updates on trial progress to the senior management, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
• Lead sponsor study startup process, including but not limited to the set-up of trial master file (TMF), site selection and management of vendor contracts and budget negotiation and RFP/vendor proposal process.
• Ensure effective project plans are in place and operational for each trial and work proactively with the clinical team to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
• Ensure potential study risks are escalated to the attention of the senior management when appropriate.
• Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
• Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
• Review and approve vendor responses to quality assurance audits for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
• Ensure all study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
• Effectively provide support to the clinical team in the conduct of the trials including site management and monitoring responsibilities
• Other duties as assigned

Qualifications

• Bachelor's degree in a health care or other scientific discipline or educational equivalent; 5 yrs of experience working on clinical trials with 2-3 years’ experience in a leadership capacity; or equivalent combination of education, training and experience
• Occasional travel
• Advanced knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Strong leadership skills
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
• Strong written and verbal communication skills including good command of English and Chinese
• Excellent organizational and problem solving skills
• Effective time management skills and ability to manage competing priorities

We are an equal opportunity employer and welcome applications from all qualified candidates. We offer competitive remuneration package to the right candidates. Interested parties, please send your full resume with current and expected salary by clicking the "Apply Now".

Information provided will be treated in strict confidence and used for recruitment purposes within our Group only. Personal data of unsuccessful applicants will be retained for a maximum of 12 months.

Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited is an ophthalmic pharmaceutical company dedicated to the discovery, development and commercialization of therapies that address significant unmet medical needs in China. Leveraging our deep domain expertise, we have built a comprehensive ophthalmic drug pipeline of 23 candidates that covers most major ocular indications affecting the front and the back of the eye. We have also established a state-of-the-art ophthalmic manufacturing facility and are assembling an experienced marketing team in anticipation of near-term product launch. Our goal is to become a leader in China and the neighboring ASEAN marketplace. We are now looking for high calibre candidates to join our rapidly expanding team.