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Precision Medicine Group delivers specialty services that help its life science clients navigate healthcare challenges. The company entered its 10th year of suc
Clinical Trial Manager – Shanghai, Beijing
Location
China
Posted
10 days ago
Salary
0
Seniority
Senior
Job Description
Clinical Trial Manager – Shanghai, Beijing
Precision Medicine Group
• Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies • Primary clinical point of contact with the client • Collaborate with PM on monthly invoicing and variance management of clinical budget • Develop study related clinical documents • Identify and develop training needs for CRAs and third-party vendors • Generate potential site list from key stakeholders and drive site feasibility process • Identify potential risks to the enrollment targets • Develop timely and effective communication and good working relationships with investigators and study team • Lead internal clinical team meetings and sets expectations for clinical team • Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log • Support in planning and conducting investigator meetings • Review and/or approve of IP release packages • Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies for assuring study timelines are met • Responsible for eTMF implementation and management • Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) • Assist sites, internal staff and CRAs with preparation for GCP audits • Work closely with PM for project-specific resourcing issues • Escalate pertinent CRA performance and site compliance issues • Collaborate with data management and CRAs to ensure data quality • Manage processes for investigational product (IP) including drug accountability and reconciliation • Supports business development and marketing activities
Job Requirements
- Bachelor’s degree or equivalent combination of education/experience in science or health-related field
- Minimum of 5-8 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience
- Oncology (Phase I) trial experience in Taiwan and China preferred
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Professional development opportunities
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