Sr. Clinical Trial Manager
HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.
The Sr. Clinical Trial Manager (CTM) manages the execution of clinical trials, including vendors (e.g., Clinical Research Organization) and study sites related issues, with supervision from the Vice President, Clinical Operations, of which this position will report into.
This is an office-based position that works in a cross-functional and dynamic environment. Clear, timely, professional, and effective communication with all HUYA functional areas and global office sites is essential.
Primary Duties and Responsibilities
- Manage study timelines & quality of deliverables from vendors, and manage approved trial budget(s) throughout the life of the assigned clinical trial(s)
- Participate in the selection of study vendors as appropriate, including obtaining cross-functional agreement of vendor scope, negotiate vendor budgets and business terms of Work Orders
- Monitor CRO and vendor performance, provide clear scope, expectations, and guidance, address vendor performance and escalate issues as appropriate
- Develop the study monitoring plan in collaboration with vendors and study timelines
- Contribute to clinical protocol drafting, amendment, ICF, regulatory and IRB/ethics submissions, clinical data compilation, cleaning, database lock preparations, and clinical study reports
- Contribute to study data review and other review activities as assigned
- Oversee clinical trial sites’ adherence to pertinent regulations through review of monitoring reports, CQA-GCP audit report, communications with investigators, study site personnel, CRAs, and other CRO/designee personnel
- Identify and provide solutions to clinical trial issues and/or risks
- Provide training to vendors on assigned protocol specific topics
- Travel to site visits, co-monitoring visits, Investigator Meetings, and conferences as applicable
Job Qualifications and Requirements
- Thorough understanding of FDA, ICH and GCP guidelines
- Proven track record showing clear proficiency in clinical trial management skills
- Proven complex problem-solving skills collaboratively and independently
- Solid vendor management experience, e.g., CRO, laboratory, and clinical supply logistics
- Broad understanding of clinical operations related to pharmaceutical drug development process
- Detailed understanding of all aspects of oncology clinical protocol design and implementation & overall drug development
- Ability to effectively interface with personnel at clinical sites
- Ability to write and edit technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
- Excellent interpersonal, verbal, and written communication skills
- Ability and willingness to travel internationally and domestically
Education and Experience
- BA, BS in biological science, or degrees in nursing, pharmacy, medical technology, or other allied healthcare
- Minimum of 7 years of clinical trial management experience, at least 4 of which are as a Clinical Trial Manager for clinical development studies at a pharmaceutical/biotech organization or a combination of CRO and pharmaceutical/biotech, excluding OTC drugs
- Experience with Phase I – III clinical trials
- Proficiency with computer programs such as Microsoft Office suite
This position is full‐time, and the candidate must be within commuting distance to HUYABIO’s Del Mar, CA headquarters.