Clinical Data 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 international markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio. 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
Reporting into the Vice President of Biometrics, the Clinical Data Manager will have responsibility for the coordination and completion all data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting. This is an exciting new role within HUYABIO and a key position within the successful outcomes of HUYABIO’s global clinical trial programs.
This is an office-based position that works in a cross-functional and dynamic environment. Clear, timely, professional, and effective communication with all HUYABIO functional areas and global office sites is essential.
Primary Duties and Responsibilities
- Responsible for the planning, managing and coordinating of global data management activities for assigned clinical trial program(s), ensuring consistency, accuracy and integrity of clinical trial data at all times
- Drive the development and maintenance of SOPs, Case Report Forms (CRFs), CRF completion guidelines, edit check specifications, data transfer specifications and database audit plans
- Work cross-functionally with clinical, biostatistics and regulatory teams for the design and development of critical study documents such as Clinical Protocols, Data Management Plans, CRFs, Statistical Analysis plans, vendor specifications, etc
- Participate in the development and implementation of design and programming of clinical databases and its data cleaning procedures
- Perform User Acceptance Testing (UAT) of clinical databases
- Review, analyze and validate clinical trial data throughout its lifecycle of study start-up through close-out activities
- Manage study conduct activities including facilitation of study team data review, documentation of data handling decisions, issuance of data queries and resolution of data discrepancies
- Produce data listings for the clinical team and other functional areas
- Perform database lock and freeze activities in accordance to organizational SOPs
- Perform quality oversight of external vendors
- Other duties as assigned
Job Qualifications and Requirements
- BA/BS degree within a related field
- Minimum 5 years of clinical data management experience within a similar pharma, biotech or CRO environment is required
- Experience within core clinical data management activities (data management plans, edit specifications, electronic data transfers, data quality reviews and reporting)
- Working knowledge of FDA regulations, GCP and ICH guidelines as it relates to data management is required
- Strong understanding of drug development and its associated clinical trials
- Experience with Clinical Database Systems is required
- Experience with oncology or cardiovascular clinical trials is preferred
- Ability to work collaboratively with internal team members and external collaborators
- Excellent communication, written and interpersonal skills
The position is full‐time, and the candidate must be within commuting distance to HUYABIO’s Del Mar, CA headquarters. Interested candidates should submit resumes to: firstname.lastname@example.org.
To learn more about HUYABIO, please visit www.huyabio.com. HUYABIO International is an equal opportunity employer.