Clinical Data Management III
Location: Burlingame, CA
Position Type: Full time
Role and Responsibilities
- Review clinical study protocol development.
- Collaborates and coordinates with cross-function members to design, test and implement data collection systems, such as case report forms (CRF), interactive web response systems (IWRS), and electronic data capture systems (EDC).
- Develops data quality plans and metrics
- Manage vendors and contract research organizations (CRO) including generating timelines
- Proactively and effectively oversees data management activities, identify and resolve issues when arise with internal and external relevant parties.
- Demonstrate knowledge of hands-on effort
- Ensures projects are conducted in compliance with operating procedures and good clinical practices
- Ensures CDM project documentation is in an audit-ready state
- Author and review CDM operational documents such as SOPs, Work Processes, and associated documents affecting CDM
- Represent data management on project teams, promote and maintain positive, productive, and collaborative working relationship with internal customers and external vendors
- Recommend alternative work processes to improve on CDM process, timeliness and data quality and integrity
- Support regulatory submission activities for assigned projects
- Ensure project Deliverables/Timelines schedules are completed on time
Qualifications and Education Requirements
- Minimum of 8 years progressive growth experience in Pharma/Biotech/CRO setting
- Minimum 5 years of recent Oncology trials data management experience
- Minimum 5 years of experience using clinical data management systems including EDC products (e.g. RAVE, Inform, BioClinica, etc.)
- Knowledge of clinical research, FDA & ICH, GCP, GCDMP, and related regulatory requirements
- Proficiency in Microsoft Office tools
- Strong interpersonal skills
- Demonstrated capability of working on multiple projects simultaneously
- Ability to complete deliverables on time and adjust priorities in a fast-paced environment
- Ability to work independently as well as collaboratively in a team environment
- Flexibility and willingness to solve problems that fall outside of immediate area of expertise
- Bachelor’s degree or equivalent experience required
Join our Team
Local candidates only please!
If you are interested, please submit a cover letter and your resume to firstname.lastname@example.org