Senior Clinical Data Manager
Sutro has a unique capability that enables new molecular entities to be designed using a hybrid of synthetic and recombinant technologies to create best in class therapeutics in the oncology and auto-immune disease space. Our portfolio includes antibody-drug conjugates, bispecific antibodies, cytokine derivatives and other novel immuno-stimulatory approaches.
The Senior Clinical Data Manager should have a good knowledge of clinical research and data management processes to support drug development. The role will be responsible for all aspects of clinical data management activities with minimal supervision. They will manage all CDM components, study budgets and vendor performance to ensure the highest standards of data integrity within timelines and budgets.
- Be responsible for data management activities from initiation of protocol through database lock
- Represent data management on study teams, providing accurate study status and timelines, proactively communicate data management risks
- Manage/oversee EDC database specifications, CRF design, validation of clinical database, CRF completion guidelines, data management plans, data review plan, data transfer agreements with vendors (e.g., clinical laboratories, imaging vendors) etc. to ensure a high quality of data and compliance with applicable industry regulations and standards
- Collaborate with different functional groups across the organization to data integrity and consistency
- Manage data query, review, cleaning process to minimize inconsistencies, missing, or errors
- Assess time and resource estimates for project planning, timeline management for studies/projects
- Participate data management vendors selection and supervise DM service providers (EDC, labs, biomarker etc.) to ensure high quality and timely deliverables
- Develop, review and revise SOPs and Work Instructions, maintain data management internal files, and contribute towards process improvement and data standardization
- Bachelor’s degree in life science, computer science or equivalent relevant degree
- Familiar with major EDC systems
- Thorough knowledge of clinical trial, data collection, clinical data structures, relational database, and data exchange
- Strong collaboration and excellent verbal and written communication skills
- Project management skills and ability to work in a cross-functional team environment
- Ability to manage multiple complex projects and priorities with minimal supervision
- Knowledge of GCP, CDASH/CDISC
- Responsibilities may require out of “normal” work hours to meet business demands
- 10+ years of experience in Data Management for Pharmaceutical/ biotech/ CRO
- Experience in managing CRO is preferred
Sutro provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, ESPP (Employee Stock Purchase Plan) and stock options.
Sutro Biopharma is committed to the diversity of our team and we are committed to Equal Employment Opportunity without regard for race, ethnicity, gender, protected veteran status, disability, sexual orientation, gender identity or religion.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.
Please be advised, inquiries or resumes from recruiters will not be accepted.