Senior Manager, Clinical Data Management (South San Francisco, CA)
Sutro Biopharma, Inc. is looking for a talented and driven individual to join our team. The Senior Manager, Clinical Data Management should have a good working 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 Clinical Data Management components, study budgets and vendor performance to ensure the highest standards of data integrity within the timelines and budget.#Li-DNI
- Manage the planning, implementation, and overall direction of executing clinical trial data management activities including protocol review, electronic system configuration, Case Report Form (CRF/eCRF) design, database development, validation programming, and discrepancy management.
- Represent data management on study teams, providing accurate study status and timelines, and proactively communicating data management risks.
- Manage/oversee EDC database builds including CRF design, edit check specifications, and validation of the clinical database.
- Manage/oversee CRF completion guidelines, data management plan, data review plan, and 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 ensure data integrity and consistency.
- Organize on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies.
- Facilitate the correction of errors and discrepancies through the site query process, document permanent data issues, communicate issues with team members, and deliver a quality locked database for analysis.
- Assess time and resource estimates for project planning and timeline management for studies/projects.
- Participate in data management vendor selection and supervise data management service providers (EDC, labs, biomarker etc.) to ensure high quality and on time 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 trials, data collection, clinical data structures, and relational databases.
- 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 managing CROs is preferred.
Sound exciting? Apply today and join our team!
Sutro Biopharma, Inc. requires all new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Sutro will consider requests for reasonable accommodations.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.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
Salaries listed on jobsites may not be representative of salary ranges at Sutro Biopharma.
We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies.
Sutro Biopharma, Inc., located in South San Francisco, is a clinical-stage drug discovery, development and manufacturing company. Using precise protein engineering and rational design, Sutro is advancing next-generation oncology therapeutics.
Sutro is dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro’s platform has led to cytokine-based immuno-oncology therapies, ADCs, vaccines and bispecific antibodies directed at precedented targets in clinical indications where the current standard of care is suboptimal.
The platform allows it to accelerate discovery and development of potential first-in-class and best-in-class molecules through rapid and systematic evaluation of protein structure-activity relationships to create optimized homogeneous product candidates.
In addition to developing its own oncology pipeline, Sutro is collaborating with select pharmaceutical and biotech companies to discover and develop novel, next-generation therapeutics. As the pace of clinical development accelerates, Sutro and its partners are developing therapeutics designed to more efficiently kill tumors without harming healthy cells.