Job Openings

Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. At Lyell, our goal is to change that. We are a clinical-stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for solid tumors based on our innovative technologies. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to defeat solid tumors, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency.

 

This role is responsible for providing timely, professional, and precise ongoing quality management of clinical trial data in a fast-paced, rapidly evolving environment.  The incumbent will govern the data review cycle by implementing metrics reports, discrepancy listings, and other data review tools, and fielding ad hoc requests for data listings from other functions such as Translational Science.  This role is responsible for tracking important study metrics on data entry, source verification, and query status, for performing quality control on those metrics to ensure accuracy. 

KEY ROLES AND RESPONSIBILITIES:

• Manages and coordinates the activities of internal teams and external vendors
• Plans,organizes, and coordinates global data management activities on a study or program basis
• Ensures database consistency within a study and across studies
• Reviews data management performance against established metrics
• Identifies issues and creates training tools for site and field staff
• Participates in process improvement activities, defining and implementing the changes required to create an industry-leading clinical data capacity

PREFERRED EDUCATION:

• BA/BS with a minimum of 10 years’ clinical data management experience in biotechnology or pharmaceutical industry

PREFERRED EXPERIENCE:

• Experience with clinical trials in oncology
• Experience with biomarker data management
• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment

 PREFERRED KNOWLEDGE, SKILLS AND ABILITIES

• Demonstrated knowledge of FDA, EMEA, and ICH guidelines
• State of the art understanding of data standards (CDISC, CDASH, HL7) in the clinical trial environment
• Working knowledge of Medidata Rave and Bioclinica Express.
• Proven customer-service orientation, high degree of professionalism, and ability to work with limited direction
• Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks
• Ability to multi-task and shift priorities quickly while working under tight deadlines

 

 

 

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.

 

We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.