Associate Director, Clinical Data Management
At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Courage and Collaboration and it reflects who we are and the environment we are creating.
You will be responsible for the leadership of Clinical Data Management (CDM) that supports the clinical development programs including the development and implementation of data management processes, data standards, data management plans and vendor oversight. Additionally, you will lead all aspects of data management activities of clinical trials and are expected to work closely with cross-functional teams including biostatistics, clinical operation, clinical science, safety science, statistical programming and translational research. This role could sit in either our South San Francisco or Seattle office.
KEY ROLE AND RESPONSIBILITIES:
- Leads the strategy and development of the Clinical Data Management Systems in support of data deliverables for clinical trials.
- Establishes CDM processes and procedures to ensure clinical data security, integrity and quality.
- Develops and implements clinical data standards, data management plans, data transfer agreements, and data flow processes to ensure timely and quality data delivery for analysis purpose.
- Oversees the process to identify, evaluate and select vendors for CDM activities.
- Manages vendors and oversees CDM’s deliverables to ensure the quality of data collection, data review and data cleaning, and ensure the timelines are met.
- Serves as the Lead Data Manager for clinical trials and works closely with cross-functional teams to ensure compliance with regulations, policies, procedures, and clinical objectives.
- Manages budget and resource planning across multiple projects.
- Leads, designs and/or oversees eCRF design, eCRF specifications, eCRF completion guidelines, annotated CRFs, User Acceptance Test, edit checks, data query resolution, SAE reconciliation between clinical and pharmacovigilance database, data migration and database closeout for clinical trials.
- Provides subject matter expertise to study team members during all phases of clinical trials.
- BA/BSc with a minimum of 3 years’ experience.
- Minimum 8 years of clinical data management experience in biotechnology or pharmaceutical industry, with vendor oversight experience.
- Experience with clinical trials in oncology (hematology-oncology or solid tumors) is required.
- Experience with cell therapies.
- Experience with biomarker data management.
KNOWLEDGE, SKILLS AND ABILITIES:
- Advanced knowledge and experience of Data Management processes and systems.
- Solid understanding of overall drug development process and early phase clinical trials.
- Solid understanding of CDASH and CDISC standard.
- Solid understanding of ICH guidance, GCP standard and 21 CFR Part 11.
- Solid understanding of MedDRA and WHODrug dictionaries.
- Hands-on experience with multiple EDC systems (e.g. Rave, OmniComm, Medrio, etc).
- Excellent verbal and written communication skills and the ability to work well in a team.
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.