Senior Manager, Clinical Data Management
Clinical Data Management | South San Francisco, CA | Full Time
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Position: Senior Manager, Clinical Data Management
The Senior Manager, Clinical Data Management will manage the operational aspects of clinical data management supporting the global drug development activities of a program. The primary focus for the Sr. Manager, Clinical Data management will be to manage and perform the end-to-end clinical data management activities for their assigned clinical program, while ensuring the highest level of data quality and compliance. The position requires a detailed knowledge of clinical data management processes, platforms, software, clinical trial databases, and the Pharmaceutical drug development process. The successful candidate will provide direction and guidance to the Clinical development team members, including consultants and vendors, as well as other functional groups, while leading and performing clinical data management activities within the drug development program. This position currently reports directly to the Head of Clinical Data Management.
Responsibilities include, but are not limited to:
- Provide leadership, representation and guidance to the internal and external team as the Global Clinical Data Management representative for a product development project at Allogene by exemplifying a high performance and collaborative culture
- Ensure adherence to industry guidelines and inspection readiness by maintaining current documentation, adherence to SOPs and compliance with training
- Work collaboratively with internal and external team members within the program to coordinate the planning and execution of day to day data management deliverables
- Provide expertise and guidance to the clinical development team regarding data standards, leveraging CDASH and CDISC
- Effectively interact with senior members at Allogene for strategic planning to ensure internal standards in accordance with corporate objectives and goals
- Oversee database status with respect to key performance indicators, metrics, and program level deliverables and timelines
- Proactively work collaboratively with team members to identify risks and execute risk mitigation strategies
- Contribute to project resource planning, re-forecasting, and program deliverable timeline creation
- Other duties as assigned
Position Requirements & Experience:
- Bachelor’s degree (or higher) in Life Sciences or other closely related field
- 7+ years of experience in Clinical Data Management
- 5+ years of experience performing as a hands-on clinical data management lead
- Experience in regulatory GCP inspections/audits is a plus
- Successfully manage clinical data management vendors, contractors and service providers for program deliverables
- Experience in Oncology and/or Immuno-oncology trials preferred
- Ability to handle multiple projects within a program
- Flexible to changing priorities, and detail-oriented, with initiative to take on unfamiliar tasks
- Demonstrated ability to establish and articulate a plan for a team to ensure appropriate focus and direction
- Good analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development
- Understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies required
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Candidates must be authorized to work in the U.S.
As an equal opportunity employer, Allogene Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.