Calithera Biosciences Inc. Sr. Manager/Associate Director, Data Management in South San Francisco, California
Senior Manager/Associate Director, Data Management
We are currently recruiting for a Senior Manager/Associate Director, Data Management. This role is accountable for ensuring study start-up, conduct, and closeout are performed according to data management best practice, Standard Operating Procedures (SOPs), and Good Clinical Practices (GCPs), to fulfill all federal and local regulations. Duties include serving as the primary data management liaison with vendors and senior management.
Calithera Biosciences is a clinical-stage biopharmaceutical company pioneering the discovery and development of targeted therapies that disrupt cellular metabolic pathways to preferentially starve tumor cells and enhance immune-cell activity. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer and other life-threatening diseases, Calithera is advancing a pipeline of first-in-clinic, oral therapeutics to meaningfully expand treatment options available to patients. Calithera is headquartered in South San Francisco, California.
Provide supervisory and leadership management to Data Management (DM) as a functional group.
Oversee DM vendors to ensure the data are complete, accurate, and delivered within the timelines and budget agreed to.
Serve as the Lead DM for clinical studies.
Lead the design of the eCRFs and ensure that they support the clinical study objectives.
Ensure complete and accurate DM documentation are in place, such as eCRF specifications, eCRFs completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, and data management plans.
Ensure data are reviewed by cross functional team on an on-going basis .
Develop data quality review plan and ensure all reviews have been completed and all documentation has been finalized and approved for final database locks in a regulatory-compliant manner.
Act as team SME for key systems and processes, and lead process enhancement efforts.
Mentor, train, and support data management staff.
Budget study cost and manage work and change orders.
Ensure compliance with applicable Corporate Policies and procedures.
Manage and communicate progress and expectations with cross functional leaders and senior management team.
Bachelor's degree in health science or equivalent, with 10+ years of data management experience (Oncology experience highly desirable), including vendor management experience and supervisory experience preferred.
Knowledgeable in GCP standards, CDISC standards, FDA and ICH guidelines, and recommended CDM Best Practices.
Experience developing and maintaining CDM SOPs.
Electronic Data Capture (EDC) experience .
Demonstrate effective verbal and written communication.
Demonstrate expertise in overseeing vendors and leading teams during data management start-up, conduct, and close out of trials.
Must have experience leading matrixed teams.
Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.
To learn more information about this position: www.calithera.com/culture.