Director, Data Management - San Diego, CA or Remote

Director, Data Management -  San Diego, CA or Remote

We’re a different kind of biotech company.  And we’re here to make a difference.

Prometheus Biosciences, Inc. (Nasdaq: RXDX), is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases. 

The Company’s precision medicine platform, Prometheus360™, combines proprietary machine learning-based analytical approaches with one of the world’s largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets.   Headquartered in San Diego, Prometheus Biosciences, Inc. was named Best Places to Work by Biospace, San Diego Business Journal and is a Great Place to Work-Certified™ Company. 

Summary 
The Director of Data Management will serve as lead clinical data manager for clinical studies as assigned and responsible for providing input to protocols, design, and review case report forms, providing input to database development, and performing all data management-related activities.  In addition, this role will be an internal expert in data management related systems and oversee CRO processes and deliverables. This person is expected to ensure that the clinical data management elements are in line with the overall deliverables and to ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements. 

 
Key Duties and Responsibilities

• Perform data management study activities and manage timelines during study start-up, study conduct, database lock, and documentation archival             
• Conduct oversight of Data Management Clinical Research Organizations (CROs) by ensuring data management documents and tasks are completed and delivered in accordance with timelines and data quality standards             
• Oversee and Drive develop study-relate deliverables, such as Electronic Case Report Forms (eCRFs), Data Transfer Agreements (DTAs), etc.
• Participate and serve as an expert in the implementation and User Acceptance Testing (UAT) of clinical systems such as Electronic Data Capture (EDC), Interactive Response Technology (IRT), electronic Clinical Outcome Assessment (eCOA), and data visualization tools
• Coordinate cross-functional data review within the company and with CROs
• Provides proactive, timely communication of project status, data trends and issue resolution

Education and Experience

• Bachelor’s degree required
• 8 plus years data management experience in the Pharmaceutical, Biotechnology, or Contract Research Industry
• Hands-on knowledge of data management activities, clinical database design, specifically electronic data capture from various vendors
• Experience in overseeing CROs with respect to the processes and deliverables
• Experience in implementing and customizing systems to fit the trial needs
• Knowledge of Study Data Tabulation Models (SDTM) and experience transforming raw data into those standards

Skills and Abilities

• Strong knowledge of Clinical Data Management (CDM) processes and key documents such as Case Reporting Form (CRF) development, database set-up/lock activities, Data Management Plan (DMP), etc.
• Knowledge of Good Clinical Practice (GCP), ICH, and Regulatory requirements
• A commitment to collaborative leadership, management, teamwork, delegation, and a professional culture based on trust and mutual respect
• Excellent interpersonal, reading, writing, communication and public presentation skills, along with exceptional organizational skills
• Successful track record of working in a matrixed organization and building strong relationships with other functions and contractors/vendors
• Strong problem and conflict-resolution skills
• Exceptional business acumen, analytical skills
• Ability to develop, and manage expenditures in accordance with budget 
• Travel up to 25% of the time

 The anticipated base pay range for this position is $85,000 to $285,000. Individual pay is determined by job-related skills, experience, and relevant education or training.