Clinical Data Manager | Karius

Clinical Data Manager

Karius is a venture-backed life science startup focused on transforming the way infectious diseases are diagnosed.  Combining Next-Generation Sequencing and proprietary data analysis, we can identify over 1,000 pathogens from a single blood sample with typical turn around time in one business day. By introducing liquid biopsy into the diagnosis of infectious diseases, we're helping doctors quickly solve their most challenging cases, with a future vision of accelerating clinical trials, discovering new microbes, and reducing patient suffering worldwide. 

We are looking for a Clinical Data Manager to own all clinical data management activities for clinical programs to ensure accurate, high quality management of clinical trial data for outsourced trials in a fast-paced environment. She/he will build and manage the Clinical Data Management function within the Medical group from the ground up.

This position will report into the Head of Clinical Affairs and will set the strategic direction for the Clinical Data Management function within Karius.

You Will:
·       Gather, organize and analyze clinical data and metadata from multiple data sources
·       Recruit, train and develop members of the Clinical Data Management team
·       Develop a strategy to select and implement appropriate data management systems
·       Develop data management service provider oversight strategy for Karius clinical trials
·       Plan, manage and coordinate all global data management activities for assigned program(s) to ensure consistency of clinical data standards across programs
·       Collaborate with cross functional Clinical sub team (CST) members and vendors to meet project deliverables, including data acquisition, quality checking and reporting in compliance with GCP, SOPs and regulatory requirements
·       Manage and lead the design and implementation of clinical data management processes with vendors
·       Oversee the development of study-specific data management plans and identify potential data issues and identify and mitigate risks to data quality
·       Ensure completeness, accuracy and consistency of clinical data and data structure across all assigned programs
·       Lead the data review cycle and field ad hoc requests for data listings from other functions
·       Review training tools for site and field staff and providing ad hoc training, as needed
·       Represent data management at investigator meetings and may present EDC and case report forms to investigators
·       Participate in internal study team meetings as well as teleconferences with outside vendors and study personnel

You Bring:
·       B.S. or B.A. required, MBA, M.S. or M.A. preferred
·       10+ years experience in clinical data management at a biotechnology company or CRO, 8+ years with an advanced degree, diagnostic experience strongly preferred
·       Proven experience managing individuals
·       Experience in managing data management activities for outsourced clinical trials
·       Experience in the use of data standards in the clinical trial environment
·       Knowledge of SAS in order to spec out listing requests to CROs
·       Excellent presentation, communication, written, and interpersonal skills
·       Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, team-based environment
·       Experience developing and implementing standards and processes (SOPs)

Redwood Shores