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 turnaround time in one business day. By unlocking the information present in microbial cell-free DNA, we are helping doctors quickly solve their most challenging cases, with a future vision of accelerating clinical trials, discovering new microbes, and reducing patient suffering worldwide.

Position Summary:
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 lead the Clinical Data Management function from the ground up and set the strategic direction for the Clinical Data Management function within Karius.

Reports to:                  Director, Clinical Operations
Location:                     Redwood City, CA

Responsibilities Include:
●      Plan, manage and coordinate all global data management activities for assigned program(s) to ensure consistency of clinical data standards across programs.
●      Critically review protocols and provide feedback as it pertains to data collection and data management activities.
●      Gather, organize, and analyze clinical data and metadata from multiple data sources.
●      Lead design of study databases, case report forms (CRFs) and edit checks and Perform User Acceptance Training (UAT).
●      Perform medical coding and data transfers from EDC to sponsors.
●      Develop and maintain proper study documentation throughout the lifecycle of a study, to include, but not limited to DMP, eCRF Completion Guidelines, Database Specifications, Edit Check Specifications, UAT Test Plan. Identify potential data issues and identify and mitigate risks to data quality.
●      Collaborate with cross functional Clinical sub team (CST) members (i.e. Clinical and Medical Monitors, Adjudication Committees), and key vendors such as central laboratories, clinical sites 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.
●      Ensure completeness, accuracy, consistency and compliance of clinical data and data structure across all assigned programs and drive timely data lock.
●      Lead the data review cycle, query management  and field ad hoc requests for data listings from other functions.
●      Monitor and provide data to Clinical Operations to support clinical operational activities and reports.
●      Partner with Biostatistics to develop and document data repository schema across data sources.
●      Review training tools for site and field staff and provide EDC 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.

Travel:     Travel required 10-15%

Physical Requirements:
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, lab, or clinical environment.

Position Requirements:
●      A Bachelor's degree in Biology or the Physical Sciences (Master's degree is preferred).
●      10+ years’ experience in clinical data management at a biotechnology company or CRO, 8+ years with an advanced degree, diagnostic experience strongly preferred.
●      Experience in managing data management activities for both sponsor-led and outsourced clinical trials.
●      Experience in the use of data standards in the clinical trial environment.
●      Experience with programming in clinical databases such as Medrio, OpenClinica, Oracle.
●      Knowledge of industry standards, such as ICH guidelines, 21 CFR Part 11, and FDA guidelines.
●      Strong understanding of clinical trial processes and EDC platforms.
●      Knowledge of SAS to spec out listing requests to CROs.
●      Experience developing and implementing standards and processes (SOPs).
 
Personal Qualifications:
●      Demonstrated ability to manage complex projects with multiple priorities in a fast paced, team-based environment.
●      Must be an excellent communicator and able to balance complex strategic and operational initiatives including legal/policy and business issues.
●      Ability to anticipate and identify potential roadblocks to meeting goals and identify corrective actions.
●      Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, sites, and external vendors.
●      Must be able to work in a collaborative environment, while often independently,  and consistently demonstrate knowledge, skills, abilities, and behaviors necessary to provide high quality service to both internal and external stakeholders.
●      Ability to prioritize and manage deadlines.
●      Display a high level of commitment and professionalism and is truly passionate about being in the cutting edge of science to help support generate the appropriate clinical evidence.

At Karius, we value a diverse and inclusive workplace and provide equal employment opportunity for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company.  All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at recruiting@kariusdx.com and we will accommodate qualified individuals with disabilities.

Full-time
Redwood City, CA