CRM Data Team Manager - Oregon Health & Science University

Department Overview:

The OHSU Knight Cancer Institute, known as one of the pioneers in personalized cancer medicine, is an international leader in research and cancer treatment. Driven by its mission to end cancer as we know it, the institute is building upon its expertise in targeted treatments to advance the early detection of cancer when the disease is most treatable.

 

SMMART (Serial Measurements of Molecular and Architectural Responses to Therapy) is the flagship program of the Knight Cancer Institute's Precision Oncology program. SMMART aims to revolutionize cancer research and treatment by developing innovative treatment regimens that last longer and allow a better quality of life for patients at all stages of cancer. Through comprehensive and longitudinal analysis, the SMMART program evaluates each patient¿s individual cancer tumor with the mission to understand why standard therapies often stop working, and to develop novel combinations that may stop cancers from becoming resistant to cancer drugs. SMMART is a highly adaptive, fast-paced, clinical research environment. We work to support the conduct of translational clinical research, aimed at improving the lives of people and families with cancer, by applying innovative strategies for cancer prevention, screening, diagnosis, and treatment that is uniquely tailored to each patient. We support this model through proactive, high quality, and efficient study management in compliance with federal regulations and local policies and procedures. We navigate the complex world of oncology and clinical studies, and work with a very vulnerable and sick population. 

 

Every Knight Cancer employee is expected to embody our guiding principles: 

• We act BOLDLY—Breakthroughs require pushing the boundaries of science, exploring new frontiers, and thinking differently
• We SUPPORT each other—Respect leads to trust, which leads to excellence
• We work as a CONNECTED team—We must leverage our collective brain power to conquer cancer because no one individual can do it alone

Function/Duties of Position:

The SMMART Oncology Clinical Research Manager 1/ CRM Data Team Manager is responsible for overseeing the clinical research data team operations for the SMMART clinical trials. The Data Team Manager will have direct supervision of the SMMART data team staff members, as well as may participate in program development activities and continuous improvement efforts, in collaboration with the Program Director 1/Sr. Manager of Clinical Research Operations. In support of these activities, the Data Team Manager is deeply involved in clinical data collection processes and workflows to further the efficiency and effectiveness of the SMMART clinical research organization. The Data Team Manager is responsible for facilitating a caring and compassionate patient-focused experience and serves as a liaison between investigators and study partners as well as other stakeholders within the institution. This role is responsible for overseeing data abstraction and curation of clinical metadata (e.g., disease characteristics, analytics test results, clinical events, treatments, etc.) for the SMMART Program. This role will also be responsible for overseeing data operations for SMMART interventional clinical trials, in close collaboration with our study collaborators, which may include development of study materials, electronic data capture systems (EDC), facilitation of LabKey requests, SOPs, and other data quality assurance efforts.

 

Key Responsibilities:

• Managing, developing, and mentoring SMMART Data Team members
• Leading clinical data abstraction from study participants' medical records
• Developing and implementing quality control assurance processes of SMMART clinical trial metadata
• Overseeing report generation for clinical tumor boards, research requests, progress and/or metrics
• Collaborating with stakeholders to define new data elements for collection, per protocol parameters
• Collaborating with the Knight DMS Teams for maintenance and enhancement for of SMMART LabKey
• Creating and maintaining SOPs for data abstraction and management, including maintaining the data team Confluence Wiki and data request prioritization
• Serving as data steward in support of internal and external data sharing
• Serving as subject matter expert in clinical trial data management
• May also directly perform front-line data abstraction to meet SMMART program goals and objectives.

The CRM Data Team Manager will require high level of independence to provide leadership and apply project management principles to move complex, multi-institutional projects through to completion. This role will be an oncology data abstraction subject matter expert, in partnership with SMMART researchers, and is responsible for managing timelines, communications, and strategic partnerships needed for successful progression of data operations for the SMMART Clinical Trials Program. This role requires self-motivation, innovation, adaptability, and high attention to detail, as well as effective communication skills and ability to motivate a team.

Required Qualifications:

Education & experience:

• Bachelor’s degree and 5 years of relevant experience OR
• 9 years of relevant experience, which must include at least 3 years clinical research experience.
  • Relevant experience must include at least 1 year supervisory or lead worker.

Knowledge, skills, and abilities:

• Strong understanding of clinical research requirements with regard to staffing, data collection, systems, and processes.
• Ability to lead a group, serve as a mentor and/or facilitator, and create a positive work environment.
• Ability to ensure and deliver a customer service orientation that translates into timely and reliable support to staff, investigators, sponsor partners and other customers.
• Ability to set appropriate priorities and manage time.
• Excellent communication skills; ability to express and document ideas clearly and concisely in written communications; able to champion personal perspective while maintaining the ability to listen, comprehend, and adjust when required, to other points of view.
• Self-starter with ability to work independently but collaboratively as part of a team to solve problems.
• Strong critical thinking skills, problem-solving abilities, organizational skills and multi-tasking capabilities
• Energy and drive to coordinate multiple projects simultaneously
• Solution-oriented approach to issues
• Ability to use tact and diplomacy to maintain effective working relationships

Preferred Qualifications:

Education & experience:

•  Master’s degree with major courses in relevant field and 3 years of relevant experience.
• Experience working with IITs that utilize precision oncology principles and workflows.
• Experience collaborating with cross-functional teams and stakeholders.
• Experience with abstracting and categorizing robust clinical trial metadata from serial collections and timepoints.

Knowledge, skills, and abilities:

• Deep knowledge and familiarity of methods and operations of Investigator Initiated Trials (IITs), catered toward novel approaches of precision oncology clinical research and serial collections.
• Familiarity of biomarker driven cancer research across multiple disease cohorts.
• Knowledge and understanding of FDA, ICH, HSR, GCP, and other regulatory guidelines that govern clinical research data.
• Skilled in use of EPIC, JIRA, and LabKey platforms.
• Strong familiarity with medical terminology.
• Skilled in developing protocols and standard operating procedures (SOPs).
• Skilled in clinical trial data analysis and report generation.
• Knowledge of IRB processes and regulations.
• Knowledge of data visualization techniques and manipulation.
• Ability to accurately type 60 wpm.
• Clinical research certification (SoCRA, ACRP)

Additional Details:

Apply online. Please be sure to upload a Cover Letter and Resume/CV.

 

We offer a variety of benefits on top of joining a thriving organization:

• Medical, dental and vision coverage at no or low cost to employees
  • Covered 100% for full-time employees and 88% for dependents
• Several retirement plans to choose from with contributions from OHSU
• 25 days a year of paid time off
• 8 days of sick time off
• Commuter subsidies
• Tuition reimbursement
• Access to group life insurance, disability insurance and other supplemental benefits
• Annual Merit Increase
• Growth/Development Opportunities
• Employee discounts to local and major businesses

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All are welcome:Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.