Posted Feb 10
American Association for Cancer Research

Clinical Data Project Manager, AACR Project GENIE

Philadelphia, PA, United States Full Time

Job Category: Full-time/Exempt
Department: Project GENIE Coordinating Center/Exec
Reports to: Director, AACR Project GENIE Coordinating Center

About the Project:

AACR Project Genomics, Evidence, Neoplasia, Information, Exchange (GENIE) is a multi-phase, multi-year, international data-sharing project that catalyzes precision oncology through the development of a regulatory-grade cancer registry that aggregates and links clinical-grade cancer genomic data with clinical outcomes from tens of thousands of cancer patients treated at multiple international institutions.

AACR Project GENIE fulfills an unmet need in oncology by providing the statistical power necessary to improve clinical decision-making, particularly in the case of rare cancers and rare variants in common cancers. Additionally, the registry will power novel clinical and translational research.

The data within GENIE will ultimately be shared with the global research community after defined periods of time, and serve as a prototype for aggregating, harmonizing, and sharing clinical-grade, next-generation sequencing data obtained during routine medical practice.

Job Summary:

Experienced project manager and clinical research professional who manages data collection and data quality efforts across participating sites of an expanding international cancer genomics data-sharing project by working with data managers at each participating site and with researchers, project leadership, and strategic informatics partners. The candidate must be able to work both independently and in a team environment. The ideal candidate is highly organized and able to lead and inspire clinical data managers distributed across multiple cancer centers.

Major Duties & Responsibilities:

  • Organizes and leads a team of external data coordinators to harmonize submission of high quality data according to consistent specifications.
  • Coordinates with strategic informatics partners and the site contacts to ensure that all project data:
    •is delivered on time and is compliant with data specifications and SOPs; and
    •meets or exceeds established quality and completeness criteria.
  • Assists in the development of data dictionaries and directives to facilitate collection of consistent data elements across diverse sites.
  • Provides advice and assistance to data managers at participating sites about optimal methods for data submission ranging from automated submission of structured data to manual record abstraction.
  • Reviews research proposals to ascertain the scope of work of clinical data collection that will be required by the sites.
  • Coordinates with clinical project leads and physicians at each site to develop necessary data specifications, and coordinates with informatics partners to develop and test electronic case report forms (eCRFs) for research proposals.
  • Establishes, maintains, and distributes project-related documents for site data managers, clinical investigators, and project leadership, including training materials, policies and SOPs, data specifications, data quality reports, etc.
  • Provides oversight of clinical data collection, including initial and on-going training to site data managers on data collection and data quality through regular teleconferences.
  • Anticipates and identifies deviations from project timelines in a timely manner and works with project teams to address and resolve these deviations.
  • Designs data quality checks on site data, including validating site data against source documentation. Resolves data quality issues in a timely manner.
  • Performs routine descriptive analyses for research cohorts including missing data and unknown data reports and distributes to clinical investigators.
  • Collaborates with and responds to queries from statistical programmers regarding data elements and their specification.
  • Anticipates potential data issues based on working knowledge of site EMRs and works to prevent or remediate the issues.
  • Develops and executes strategies for regular communication with clinical investigators, site contacts, and Steering Committee and keeps them apprised of clinical data projects statuses in collaboration with the AACR Project GENIE Director.
  • Provides staff support to the Data Standards Subcommittee (taking minutes, drafting data specifications, etc).
  • Reviews research proposals to ascertain the scope of work of clinical data collection that will be required by the sites.
  • Willingness to travel as needed.
  • Relationship skills and customer skills.

  • Job Qualifications:

  • Three or more years of experience in clinical data curation, preferably in a multi-site clinical trials setting.
  • Project management experience.
  • Prior experience in oncology clinical trials or clinical research studies in research/academic medical centers.
  • Working knowledge of oncology data systems, including EMR, clinical databases/eCRFs, tumor registries.
  • Experience in electronic medical records abstraction.
  • Excellent verbal and written communications skills.
  • Excellent interpersonal and organizational skills with demonstrated attention to detail.
  • Must be able to prioritize, multi-task, and work in a fast-paced environment.
  • Managerial experience supervising and motivating research assistants or clinical data specialists strongly preferred.
  • Computer literacy with proficiency in MS Office including Word, Excel, and PowerPoint; understanding of MS SharePoint and Trello a plus.

  • Education Requirements:

  • B.A in biology, statistics, informatics, computer science or related discipline. Graduate degree preferred.
  • Nationally-recognized CRA certification (SOCRA, ACRP, etc.) or project management certification (eg PMP) a plus

  • How to Apply:

    Please submit your cover letter and resume (including salary history) to:
    American Association for Cancer Research
    Human Resources
    P.O. Box 40138
    Philadelphia, PA 19106
    Equal Opportunity Employer

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