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    clinical data manager, sr - Durham, United States - Duke University

    Duke University
    Duke University Durham, United States

    3 weeks ago

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    Description


    School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools.

    Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe.

    Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center.

    The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.


    Operations:
    For complex scenarios, recognizes when all types of agreements are necessary. Directs teams to appropriate Duke offices for execution. Serves as an expert resource to multiple study teams/research program regarding regulatory and institutional policies and processes. Develops, oversees adherence, and trains in the use and development of SOPs across multiple study teams/research program(s). Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). Provides oversight and training and lends expertise to multiple study teams. Leads effective facilitation of team meetings in order to achieve objectives. Ensures good communication across multiple study teams, and mentors staff to improve communication strategies.


    Ethics:
    Provides oversight and training to multiple study teams/research program team members who prepare and submit documents needed for regulatory and safety reporting to sponsors and other agencies

    Data:
    Under direct supervision from Biostatistician and PI may perform basic analyses on a variety of data formats. May provide mentorship or education to others on programs and tools for data cleaning and analysis. For multiple study teams, selects data capture methods and discusses advantages and disadvantages of each. Implements data capture methods at the unit, division, or departmental level. Independently designs ECRFs and EDCs to collect data according to protocol.

    Oversees the process of QA, data corrections, and queries used within multiple study teams/the research program, including creating and using QA protocols, queries, summaries, and reports.

    Recognizes trends, and recommends strategies to improve processes or retrain staff.

    Serves as an expert data corrections, queries, and quality assurance resource, including liaising with and being knowledgeable about other related resources at Duke.

    Assists multiple study teams in developing protocols that include strategies and processes to ensure data security and provenance. Recommends and leads implementation of improved processes, policies, and systems to ensure data security and data provenance. Oversees the process of depositing data in repositories. Provides guidance on the selection of the appropriate repository and any data governance requirements. For multiple study teams, provide guidance on the use of data standards. Provides training and oversight into EDC creation using appropriate data standards.

    For studies reporting to the FDA, coordinate the CDISC and CDASH data standard setup and the CDISC dataset transformation tasks.

    Performs de-identification on allowable data to Safe Harbor standards, or on consented data leaving Duke under agreements. Could serve as a Federated Honest Broker. May provide training to others. Serves as an expert resource to multiple study teams/research program with regard to mapping data flow. Predicts areas of vulnerability in the data flow plan. Determines areas where data provenance may be compromised, and helps study teams/research program staff work through solutions. Ensures that study teams are familiar with data flow resources at Duke.

    Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for multiple research teams/research program, as relevant.

    Develops, oversees adherence, and trains to multiple study teams on the results reporting for patients and providers. Provides guidance based on CRU and institutional best practices. Recognizes when 21 CFR Part 11 applies to a project and follow policy related to testing and validation. Provides oversight and training to multiple study teams on validation and testing for EDCs.


    Science:
    Independently develops substantial portions of funding proposals and grants. Assesses and determines solutions for operational shortcomings of proposals. Provide guidance around FAIR data and open science implementation.

    Independently, using scientific proposals from the PI, develops elements of research protocols for complex investigator-initiated studies, across multiple PIs or study teams.

    Uses expertise in research design to provide significant contribution to protocols or research proposals. Provides significant contribution or leadership on accepted, peer-reviewed publication or conference presentation. Mentors others in this area.


    Study and Site Management:
    Mentors, trains, and oversees activities related to how teams communicate with sponsors and/or CROs. Oversees activities related to site visits. For multiple study teams, ensures that studies are conducted in compliance with institutional requirements and other policies. Develops and implements closeout procedures for multiple studies across multiple teams.


    Leadership:
    Encourages staff to take part in professional development opportunities. Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Actively facilitates and leads multiple study team's adoption of change in their working environment. Trains others to communicate effectively within teams. Facilitates resolution of issues associated with teams or communication.


    Description of Portfolio Responsibilities:
    (Effort .

    %):Description of

    Clinical Responsibilities:

    Clinical responsibilities:

    Type of Research:
    This research focuses on scaling up biochemical knowledge for gaining a deeper understanding of the molecular basis of neurodegenerative and neuropsychiatric disorders and finding ways to optimize their treatment

    Special skills:


    former experience in data management is preferredMinimum QualificationsEducationCompletion of an Associate's degreeExperienceWork requires a minimum of six years of research experience.

    A Bachelor's degree may substitute for 2 years required experience.

    Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

    Duke aspires to create a community built on collaboration, innovation, creativity, and belonging.

    Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes.

    To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard.

    All members of our community have a responsibility to uphold these values.


    Essential Physical Job Functions:

    Certain jobs atDuke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities.

    Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
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