Clinical Data Manager - Berkeley - Ray Therapeutics, Inc.

    Ray Therapeutics, Inc.
    Ray Therapeutics, Inc. Berkeley

    1 day ago

    Pharmaceutical / Bio-tech
    Description

    Ray Therapeutics, Inc. is a clinical stage biotechnology company developing best-in-class vision restoration therapies for people with degenerative retinal diseases independent of genetic mutation. Reporting to the Vice President, Head of Clinical Operations, Science & Quality, the Clinical Data Manager is responsible for all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing, and routine data review through database lock of clinical trials. The CDM has broad, fundamental knowledge of the data management process and can plan, manage and coordinate all data management activities for assigned studies with minimal guidance and oversee the data management activities outsourced to a clinical resource organization.

    Key Responsibilities include but not limited to the following:

    • Ensure the timely initiation, conduct, and completion of Data Management activities
    • Produce and maintain study-related key Data Management documentation (i.e. Data Management Plan)
    • Develop, define, review eCRF and ensure it meets the data collection requirements of the study through review of the protocol and other supporting documentation
    • Define, review, create edit-checks included in the Data Validation Plan
    • Ensure external data are transferred and reconciled with the clinical database
    • Oversee and or participate in UAT of clinical data systems to be implemented on a project
    • Conducts study specific training throughout course of project, as needed.
    • Ensure the completion of comprehensive data review of clinical data
    • Perform database lock activities in close collaboration with CROs or study team including Biostatistics
    • Communicate with CRO and other collaborators of the project regarding data management issues.
    • Performs according to ICH-GCP, other international guidelines, CDISC & Good Clinical Data Management Practices.

    Qualifications:

    • Minimum Bachelor's degree required
    • Minimum 3 years of industry related experience required
    • Database programming experience with industry standard EDC databases and clinical data management team experience including study start up, conduct, and database lock phases in the pharmaceutical industry.
    • Experience of data management process for clinical trials and the applicable regulations
    • Knowledge of clinical data warehouse systems and data structure standards (CDASH, SDTM)
    • Knowledge with ICH/GCP/CFR guidelines as applicable to global Data Management projects (Phase I-IV)
    • Excellent communication, interpersonal, and presentation skills
    • Technical expertise in understanding and implementing clinical data management methods along with experience in the design, build, and validation of EDC platforms and a clinical understanding of medical terminology and adverse event reports

    Compensation Range and Benefits:

    • For this role, the anticipated base salary range: $109,000 to $127,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
    • Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.

    At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

    All employment is decided on the basis of qualifications, merit, and business need.

    Search Firm Representatives Please Read Carefully

    Ray Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.

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