Associate Director, Clinical Data Management

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Full Time Professional Berkeley, CA, US

22 days ago Requisition

Salary Range: $ To $ Annually

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 Associate Director, Clinical Data Management 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. This position is hybrid and requires 3 days a week in our Berkeley based office.

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, CRF completion guidelines)
• 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 within the electronic data capture system (EDC)
• Ensure external data are transferred and reconciled with the clinical database
• Oversee, document and or participate in UAT of clinical data systems to be implemented on a project
• Conduct study specific training throughout course of project and maintains user accounts
• Ensure the completion of comprehensive data review of clinical data
• Perform database lock activities in close collaboration with CROs or study team including Biometrics
• Close collaboration with CRO and other study team members regarding data management issues and metrics.
• Performs according to ICH-GCP, other international guidelines, CDISC & Good Clinical Data Management Practices.

Qualifications:

• 6-8 years of Pharmaceutical or Biotech experience required; prior ophthalmology experience is preferred.
• Technical expertise in understanding and implementing clinical data management methods along with experience in the design, build, and testing of EDC platforms and a clinical understanding of medical terminology and adverse event reports
• Knowledge of clinical data management process including study start up, conduct, and database lock phases
• Knowledge of 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
• Ability to work in the office 3 days per week

Compensation Range and Benefits:

• For this role, the anticipated base salary range: $170,000 to $190,000, 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.