Clinical Data Management Specialist

13 hours ago

Carlsbad, United States Bolt Medical Full time
Clinical Data Management Specialist

Bolt Medical is seeking a highly skilled Clinical Data Management Specialist to join our team. As a key member of our clinical operations team, you will be responsible for managing and analyzing clinical data, serving as the primary contact for data-related questions, and performing administrative tasks within our electronic data capture (EDC) system.

Responsibilities:
  • Review and analyze clinical study data to ensure integrity, completeness, accuracy, and consistency.
  • Serve as the primary contact for research coordinators, clinical monitors, and sponsor field personnel for data-related questions and support.
  • Oversee and provide site/user access to the EDC system and imaging tracking portal, ensuring all users have met required qualifications.
  • Track and resolve outstanding data queries in a timely manner.
  • Review results from multiple core labs and work through questions until resolution.
  • Oversee site/user access and track submissions to the imaging tracking portal.
  • Provide administrative support for adverse event reporting and adjudication activities.
  • Facilitate sponsor coding meetings of study events.
  • Participate in study team meetings to provide ongoing data status.
  • Perform user acceptance testing of EDC systems.
  • Assist in the development and revision of study-specific documentation, including case report forms, data management plans, and EDC training resources.
  • File data management-related documents/correspondence in the eTMF/eISF.
  • Provide process improvement suggestions.
  • Attend, participate, prepare, and distribute meeting minutes and action items for internal data management meetings.
Qualifications:
  • BA/BS degree in life sciences, nursing, or a related scientific field (or equivalent experience).
  • 1-2 years of relevant clinical research experience with associated skill sets.
  • Experience in EDC systems (highly desirable).
  • Previous experience in the pharmaceutical/biotech/medical device industry or within a hospital/academic system.
Knowledge, Skills, and Abilities:
  • Strong interpersonal skills.
  • Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
  • Perform activities in a timely and accurate manner.
  • Strong attention to detail is required.
  • Able to work in a fast-paced, evolving biotech environment with a focus on quality.
  • Able to demonstrate the ability to balance both working independently and collaboratively.
  • Proficient in English language (spoken and written).
  • Strong knowledge of MS Office (Word, Excel, Outlook, and PowerPoint) and Adobe Acrobat.

Bolt Medical is an equal opportunity employer and welcomes applications from diverse candidates. We offer a hybrid work environment with a minimum of 3 days per week in our Carlsbad, California office.

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