Clinical Data Management Specialist

2 weeks ago

Carlsbad CA USA, United States Bolt Medical Full time
Job Title: 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.

Key Responsibilities:
  • Review clinical study data, issue queries, and resolve queries to ensure data integrity, completeness, accuracy, and consistency with clinical studies.
  • 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 outstanding data queries and facilitate timely query resolution.
  • Track and review results from multiple Core Labs and work through all questions until resolution.
  • Oversee Site/User access and track submissions to Imaging Tracking portal.
  • Provide administrative support for Adverse Event reporting and adjudication activities.
  • Facilitate in 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 (CRFs), data management plans (DMPs), CRF completion guidelines (CCGs), 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.
Requirements:
  • BA/BS degree in Life Sciences, Nursing, or 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.
Preferred Skills:
  • 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 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.
Location:

Hybrid, Carlsbad-California office at least 3 days per week

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