Clinical Data Management Specialist

3 weeks ago

Carlsbad, United States Bolt Medical Full time

DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.

RECRUITERS: DO NOT CONTACT.


Position Overview: The Clinical Data Management Specialist will manage and analyze clinical data, serve as the primary contact for data related questions, and perform administrative tasks within the electronic data capture (EDC) system to support multiple clinical trials within a medical device startup company.

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 user have met required qualifications.
  • Track outstanding data queries and facilitates 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.
  • Participates 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.
  • Will adhere to applicable SOPs, WIs, policies, training, and regulatory requirements.

Qualification:

Education:

  • BA/BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience).

Required 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 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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