Lead Clinical Data Manager

Regulatory Jobs

Foster City (CA)

On-site

USD 136,000 - 176,000

Full time

3 days ago
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Benefits offered by this job

Discretionary bonus
Stock-based incentives
Medical, dental, vision & life ins.

Job summary

Gilead Sciences Inc. seeks a Clinical Data Management (CDM) lead to oversee data collection, quality checks and reporting across clinical studies.

You will design CRF/eCRF, review protocols and coordinate CROs, vendors and investigators to ensure timely, accurate data delivery in line with regulatory expectations. The role requires a Bachelor’s degree with several years of CDM experience or a Master’s degree with relevant work history.

Qualifications

  • CDM leadership experience and data management expertise required.
  • Experience leading small projects and project teams preferred.
  • Strong knowledge of regulatory requirements (FDA/EMA) and CDM best practices.

Responsibilities

  • Lead one or more CDM studies or projects of increasing complexity.
  • Review study protocols and assist site teams to collect data per protocol.
  • Identify, track and resolve CDM queries and issues.
  • Provide guidance to CROs, vendors and investigators on CDM requirements.
  • Lead CRF/eCRF design and data transfer processes.
  • Ensure data completeness, accuracy and regulatory compliance.

Skills

CDM leadership
Data management
Regulatory knowledge
Project management
Mentoring
Vendor management

Education

Bachelor's Degree + 6 years experience
Master's degree + 4 years experience

Tools

Web-based EDC

Job description

Gilead Sciences Inc. seeks a Clinical Data Management (CDM) lead to oversee data collection, quality checks and reporting across clinical studies.

You will design CRF/eCRF, review protocols and coordinate CROs, vendors and investigators to ensure timely, accurate data delivery in line with regulatory expectations. The role requires a Bachelor’s degree with several years of CDM experience or a Master’s degree with relevant work history.

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