Job Details

Job Title: Senior Clinical Data Coordinator

Location: Onsite in Alameda, CA

Pay: $68 - $72/hour ($136k - 144k/year)

Job Summary: The Senior Clinical Data Coordinator will oversee both internal and outsourced data management activities supporting clinical research studies. The role includes leading Clinical Data Management Study subteams and collaborating with Clinical and Regulatory teams to ensure the successful execution of data management tasks.

Key Responsibilities:

Data Management Leadership:

• Lead Clinical Data Management Study subteams.
• Collaborate with Clinical and Regulatory teams to ensure data management alignment with study goals.

Data Management Activities:

• Review clinical study protocols.
• Design Case Report Forms (CRFs).
• Create CRF completion guidelines and data entry guidelines.
• Oversee database design and validation check definitions.
• Conduct data review and manage query generation and resolution.
• Prepare and distribute Data Management (DM) Status Reports.

Coordination and Oversight:

• Ensure timely entry of CRFs by Data Coordinators/Data Entry staff.
• Develop comprehensive Data Management Plans (DMPs).
• Perform Serious Adverse Event (SAE) reconciliation.
• Coordinate quality control audits.

Reporting and Documentation:

• Review final reports, tables, and listings to ensure accuracy and completeness.

Qualifications:

• Education: Bachelor's degree (BS) required.
• Experience: Minimum of 5+ years of relevant experience in clinical data management.