Job Description

Job Title: Data Management and Entry Analyst II

Position Type: Contract-to-Hire, 520 hours

Pay Rate: $40–$48/hour

Location: Pleasanton, CA (Hybrid – 3 days onsite per week)

Overview:

This role supports a regional clinical trials program responsible for advancing clinical research activities across Northern California. The Digital Solutions team within the program oversees the digital infrastructure that supports operational workflows, tools, data management, and analytics. Key stakeholders include leadership, Finance, Operations, Regulatory, Compliance, Quality, and clinical study teams. Reporting to the Operations Lead of Digital Solutions, the Data Management and Entry Analyst II ensures the accuracy, integrity, and usability of clinical trial data. The ideal candidate is detail-oriented, technically proficient, and experienced in clinical research within FDA-regulated environments.

Core Responsibilities

• Perform clinical trial data tasks including data entry, reconciliation, and quality control.
• Extract and process clinical and administrative data, including PHI, from multiple sources using internal digital tools.
• Conduct data and image processing tasks such as cleaning, organization, de-identification, and issue resolution.
• Generate standard and ad hoc reports for internal teams and external stakeholders.

Additional Responsibilities

• Manage user access for systems such as Clinical Trial Management Systems (CTMS) and Electronic Document Management Systems (EDMS).
• Provide Tier 1 user support and collaborate with IT for technical issue resolution.
• Participate in User Acceptance Testing (UAT) including executing test scripts and documenting results.
• Coordinate temporary access for external monitors and auditors.
• Assist with the creation of analytics dashboards and data visualizations.
• Maintain accurate documentation, including SOPs, work instructions, and process diagrams.
• Process and prioritize de-identification requests for patient imaging data.

Qualifications

• Bachelor’s degree required.
• 3–4 years of clinical research experience within healthcare, CROs, biopharma, or sponsor organizations.
• Experience working with PHI (protected health information) in an FDA-regulated setting.
• Proficiency in Microsoft Office (Excel, Word, PowerPoint, Outlook).
• Strong verbal and written communication skills with the ability to explain technical topics clearly.
• Ability to work independently while contributing effectively to a collaborative team.
• Exceptional attention to detail and strong organizational skills.
• Proven problem-solving ability and comfort working under tight deadlines.
• Willingness and ability to learn new tools and systems quickly.

Preferred Qualifications

• Familiarity with diagramming tools such as Microsoft Visio or Lucidchart.
• Experience working with clinical trial systems such as EDMS, CTMS, EDC, and eTMF.

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