Foster City

POSITION SUMMARY

As part of the Biometrics department, the Clinical Data Associate will work collaboratively in a fast-paced, cross-functional team environment. This individual will play a key role in ensuring accurate, high quality clinical trial data. Overall responsibilities will include supporting clinical data management activities from study start-up through study closure in alignment with the trial objectives and corporate goals, and in accordance with the company Standard Operating Procedures (SOPs) and regulatory directives. 

JOB FUNCTIONS/RESPONSIBILITIES

• Supports the Lead Data Manager (LDM) in reviewing the DM related documentation for quality, completeness, and accuracy; including but not limited to Case Report Forms, Data Validation Specifications, Case Report Form Completion Guidelines, Data Management Plans, Data Transfer Agreements, Medical Coding Guidelines, User Acceptance Testing (UAT) documentation, Communication Plans, etc.
• Assist in the ongoing cleaning database process, including the development and revision of data listings, trackers and patient profiles, reconciliation outputs, queries management (maintaining the Sponsor query log, revision of EDC and follow up with Study Teams).
• Perform UAT of systems and QC of data for assigned clinical trials.
• Collaborate with third parties to ensure external vendors systems and data transfer process is setup and the appropriate documentation is available.
• Review study metric reports, escalating study related issues and assist the Lead Data Manager with the preparation of comprehensive presentations.
• Collaborate with cross-functional team members to ensure the assigned tasks are completed.
• Regularly checks the eTMF to ensure all study DM documents are correctly filed and audit-ready.
• Attends and represents DM effectively on all assigned studies and programs at relevant meetings.
• Other duties as assigned.

QUALIFICATIONS

Education/Experience: 

• Bachelor’s degree preferably in science or health-related discipline.
• 3 years of clinical data management experience in a pharmaceutical/biotech setting.
• Good understanding of clinical trials, regulatory requirements, and GCP.

Knowledge, Skills and Abilities:

• Current knowledge of CDM industry best practice and its application to assigned tasks and responsibilities.
• Strong experience with various clinical database management systems including EDC, eCOA, and ePRO.
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook are preferred.
• Strong and effective oral and written communication, project management, and interpersonal skills.
• Experience in a virtual, global and multi-cultural environment.
• Attention to detail.
• Ability to manage multiple competing tasks

The salary range for this position is $106,000 to $123,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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