Job Description

Eastridge Workforce Solutions is a premier provider of workforce management services, dedicated to connecting skilled professionals with meaningful opportunities. Currently, Eastridge seeks a Senior Clinical Data Manager for a company focused on developing innovative products for the ophthalmic market.

Responsibilities

Project Management

• Represent Data Management in study team meetings, providing metrics and guidance on data-related issues.
• Oversee Data Management activities from study initiation to closeout.
• Develop and maintain Data Management timelines for assigned studies.
• Manage data quality and timeliness from external service providers (e.g., labs, medical coders).

Data Management Documents

• Create and maintain Data Management documentation (e.g., Data Management Plans, Data Review Guidelines).
• Prepare training materials for investigators, in-house teams, and site staff.
• Keep project documentation audit-ready, including vendor files.
• Support Clinical Programmers in creating Data Transfer Agreements.

Data Review

• Lead data review across studies to identify trends, quality issues, and outliers.
• Reconcile and validate data from external sources.

Database Development and Testing

• Assist in creating CRF and Edit Check Specifications.
• Conduct User Acceptance Testing (UAT) for clinical databases.

EDC User Management

• Manage user access to Electronic Data Capture (EDC) systems for all studies.

Collaboration

• Work with Clinical Study Teams to resolve discrepancies and meet timelines.
• Collaborate with cross-functional teams to generate reports and facilitate data review.
• Provide feedback on study protocols related to data collection.

Process Improvement

• Contribute to updates of Data Management SOPs, work instructions, and templates.
• Develop and enhance departmental processes.

Requirements

• Education: Bachelor’s degree in biological sciences, nursing, or a related field preferred.
• Experience: Minimum 5 years in clinical data management, ideally in pharmaceuticals or medical devices.
• Familiarity with FDA/ICH guidelines, clinical trial processes, and Good Clinical Data Management Practices (GCDMP).
• Hands-on experience with EDC systems (e.g., MedNet, Rave, Veeva Vault EDC).
• Skills: Strong multi-tasking, problem-solving, and communication skills.
• Project management and documentation writing expertise.
• Knowledge of CDISC standards (CDASH, SDTM).
• Desirable: Familiarity with the ophthalmology therapeutic area.
• Experience creating Case Report Forms and Edit Check Specifications.

This position offers an opportunity to play a pivotal role in advancing ophthalmic innovations while ensuring data integrity and compliance with industry standards.

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Benefits : Use this link bit.ly/4cGUQSh to learn more about benefits available to Eastridge’s temporary employees. From time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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