Clinical Data Manager at Hologic San Diego, CA

Hologic; San Diego (CA); Hybrid; USD 77,000 - 120,500; Full time

Job summary

Hologic is seeking a Clinical Data Manager in San Diego, CA to oversee data management activities for clinical studies. This position involves study building, data cleaning, and maintaining clinical databases, ensuring compliance and quality standards.

The ideal candidate will have a Bachelor's degree in Life Sciences and 2-5 years of experience in Clinical Data Management within a Clinical Research setting. This hybrid role offers flexibility with onsite and remote work options.

The annual salary ranges from $77,000 to $120,500, depending on qualifications and experience.

Qualifications

• Bachelor's degree in Life Sciences or equivalent.
• 2-5 years of experience in Clinical Data Management.
• Experience with IVD environments.

Responsibilities

• Manage data activities for multiple clinical studies.
• Design, validate, and maintain clinical databases.
• Ensure data accuracy across all clinical data systems.
• Generate, review, and resolve data queries.
• Collaborate with cross-functional teams.

Skills

Clinical Data Management

Study Management

Data Accuracy

Good Clinical Practices

EDC Systems

Education

Bachelor's degree in Life Sciences or equivalent

Tools

Zelta EDC system

Job description

Job Summary

The Clinical Data Manager is responsible for performing end-to-end data management activities including study building using EDC system, data cleaning, query generation, query resolution, and database lock. Responsible for creating and enforcing data review standards. Creates and implements Data Management Plan (DMP) including edit check specifications, electronic data transfer requirements, and File Transfer Spec (FTS). This is a hybrid role with 3 days onsite per week here in San Diego, CA.

Essential Duties and Responsibilities

• Manage data activities for multiple clinical studies while ensuring compliance with procedures and quality standards.
• Design, validate, and maintain clinical databases, including creating annotated CRFs and edit check specifications.
• Provide training, troubleshoot database issues, and ensure data accuracy across all clinical data systems.
• Generate, review, and resolve data queries, ensuring consistency and integrity of clinical data.
• Collaborate with cross-functional teams and serve as a key liaison for data management needs.
• Audit and finalize clinical data and documents, supporting database lock and study completion.

Required Qualifications and Skills

• Minimum Bachelor's degree in Life Sciences or equivalent qualification.
• Minimum of 2-5 years of progressive experience in Clinical Data Management within a Clinical Research industrial setting. Experience in an IVD environment is required.
• Experience in study management, including managing moderate to complex studies.
• Advanced knowledge of good clinical data management practices.
• Advanced knowledge of EDC systems used to manage clinical data. Experience of using Zelta EDC system is a plus.
• Proficient knowledge of technical computer systems.

The annualized base salary range for this role is $77,000 to $120,500 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.