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Clinical Data Manager

San Diego, CA, United States

Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by enabling healthier lives everywhere, every day.

Our Diagnostics Clinical Affair group is hiring for a Clinical Data Manager in San Diego! In this individual-contributor role, you will be 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 position with 3 days onsite, and based out of San Diego, CA.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

+ 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.

+ Recommends and initiates systems to improve quality and efficiency.

+ Recommends use of new technology approaches.

+ Provides guidance and training to lower level employees as needed.

+ May administer CDM applications, users accounts, and access levels required to manage clinical data.

Required Education and Experience

+ Minimum Bachelor’s degree in Life Sciences or equivalent qualification

+ BA/BS degree with minimum of 5 - 8 years of progressive experience in Clinical Data Management within an Clinical Research industrial setting and Bachelor’s degree. Experience in an IVD environment is required.

+ Experience in study management, including managing moderate to complex studies..

Required Skills

+ Advanced knowledge 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.

+ Understanding of Clinical Study process, including study design, conduct, management, and data analysis.

The annualized base salary range for this role is $97,400 to $152,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs, and market demand.

Why Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

If you have the right skills and experience, apply today!

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Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

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