Job Description
Clinical Data Manager
San Diego, CA, United States
At Hologic, we're passionate about breaking barriers and improving lives through innovative medical technology. If you're looking to make a meaningful impact in healthcare while advancing your career in a dynamic, collaborative environment, this is your opportunity. Join us and play a vital role in transforming data into actionable insights that drive life-changing outcomes.
**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**
_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.
**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 an Clinical Research industrial setting. Experience in an IVD environment is required
+ Experience in study management, including managing moderate to complex studies.
+ 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.
Be part of a team that's redefining the future of healthcare, one data point at a time. Join Hologic and help us deliver on our mission to enable healthier lives everywhere, every day.
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.
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!
\#LI-RF1 #Mid-level
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.
Job Tags
3 days per week,
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