Manager, Clinical Data Management

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 Manager, Clinical Data Management in San Diego! In this role, you will be responsible for leading and managing a team of Clinical Data Analysts focused on clinical data acquisition and management. This important leadership role ensures successful execution of clinical data operations and database development activities to support clinical studies and acts as a key knowledge resource and mentor within the department.

This is a fully onsite position 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. 

• Provides daily leadership and mentorship to Clinical Data Analysts (CDAs), ensuring optimal team performance, professional growth, and high morale.
• Sets clear performance goals and objectives, conducts regular performance reviews, and implements development plans to support career progression.
• Manages team resources effectively, ensuring adequate staffing levels and aligning work priorities with project timelines and phases.
• Oversees clinical data management activities and contributes to database development, data review and programming across multiple projects planning to ensure clinical studies are conducted in compliance with regulatory requirements and company SOPs.
• Develops and implements comprehensive training programs for CDAs, including initial, ongoing, and remedial training as needed.
• Act as a liaison between Clinical Operations and other functional areas, such as Clinical Program Management, Biostatistics, and Clinical Science, to ensure alignment and coordination on project-related activities.
• Facilitates effective communication within the team and with external stakeholders, fostering a collaborative work environment.
• Sponsors and drives continuous process improvement initiatives within Data Management, identifying opportunities for innovation and efficiency.
• Oversees clinical sample data management and processes, ensuring the accurate tracking, storage and documentation of clinical samples throughout the duration of clinical studies.
• Ensures that the Clinical Data Management team is aligned with regulatory expectations and prepared for interactions with regulatory agencies.
• Oversees implementation and maintenance of data exchange and transfer between EDC systems and other database systems such as LIMS/LIS.
• Accountability for creating and implementing a Data Management Plan (DMP) including edit check specifications, electronic data transfer requirements, file or data specification and transfer plans.

Required Education and Experience

• Minimum Bachelor’s degree in Life Sciences or equivalent qualification 
• BA/BS degree and 8-10 years of experience in clinical data management within biotech or medical device industry
• Master's Degree and 5+ years of experience in clinical data management within biotech or medical device industry , or
• PhD, 3+ years of experience in clinical data management within biotech or medical device industry
• Minimum 2 years of experience managing professional associates.

Required Skills 

• Strong understanding of the clinical study process including study design, conduct, management and data analysis.
• Expert knowledge of the requirements of 21 CFR part 11, GCP, and best practices for EDC and clinical database systems.
• Demonstrated ability to effectively manage direct reports.
• Flexibility in daily activities and innovative problem-solving ability.
• Excellent interpersonal, communication, and project management skills.
• Experience using and creating basic reports in SAS a plus
• Experience developing and managing clinical studies with Merative (Zelta) a plus

The annualized base salary range for this role is $118,200 to $196,900 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.