Manager, Clinical Operations San Diego, CA, United States **Job Summary** Join our dynamic team and make a lasting impact on patient lives. The **Manager, Clinical Operations** is responsible for leading and managing a team of Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs) focused on clinical project execution towards best-in-class compliant clinical evidence. This important leadership role ensures successful execution of clinical operations at the site level and acts as a key knowledge resource and mentor for clinical operations within the department. **Essential Duties and Responsibilities** • Provides daily leadership and mentorship to CRAs and CTAs, 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 the planning, execution, and monitoring of clinical trials to ensure they are conducted in compliance with regulatory requirements and company SOPs. • Develops and implements comprehensive training programs for CTAs and CRAs, including initial, ongoing, and remedial training as needed. • Act as a liaison between Clinical Operations and other functional areas, such as Clinical Program Management, Clinical Data 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. • Ensures clinical operations activities and SOPs adhere to applicable regulatory requirements. • Sponsors and drives continuous process improvement initiatives within Clinical Operations, identifying opportunities for innovation and efficiency. • Oversees clinical sample management and processes, ensuring the accurate tracking, storage and documentation of clinical samples throughout the duration of clinical studies. • Ensures quality control (QC) of project Trial Master Files (TMFs). • Ensures that the Clinical Operations team is aligned with regulatory expectations and prepared for interactions with regulatory agencies. **Qualifications** _Education_ • Minimum Bachelor’s degree in Life Sciences or equivalent qualification _Experience_ • Minimum 8 years of progressive experience in clinical research within biotech or medical device industry. Minimum 5 years with Master’s Degree. Minimum 3 years with PhD. • Minimum 2 years of experience managing professional associates. • Experience in resource and budget management and allocations across projects is required. • Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. _Skills_ • Excellent working knowledge of GCP, clinical and regulatory affairs. • Excellent project management skills with ability to deliver projects on time and on budget to support corporate goals and objectives. • Ability to conceptualize abstract processes and visualize solutions to complex problems. • Expert knowledge of clinical trial and research principles. • Strong understanding of the clinical study process including study design, conduct, management and data analysis. • Flexibility in daily activities and innovative problem solving skills. • Demonstrated strong project management skills. • Excellent interpersonal skills. **Additional Details:** + 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. _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._