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.