Senior Clinical Research Manager

The Senior Clinical Research Manager is responsible for the planning execution and management of clinical studies that support the development approval and commercialization of medical devices. This role ensures clinical projects are delivered on time within budget and in compliance with regulatory requirements Good Clinical Practice (GCP) and company policies. The Study Manager will work cross-functionally with Regulatory Quality and R&D teams as well as with external investigators vendors and clinical research organizations (CROs).

NOTE: This ideal candidate for this position will be located in the Boston area to report to the office in our hybrid arrangement (3 days/week in office 2 days/week remote).  However we may consider someone in the region with additional flexibility

Qualifications :

• Bachelors degree in life sciences nursing or related field required (advanced degree preferred).
• 5 years of experience in clinical research/clinical affairs within the medical device industry required
• Solid knowledge of GCP ISO 14155 and applicable regulatory requirements (FDA MDR ICH).
• Proven experience managing multi-center clinical studies including site management and CRO oversight.
• Strong organizational skills with the ability to manage multiple projects simultaneously.
• Demonstrated experience in protocol development and clinical study design.
• Familiarity with electronic data capture (EDC) systems and clinical trial management software.
• Knowledge of medical terminology and ability to interpret clinical data.
• Experience in budget management and resource allocation for clinical studies.
• Strong leadership skills with the ability to mentor junior team members.
• Certification in clinical research (e.g. ACRP or SOCRA) is highly desirable.
• Ability to work effectively in a fast-paced dynamic environment with changing priorities.
• Proficiency with Microsoft Office Suite.
• Ability to travel (up to 20%).

The target base salary range for this position will range from $155000 to $194000 annually. Individual compensation for this job requisition will be based on non-discriminatory factors including your geographic location skills experience education and other factors as they relate to the position requirements.  Actual compensation may vary depending on the confirmed job-related skills and experience.

In addition to the expected base compensation this role is eligible to participate in Sirtexs incentive programs (target bonus of 10% for this position) and benefit plans which include paid sick and vacation time health insurance and a generous 401k matching program.

Additional Information :

Do you want to be part of something bigger A team whose impact stretches across the globe making a real difference to the quality of peoples lives.  Sirtex recognizes that well-being financial health and work-life balance are crucial for our employees to achieve personal success. 

Sirtex offers qualified candidates:

• Diverse and flexible work arrangements to achieve the optimum balance between work and personal responsibilities.
• A culture of respect diversity collaboration and innovation fostering inclusiveness and superior performance.
• Attractive compensation and benefit packages which are practical robust and equitable.
• A commitment to support ongoing professional growth through career development on the job experiences and training opportunities.
• Challenging work which supports the development of new and better ways to improve clinical outcomes for oncology treatment around the world.
• An unwavering commitment to company values employee safety and excellence in everything we do.  

Diversity drives innovation; inclusion fosters belonging growth and success. Sirtex believes that it takes multiple perspectives and voices to create a culture and workplace which fosters engagement teamwork and employee satisfaction to perform our best and deliver on commitments. We are dedicated to fostering an environment where all employees feel valued included and can share their ideas so that we can exceed even our own expectations.

Sirtex is An Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability or veteran status age or any other characteristic protected under applicable law.  Sirtex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.

Remote Work :

No

Employment Type :

Full-time