Senior Clinical Research Manager at Sirtex

Woburn, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Jan, 26

Salary

194000.0

Posted On

07 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Project Management, GCP, ISO 14155, Regulatory Requirements, Clinical Study Design, Budget Management, Leadership, EDC Systems, Clinical Trial Management Software, Medical Terminology, Resource Allocation, Mentoring, Organizational Skills, Collaboration

Industry

Medical Equipment Manufacturing

Description

Company Description Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated to improving patient outcomes. Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering with physicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achieving this ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagship product, SIR-Spheres® Y-90 resin microspheres, is a targeted radiation therapy for liver cancer. To date, we have delivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueled by our dedication to serving the medical community, maintaining professionalism, fostering a collaborative work culture, nurturing an entrepreneurial spirit, and continuously pursuing innovation and improvement. At Sirtex, we are committed to creating a great workplace. We offer a range of benefits, programs, and services to support our employees, ensuring they have opportunities to contribute to our success and advance their careers. Join our inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance your career, all while delivering innovative healthcare solutions to patients. Job Description 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 Bachelor's 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 $155,000 to $194,000 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 Sirtex’s 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 people’s 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.

Responsibilities

The Senior Clinical Research Manager is responsible for planning, execution, and management of clinical studies for medical devices. This role ensures projects are delivered on time, within budget, and in compliance with regulatory requirements.