Senior Clinical Research Manager

Sirtex Medical is a global leader in healthcare, with offices in the U.S., Australia, Germany, and Singapore, dedicated toimproving patient outcomes.

Our mission is to be at the forefront of minimally invasive cancer and embolization therapies. By partnering withphysicians, we aim to provide innovative products that enhance patient outcomes and simplify treatments. Achievingthis ambitious goal requires passionate and talented individuals who are committed to making a difference. Our flagshipproduct, SIR-Spheres Y-90 resin microspheres, is a targeted radiation therapy for liver cancer. To date, we havedelivered over >150K doses across 50+ countries, significantly impacting patients' lives worldwide. Our success is fueledby 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 tosupport our employees, ensuring they have opportunities to contribute to our success and advance their careers. Joinour inclusive community, where you can collaborate with talented colleagues, bring your ideas to life, and advance yourcareer, all while delivering innovative healthcare solutions to patients.

The Senior Clinical Research Manager is an individual who takes a lead role within Clinical Operations in the coordination and implementation of clinical IDE-FDA studies, Investigator Initiated studies and Registries.

The Senior Clinical Research Manager is responsible for the implementation and management of Sirtex Technology Pty Ltd and Sirtex Medical clinical research activities in the region, including both pre- and post-marketing clinical trials with Sirtex's lead product SIR-Spheres microspheres, and new device and drug products that Sirtex will develop in the future. This includes the development of detailed project plans and the identification of appropriate timelines, milestones and the budget and staffing resources required to ensure that the critical clinical trial projects are met. Key interactions include collaborations with the Medical Affairs, Commercial team, Health Economics, Biostatistician, Quality and Regulatory Affairs as well as Physician Investigators and appropriate medical and scientific research organizations.

In order to execute these responsibilities, the Senior Clinical Research Manager will support managing and developing the regional Sirtex clinical research staff, contract research organizations (CROs) and investigational site activities for which Sirtex is responsible in the region. The individual in the role will also be responsible for participating in the development of processes, implementing and maintaining departmental policies, procedures, and strategies to ensure that trials are performed in accordance with Good Clinical Practices (GCP).

Primary Responsibilities:

• Coordinates the study contract and budget process with sites, investigators, and required Sirtex personnel
• Creates and manages the internal study plans and timelines
• Provide study-specific training and leadership to clinical research staff, Clinical Research Organization (CRO), Clinical Research Associates (CRA), sites and other contract personnel
• May conduct initiation meetings, site selection visits, routine monitoring visits, and close-out visits, as well as assist in the organization of investigator's meetings and vendor kick-off meetings as appropriate
• Track study progress and ensure data integrity including providing status updates to the clinical team and clinical senior management
• Ensure all monitoring visit reports are completed in a timely manner
• Ensure all study documentation and contracts are complete and filed
• Assess clinical trial vendors and support with vendor selection and contracting
• Oversee the operations and support financial budgets of clinical trial vendors
• Track payments to clinical study sites and vendors in their region of responsibility.
• Act as liaison between internal departments, investigational sites, and vendors
• Ensure the completion of routine administrative duties such as arranging meetings and/or conferences, recording minutes, document copying and distribution and maintaining study files
• Ensure regulatory compliance of investigational sites with company Standard Operation Procedures (SOPs), Quality Work Instructions (QWIs), national and international regulations including EU Directives, ISO 14155. Compliance to Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with the Study Management Team (SMT) and Health Economics to design clinical study protocols consistent with the clinical development initiatives to ensure appropriate patient recruitment, detection of data trends and to ensure study objectives are met
• Prepare study-related documentation as necessary
• Provide input for the design of the Informed Consent Form (ICF), Case Report Forms (CRF), monitoring conventions, and edit checks, etc
• Develop relationships with investigators and site staff; select sites and countries (with Commercial input for pre- and post-marketing studies)
• Collaborate with the regional clinical team to develop and manage study budget and maintain budget within financial goal, when assigned
• Review clinical invoices against site contract and forward to Global Director of Clinical Operations for approval
• Ensure all clinical studies are executed in compliance with international ICH GCP guidelines/regulations, QWIs and ISO 14155 where appropriate
• Participates in the planning of quality assurance activities including preparation for audits and coordinating the resolution process to end point resolution of audit report observations and findings, including the coordination of the study documentation and central file reviews
• Review monitoring reports in a specified timeline manner to ensure quality and resolution of site-related issues
• Coordinate and assist in the planning of regulatory or ethics committee activities, as appropriate
• Coach, mentor and provide guidance to the CTA and other junior Clinical Operations staff

• Bachelor's degree required or Master's preferred
• Minimum of 6-8 years of clinical study experience with on-site management responsibility
• Experience leading IDE studies is required
• At least 4 years of monitoring experience in pharmaceutical, medical device, bio- technology or CRO companies required
• Understanding of ISO 14155 and fully conversant with ICH GCP guidelines, EU Directives and regulatory requirements
• Strong clinical study management skills including management of vendors at site level
• Excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team building skills

All your information will be kept confidential according to EEO guidelines.

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.