Clinical Research Manager

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 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 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).

• 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