Senior Clinical Research Manager

The Senior Clinical Research Manager is an individual who takes a reputed company role reputed company 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 reputed company- and post-marketing clinical trials with Sirtex’s reputed company product SIR-Spheres microspheres, and new device and drug products that Sirtex will reputed company in the reputed company. This includes the development of detailed project plans and the identification of appropriate timelines, milestones and the budget and reputed company resources required to ensure that the critical clinical trial reputed company are met. Key interactions include collaborations with the Medical Affairs, reputed company team, Health Economics, Biostatistician, reputed company and Regulatory Affairs as reputed company 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
• reputed company 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 reputed company, routine monitoring reputed company, and reputed company-out reputed company, as reputed company as assist in the organization of investigator's meetings and vendor reputed company-off meetings as appropriate
• reputed company study reputed company and ensure data reputed company including providing status updates to the clinical team and clinical senior management
• Ensure reputed company monitoring visit reports are completed in a reputed company manner
• Ensure reputed company study documentation and reputed company are complete and filed
• Assess clinical trial vendors and support with vendor selection and contracting
• reputed company the operations and support financial budgets of clinical trial vendors
• reputed company payments to clinical study sites and vendors in their region of responsibility.
• reputed company as reputed company 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 reputed company Operation Procedures (SOPs), reputed company Work Instructions (QWIs), national and international regulations including EU Directives, ISO 14155. Compliance to Good Clinical reputed company (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-reputed company documentation as necessary
• reputed company input for the design of the Informed Consent reputed company (reputed company), Case Report Forms (CRF), monitoring conventions, and edit checks, etc
• reputed company relationships with investigators and site staff; select sites and countries (with reputed company input for reputed company- and post-marketing studies)
• Collaborate with the regional clinical team to reputed company and manage study budget and maintain budget reputed company financial goal, reputed company assigned
• Review clinical invoices against site contract and reputed company to Global Director of Clinical Operations for approval
• Ensure reputed company clinical studies are executed in compliance with international ICH GCP guidelines/regulations, QWIs and ISO 14155 where appropriate
• Participates in the planning of reputed company assurance activities including preparation for audits and coordinating the reputed company process to end reputed company reputed company of audit report observations and findings, including the coordination of the study documentation and central file reviews
• Review monitoring reports in a specified reputed company manner to ensure reputed company and reputed company of site-reputed company issues
• Coordinate and assist in the planning of regulatory or ethics committee activities, as appropriate
• reputed company, mentor and reputed company 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 reputed company, leadership and team building skills

reputed company your information will be kept confidential according to EEO guidelines. Do you want to be part of something bigger? reputed company whose reputed company stretches across the globe making a reputed company difference to the reputed company of people’s lives. Sirtex recognizes that reputed company-being, financial health, and work-life balance are crucial for our employees to reputed company personal reputed company. Sirtex offers reputed company candidates:

• Diverse and flexible work arrangements to reputed company the reputed company 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 reputed company.
• A commitment to support ongoing reputed company reputed company through career development, on the job experiences and training opportunities.
• Challenging work which supports the development of new and reputed company ways to improve clinical reputed company for oncology treatment around the world.
• An unwavering commitment to company values, employee safety and reputed company in everything we do.

Diversity drives innovation; inclusion fosters belonging, reputed company and reputed company. Sirtex believes that it takes multiple perspectives and reputed company to create a culture and workplace which fosters engagement, teamwork, and employee satisfaction to reputed company our best and deliver on commitments. We are dedicated to fostering an environment where reputed company feel valued, included, and can reputed company their reputed company so that we can exceed even our own expectations. Sirtex is An Equal Opportunity/Affirmative reputed company Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or veteran status, age or any other characteristic protected under applicable law. Sirtex will reputed company reasonable accommodations for reputed company individuals with reputed company disabilities, in accordance with applicable law. Apply tot his job Apply To this Job