Sirtex Medical Limited

Clinical Research

• 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

Senior Clinical Research Manager

Sales

• The RSM’s primary function is to help Sirtex achieve its sales objectives by prospecting and initiating new accounts and servicing existing accounts.
• The RSM is responsible for all aspects of account management, including but not limited to: supply chain, receivables, training, problem solving, and assisting the account on any and all needs.
• The RSM has ultimate account responsibility as well as the responsibility to meet a pre-determined sales quota.
• Responsibilities include: Developing and implementing account plans for key accounts and partners to generate strategic relationships that will result in sales within assigned territory presentations and training to educate health care professionals.
• Deliver selling presentations – including on site product demonstrations to physicians and other health care professionals.
• Develop an understanding of the market unique to assigned territory.
• Continuously educate oneself on latest information related to disease states and the ever-changing business environment.
• Continuously educate oneself on the newest and most relevant clinical articles that impact Sirtex.
• Develop relationships in all areas of the hospital that are key to Sirtex.
• Cultivate and develop key relationships with Health Care Providers (HCP’s) that manage patient candidates.
• Manage and exceed or reach the set business targets within assigned territory.
• Develop, execute, and oversee strategies and plans to achieve the set business targets.
• Ensures compliance with AdvaMed.
• Execute business meetings with HCP’s.
• Create and maintain accurate records and sales reports.

Senior Clinical Research Manager

Regional Sales Manager – Montreal, Canada, Maritimes